Trial Outcomes & Findings for Surgical Pain After Inguinal Hernia Repair (SPAIHR) (NCT NCT00551135)

Last Updated: 2021-01-25

Results Overview

m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

425 participants

Primary outcome timeframe

24 hours post surgery

Results posted on

2021-01-25

Participant Flow

Male subjects were enrolled at 34 centers and participated in the study between 18 January 2008 and 14 September 2009.

Participant milestones

Participant milestones
Measure	Pregabalin 50 mg Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Overall Study STARTED	108	106	103	108
Overall Study COMPLETED	103	104	98	103
Overall Study NOT COMPLETED	5	2	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin 50 mg Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Overall Study Adverse Event	1	0	1	1
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Other	3	2	1	2
Overall Study Withdrawal by Subject	1	0	3	1

Baseline Characteristics

Surgical Pain After Inguinal Hernia Repair (SPAIHR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin 50 mg n=108 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=106 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=103 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=108 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.	Total n=425 Participants Total of all reporting groups
Age, Customized Between 18 and 44 years	43 participants n=5 Participants	37 participants n=7 Participants	40 participants n=5 Participants	46 participants n=4 Participants	166 participants n=21 Participants
Age, Customized Between 45 and 64 years	48 participants n=5 Participants	58 participants n=7 Participants	52 participants n=5 Participants	47 participants n=4 Participants	205 participants n=21 Participants
Age, Customized >=65 years	17 participants n=5 Participants	11 participants n=7 Participants	11 participants n=5 Participants	15 participants n=4 Participants	54 participants n=21 Participants
Sex/Gender, Customized	108 participants n=5 Participants	106 participants n=7 Participants	103 participants n=5 Participants	108 participants n=4 Participants	425 participants n=21 Participants

PRIMARY outcome

Timeframe: 24 hours post surgery

Population: Modified Intent-to-Treat Population (MITT): all subjects included in intent-to-treat population who took study medication 12 and 2 hours prior to surgery, had no complications during herniorrhaphy, and had the post-surgery primary efficacy measurement. Data from 1 site excluded due to Good Clinical Practices (GCP) deviations.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery	5.2 scores on scale Standard Error 0.24	5.4 scores on scale Standard Error 0.25	4.7 scores on scale Standard Error 0.24	5.4 scores on scale Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])

Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting Baseline	1.3 scores on scale Standard Error 0.17	1.2 scores on scale Standard Error 0.18	1.0 scores on scale Standard Error 0.17	1.1 scores on scale Standard Error 0.17
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting 2 h BS (n=102, 99, 101, 101)	0.7 scores on scale Standard Error 0.10	0.6 scores on scale Standard Error 0.10	0.8 scores on scale Standard Error 0.10	0.9 scores on scale Standard Error 0.10
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting 1 h PS (n=92, 91, 91, 91)	3.6 scores on scale Standard Error 0.24	4.1 scores on scale Standard Error 0.24	3.1 scores on scale Standard Error 0.24	4.1 scores on scale Standard Error 0.24
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting 2 h PS (n=96, 93, 100, 96)	3.3 scores on scale Standard Error 0.21	3.7 scores on scale Standard Error 0.21	3.2 scores on scale Standard Error 0.20	3.5 scores on scale Standard Error 0.21
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting 3 h PS (n=100, 98, 101, 101)	2.7 scores on scale Standard Error 0.19	3.3 scores on scale Standard Error 0.19	2.9 scores on scale Standard Error 0.18	3.1 scores on scale Standard Error 0.19
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting Day 2 PS (n=102, 98, 101, 100)	3.5 scores on scale Standard Error 0.22	3.6 scores on scale Standard Error 0.23	3.4 scores on scale Standard Error 0.22	3.7 scores on scale Standard Error 0.22
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting Day 3 PS (n=102, 98, 100, 101)	2.7 scores on scale Standard Error 0.22	3.0 scores on scale Standard Error 0.22	3.0 scores on scale Standard Error 0.22	2.8 scores on scale Standard Error 0.22
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting Day 4 PS (n=101, 99, 99, 101)	2.2 scores on scale Standard Error 0.20	2.2 scores on scale Standard Error 0.20	2.4 scores on scale Standard Error 0.20	2.3 scores on scale Standard Error 0.20
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting Day 5 PS (n=101, 99, 98, 100)	1.7 scores on scale Standard Error 0.18	1.8 scores on scale Standard Error 0.18	1.9 scores on scale Standard Error 0.18	2.0 scores on scale Standard Error 0.18
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting Day 6 PS (n=100, 99, 98, 99)	1.6 scores on scale Standard Error 0.17	1.6 scores on scale Standard Error 0.17	1.8 scores on scale Standard Error 0.17	1.7 scores on scale Standard Error 0.17
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting Day 7 PS (n=96, 93, 91, 93)	1.5 scores on scale Standard Error 0.17	1.5 scores on scale Standard Error 0.17	1.8 scores on scale Standard Error 0.18	1.5 scores on scale Standard Error 0.17
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting EOT (n=101, 99, 100, 100)	1.0 scores on scale Standard Error 0.15	1.3 scores on scale Standard Error 0.15	1.3 scores on scale Standard Error 0.15	1.2 scores on scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])

NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain).

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Numeric Rating Scale (NRS): Current Pain With Movement - Walking Baseline	1.9 scores on scale Standard Error 0.23	1.6 scores on scale Standard Error 0.24	1.9 scores on scale Standard Error 0.23	2.0 scores on scale Standard Error 0.23
Numeric Rating Scale (NRS): Current Pain With Movement - Walking 2 h BS (n=102, 98, 101, 101)	1.2 scores on scale Standard Error 0.12	1.1 scores on scale Standard Error 0.12	1.2 scores on scale Standard Error 0.12	1.2 scores on scale Standard Error 0.12
Numeric Rating Scale (NRS): Current Pain With Movement - Walking 1 h PS (n=69, 62, 63, 60)	3.2 scores on scale Standard Error 0.29	3.9 scores on scale Standard Error 0.32	2.9 scores on scale Standard Error 0.31	3.7 scores on scale Standard Error 0.32
Numeric Rating Scale (NRS): Current Pain With Movement - Walking 2 h PS (n=84, 76, 84, 80)	3.3 scores on scale Standard Error 0.27	3.4 scores on scale Standard Error 0.28	3.1 scores on scale Standard Error 0.25	3.6 scores on scale Standard Error 0.27
Numeric Rating Scale (NRS): Current Pain With Movement - Walking 3 h PS (n=96, 91, 93, 94)	3.1 scores on scale Standard Error 0.22	3.6 scores on scale Standard Error 0.23	3.0 scores on scale Standard Error 0.22	3.3 scores on scale Standard Error 0.23
Numeric Rating Scale (NRS): Current Pain With Movement - Walking Day 2 PS (n=102, 98, 101, 100)	3.3 scores on scale Standard Error 0.23	3.8 scores on scale Standard Error 0.23	3.3 scores on scale Standard Error 0.23	3.9 scores on scale Standard Error 0.23
Numeric Rating Scale (NRS): Current Pain With Movement - Walking Day 3 PS (n=102, 98, 100, 101)	2.7 scores on scale Standard Error 0.21	3.0 scores on scale Standard Error 0.22	2.8 scores on scale Standard Error 0.21	2.9 scores on scale Standard Error 0.21
Numeric Rating Scale (NRS): Current Pain With Movement - Walking Day 4 PS (n=101, 99, 99, 101)	2.2 scores on scale Standard Error 0.20	2.2 scores on scale Standard Error 0.20	2.1 scores on scale Standard Error 0.20	2.2 scores on scale Standard Error 0.20
Numeric Rating Scale (NRS): Current Pain With Movement - Walking Day 5 PS (n=101, 99, 98, 100)	1.7 scores on scale Standard Error 0.17	1.8 scores on scale Standard Error 0.17	1.8 scores on scale Standard Error 0.17	1.9 scores on scale Standard Error 0.17
Numeric Rating Scale (NRS): Current Pain With Movement - Walking Day 6 PS (n=100, 99, 98, 99)	1.5 scores on scale Standard Error 0.17	1.6 scores on scale Standard Error 0.17	1.7 scores on scale Standard Error 0.17	1.6 scores on scale Standard Error 0.17
Numeric Rating Scale (NRS): Current Pain With Movement - Walking Day 7 PS (n=96, 93, 91, 93)	1.3 scores on scale Standard Error 0.17	1.4 scores on scale Standard Error 0.17	1.5 scores on scale Standard Error 0.17	1.3 scores on scale Standard Error 0.17
Numeric Rating Scale (NRS): Current Pain With Movement - Walking EOT (n=101, 99, 100, 100)	1.1 scores on scale Standard Error 0.16	1.2 scores on scale Standard Error 0.16	1.3 scores on scale Standard Error 0.16	1.2 scores on scale Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])

NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing Baseline	2.4 scores on scale Standard Error 0.25	1.8 scores on scale Standard Error 0.26	2.2 scores on scale Standard Error 0.26	2.1 scores on scale Standard Error 0.26
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing 2 h BS (n=102, 99, 101, 101)	1.4 scores on scale Standard Error 0.15	1.5 scores on scale Standard Error 0.15	1.6 scores on scale Standard Error 0.15	1.8 scores on scale Standard Error 0.15
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing 1 h PS (n=95, 91, 93, 90)	4.4 scores on scale Standard Error 0.26	4.8 scores on scale Standard Error 0.26	3.7 scores on scale Standard Error 0.26	4.6 scores on scale Standard Error 0.26
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing 2 h PS (n=96, 93, 99, 97)	4.1 scores on scale Standard Error 0.23	4.3 scores on scale Standard Error 0.24	3.8 scores on scale Standard Error 0.23	4.3 scores on scale Standard Error 0.23
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing 3 h PS (n=100, 99, 100, 100)	3.8 scores on scale Standard Error 0.22	4.1 scores on scale Standard Error 0.22	3.8 scores on scale Standard Error 0.22	3.9 scores on scale Standard Error 0.22
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing Day 2 PS (n=102, 98, 101, 100)	4.6 scores on scale Standard Error 0.25	5.1 scores on scale Standard Error 0.26	4.5 scores on scale Standard Error 0.25	5.2 scores on scale Standard Error 0.25
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing Day 3 PS (n=102, 98, 101, 100)	4.3 scores on scale Standard Error 0.24	4.5 scores on scale Standard Error 0.25	4.3 scores on scale Standard Error 0.25	4.5 scores on scale Standard Error 0.24
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing Day 4 PS (n=101, 99, 99, 101)	3.6 scores on scale Standard Error 0.25	3.6 scores on scale Standard Error 0.25	3.6 scores on scale Standard Error 0.25	3.9 scores on scale Standard Error 0.25
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing Day 5 PS (n=101, 99, 98, 100)	2.8 scores on scale Standard Error 0.24	3.1 scores on scale Standard Error 0.24	3.2 scores on scale Standard Error 0.24	3.8 scores on scale Standard Error 0.24
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing Day 6 PS (n=100, 99, 98, 99)	2.6 scores on scale Standard Error 0.23	2.8 scores on scale Standard Error 0.23	2.9 scores on scale Standard Error 0.23	3.2 scores on scale Standard Error 0.23
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing Day 7 PS (n=96, 93, 91, 93)	2.4 scores on scale Standard Error 0.23	2.5 scores on scale Standard Error 0.24	2.5 scores on scale Standard Error 0.24	2.7 scores on scale Standard Error 0.23
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing EOT (n=101, 99, 100, 100)	1.9 scores on scale Standard Error 0.21	2.0 scores on scale Standard Error 0.21	2.3 scores on scale Standard Error 0.21	2.3 scores on scale Standard Error 0.21

SECONDARY outcome

Timeframe: 1 hour through 48 hours post surgery

Population: MITT; 1 site excluded for GCP deviations; n=subjects with analyzable data at observation (pregabalin 50, 150, and 300 mg, and placebo, respectively).

NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain).

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing Sitting (n=100, 99, 101, 101)	146.22 scores on scale Standard Error 8.185	158.90 scores on scale Standard Error 8.261	148.25 scores on scale Standard Error 8.115	155.57 scores on scale Standard Error 8.125
Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing Walking (n=97, 91, 95, 96)	143.82 scores on scale Standard Error 8.981	162.70 scores on scale Standard Error 9.575	143.40 scores on scale Standard Error 9.063	161.74 scores on scale Standard Error 9.235
Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing Coughing (n=101, 99, 100, 101)	202.93 scores on scale Standard Error 9.635	219.69 scores on scale Standard Error 9.778	199.13 scores on scale Standard Error 9.645	220.34 scores on scale Standard Error 9.601

SECONDARY outcome

Timeframe: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS

NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Numerical Rating Scale (NRS): Current Pain at Rest Day 6 PS (n=100, 99, 98, 98)	1.3 scores on scale Standard Error 0.15	1.4 scores on scale Standard Error 0.15	1.4 scores on scale Standard Error 0.15	1.5 scores on scale Standard Error 0.15
Numerical Rating Scale (NRS): Current Pain at Rest 2 h BS (n=102, 99, 101, 101)	0.9 scores on scale Standard Error 0.11	0.7 scores on scale Standard Error 0.12	0.8 scores on scale Standard Error 0.11	0.7 scores on scale Standard Error 0.11
Numerical Rating Scale (NRS): Current Pain at Rest 1 h PS (n=102, 97, 100, 100)	3.3 scores on scale Standard Error 0.20	3.7 scores on scale Standard Error 0.20	2.9 scores on scale Standard Error 0.20	3.8 scores on scale Standard Error 0.20
Numerical Rating Scale (NRS): Current Pain at Rest 2 h PS (n=102, 99, 101, 101)	3.1 scores on scale Standard Error 0.18	3.2 scores on scale Standard Error 0.18	2.7 scores on scale Standard Error 0.18	3.0 scores on scale Standard Error 0.18
Numerical Rating Scale (NRS): Current Pain at Rest 3 h PS (n=102, 99, 101, 101)	2.5 scores on scale Standard Error 0.17	2.7 scores on scale Standard Error 0.18	2.6 scores on scale Standard Error 0.17	2.7 scores on scale Standard Error 0.17
Numerical Rating Scale (NRS): Current Pain at Rest Day 2 PS (n=101, 99, 100, 101)	3.2 scores on scale Standard Error 0.22	3.3 scores on scale Standard Error 0.23	3.3 scores on scale Standard Error 0.22	3.3 scores on scale Standard Error 0.22
Numerical Rating Scale (NRS): Current Pain at Rest Day 3 PS (n=102, 99, 100, 100)	2.5 scores on scale Standard Error 0.19	2.7 scores on scale Standard Error 0.19	2.2 scores on scale Standard Error 0.19	2.3 scores on scale Standard Error 0.19
Numerical Rating Scale (NRS): Current Pain at Rest Day 4 PS (n=101, 99, 99, 101)	2.0 scores on scale Standard Error 0.18	2.0 scores on scale Standard Error 0.18	1.9 scores on scale Standard Error 0.18	1.8 scores on scale Standard Error 0.18
Numerical Rating Scale (NRS): Current Pain at Rest Day 5 PS (n=101, 98, 98, 100)	1.4 scores on scale Standard Error 0.17	1.8 scores on scale Standard Error 0.17	1.8 scores on scale Standard Error 0.17	1.7 scores on scale Standard Error 0.17
Numerical Rating Scale (NRS): Current Pain at Rest Day 7 PS (n=96, 93, 90, 93)	1.2 scores on scale Standard Error 0.14	1.4 scores on scale Standard Error 0.14	1.3 scores on scale Standard Error 0.14	1.3 scores on scale Standard Error 0.14
Numerical Rating Scale (NRS): Current Pain at Rest Day 8 PS (n=60, 62, 53, 60)	1.3 scores on scale Standard Error 0.19	1.2 scores on scale Standard Error 0.19	1.2 scores on scale Standard Error 0.20	1.1 scores on scale Standard Error 0.19
Numerical Rating Scale (NRS): Current Pain at Rest Day 9 PS (n=21, 24, 25, 22)	0.4 scores on scale Standard Error 0.21	1.0 scores on scale Standard Error 0.20	0.6 scores on scale Standard Error 0.20	1.5 scores on scale Standard Error 0.19
Numerical Rating Scale (NRS): Current Pain at Rest Day 10 PS (n=11, 11, 13, 11)	0.5 scores on scale Standard Error 0.33	1.0 scores on scale Standard Error 0.33	0.9 scores on scale Standard Error 0.31	0.9 scores on scale Standard Error 0.29

SECONDARY outcome

Timeframe: 1 through 48 hours post surgery (PS)

Population: MITT; data from 1 site excluded due to GCP deviations.

NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC)	133.8 score on scale Standard Error 7.88	141.3 score on scale Standard Error 7.99	132.3 score on scale Standard Error 7.78	135.1 score on scale Standard Error 7.86

SECONDARY outcome

Timeframe: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS

NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain).

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Numeric Rating Scale (NRS): Average Pain 2 h BS (n=102, 99, 101, 101)	1.3 scores on scale Standard Error 0.15	1.3 scores on scale Standard Error 0.15	1.3 scores on scale Standard Error 0.15	1.4 scores on scale Standard Error 0.15
Numeric Rating Scale (NRS): Average Pain 1 h PS (n=101, 96, 99, 99)	2.8 scores on scale Standard Error 0.19	3.0 scores on scale Standard Error 0.20	2.5 scores on scale Standard Error 0.19	3.2 scores on scale Standard Error 0.19
Numeric Rating Scale (NRS): Average Pain 2 h PS (n=101, 97, 101, 99)	3.0 scores on scale Standard Error 0.18	3.2 scores on scale Standard Error 0.18	2.8 scores on scale Standard Error 0.18	3.1 scores on scale Standard Error 0.18
Numeric Rating Scale (NRS): Average Pain 3 h PS (n=102, 99, 101, 101)	2.8 scores on scale Standard Error 0.17	3.2 scores on scale Standard Error 0.18	2.9 scores on scale Standard Error 0.17	3.2 scores on scale Standard Error 0.17
Numeric Rating Scale (NRS): Average Pain Day 1 PS (n=101, 99, 101, 99)	3.4 scores on scale Standard Error 0.20	3.4 scores on scale Standard Error 0.20	2.9 scores on scale Standard Error 0.20	3.4 scores on scale Standard Error 0.20
Numeric Rating Scale (NRS): Average Pain Day 2 PS (n=102, 99, 99, 100)	2.9 scores on scale Standard Error 0.19	3.1 scores on scale Standard Error 0.19	2.9 scores on scale Standard Error 0.19	2.9 scores on scale Standard Error 0.19
Numeric Rating Scale (NRS): Average Pain Day 3 PS (n=102, 98, 98 101)	2.5 scores on scale Standard Error 0.18	2.5 scores on scale Standard Error 0.18	2.4 scores on scale Standard Error 0.18	2.5 scores on scale Standard Error 0.18
Numeric Rating Scale (NRS): Average Pain Day 4 PS (n=101, 99, 97, 100)	1.9 scores on scale Standard Error 0.17	2.0 scores on scale Standard Error 0.17	2.1 scores on scale Standard Error 0.17	1.9 scores on scale Standard Error 0.17
Numeric Rating Scale (NRS): Average Pain Day 5 PS (n=101, 99, 98, 100)	1.6 scores on scale Standard Error 0.15	1.8 scores on scale Standard Error 0.15	1.7 scores on scale Standard Error 0.15	1.8 scores on scale Standard Error 0.15
Numeric Rating Scale (NRS): Average Pain Day 6 PS (n=98, 96, 91, 96)	1.4 scores on scale Standard Error 0.14	1.5 scores on scale Standard Error 0.14	1.7 scores on scale Standard Error 0.14	1.6 scores on scale Standard Error 0.14
Numeric Rating Scale (NRS): Average Pain Day 7 PS (n=63, 66, 56, 62)	1.6 scores on scale Standard Error 0.19	1.5 scores on scale Standard Error 0.18	1.4 scores on scale Standard Error 0.20	1.3 scores on scale Standard Error 0.19

SECONDARY outcome

Timeframe: Day 1 through Day 7 post surgery

Population: MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.

Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Population: MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.

PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Population: MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)

DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep \[unable to sleep due to pain\]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Daily Sleep Interference Rating Scale (DSIRS) Score Day 2 PS (n=102, 99, 101, 101)	2.86 scores on a scale Standard Error 0.250	2.61 scores on a scale Standard Error 0.255	2.17 scores on a scale Standard Error 0.250	3.18 scores on a scale Standard Error 0.251
Daily Sleep Interference Rating Scale (DSIRS) Score Day 3 PS (n=102, 98, 100, 101)	2.13 scores on a scale Standard Error 0.211	2.01 scores on a scale Standard Error 0.216	1.50 scores on a scale Standard Error 0.213	2.11 scores on a scale Standard Error 0.212
Daily Sleep Interference Rating Scale (DSIRS) Score Day 4 PS (n=101, 99, 99, 101)	1.52 scores on a scale Standard Error 0.199	1.40 scores on a scale Standard Error 0.201	1.27 scores on a scale Standard Error 0.200	1.48 scores on a scale Standard Error 0.198
Daily Sleep Interference Rating Scale (DSIRS) Score Day 5 PS (n=101, 98, 98, 100)	1.03 scores on a scale Standard Error 0.172	1.22 scores on a scale Standard Error 0.174	1.09 scores on a scale Standard Error 0.173	1.44 scores on a scale Standard Error 0.172
Daily Sleep Interference Rating Scale (DSIRS) Score Day 6 PS (n=100, 99, 98, 99)	0.94 scores on a scale Standard Error 0.147	0.98 scores on a scale Standard Error 0.147	0.81 scores on a scale Standard Error 0.147	1.13 scores on a scale Standard Error 0.147
Daily Sleep Interference Rating Scale (DSIRS) Score Day 7 PS (n=98, 96, 92, 96)	1.04 scores on a scale Standard Error 0.150	0.90 scores on a scale Standard Error 0.151	0.72 scores on a scale Standard Error 0.154	1.00 scores on a scale Standard Error 0.150
Daily Sleep Interference Rating Scale (DSIRS) Score Day 8 PS (n=61, 65, 54, 61)	1.00 scores on a scale Standard Error 0.185	0.90 scores on a scale Standard Error 0.180	0.59 scores on a scale Standard Error 0.202	0.63 scores on a scale Standard Error 0.185
Daily Sleep Interference Rating Scale (DSIRS) Score Day 9 PS (n=21, 24, 25, 24)	0.14 scores on a scale Standard Error 0.240	1.01 scores on a scale Standard Error 0.222	0.40 scores on a scale Standard Error 0.222	1.01 scores on a scale Standard Error 0.212
Daily Sleep Interference Rating Scale (DSIRS) Score Day 10 PS (n=11, 11, 13, 11)	0.15 scores on a scale Standard Error 0.349	1.16 scores on a scale Standard Error 0.347	0.08 scores on a scale Standard Error 0.332	0.72 scores on a scale Standard Error 0.310

SECONDARY outcome

Timeframe: 24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS

Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery 24 h PS (n=102, 99, 101, 101)	10.29 mg Standard Error 2.275	9.44 mg Standard Error 2.320	6.58 mg Standard Error 2.279	16.03 mg Standard Error 2.283
Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery 48 h PS (n=102, 99, 101, 101)	13.15 mg Standard Error 2.763	14.10 mg Standard Error 2.817	9.73 mg Standard Error 2.768	19.79 mg Standard Error 2.772
Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery 72 h PS (n=102, 99, 101, 101)	14.59 mg Standard Error 3.088	16.99 mg Standard Error 3.148	12.34 mg Standard Error 3.092	22.20 mg Standard Error 3.097
Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery Day 4 PS (n=102, 99, 101, 101)	15.35 mg Standard Error 3.474	18.65 mg Standard Error 3.542	14.18 mg Standard Error 3.479	23.97 mg Standard Error 3.485
Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery Day 5 PS (n=102, 99, 101, 101)	16.09 mg Standard Error 3.786	20.46 mg Standard Error 3.860	14.64 mg Standard Error 3.792	25.57 mg Standard Error 3.798
Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery Day 6 PS (n=101, 99, 99, 100)	15.99 mg Standard Error 4.072	21.57 mg Standard Error 4.139	15.81 mg Standard Error 4.105	26.90 mg Standard Error 4.085
Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery Day 7 PS (n=99, 99, 97, 100)	15.88 mg Standard Error 4.291	22.23 mg Standard Error 4.322	16.16 mg Standard Error 4.334	28.15 mg Standard Error 4.265

SECONDARY outcome

Timeframe: End of Surgery through Day 7 post surgery

Population: MITT; data from 1 site excluded due to GCP deviations. Amount of antiemetic rescue medications not analyzed as planned.

Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study	3938.81 mg Standard Error 155.124	3930.57 mg Standard Error 155.304	3892.96 mg Standard Error 154.413	3770.07 mg Standard Error 153.322

SECONDARY outcome

Timeframe: 3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])

OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 \[none\] to 10 \[10 CMEs\]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 \[none\] to 9 \[9 CMEs\]).

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) Total CME 3 h PS (n=98, 97, 98, 98)	0.2 scores on a scale Standard Error 0.07	0.2 scores on a scale Standard Error 0.07	0.1 scores on a scale Standard Error 0.07	0.2 scores on a scale Standard Error 0.07
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) Total CME 24 h PS (n=97, 97, 98, 97)	0.2 scores on a scale Standard Error 0.07	0.3 scores on a scale Standard Error 0.07	0.4 scores on a scale Standard Error 0.07	0.2 scores on a scale Standard Error 0.07
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) Total CME 72 h PS (n=98, 96, 96, 96)	0.1 scores on a scale Standard Error 0.05	0.1 scores on a scale Standard Error 0.05	0.2 scores on a scale Standard Error 0.05	0.1 scores on a scale Standard Error 0.05
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) Total CME EOT (n=100, 98, 99, 97)	0.0 scores on a scale Standard Error 0.04	0.1 scores on a scale Standard Error 0.04	0.1 scores on a scale Standard Error 0.04	0.1 scores on a scale Standard Error 0.04
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) CT Distinct CME 3 h PS (n=98, 97, 98, 98)	0.2 scores on a scale Standard Error 0.07	0.2 scores on a scale Standard Error 0.07	0.1 scores on a scale Standard Error 0.07	0.2 scores on a scale Standard Error 0.07
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) CT Distinct CME 24 h PS (n=93, 95, 96, 94)	0.3 scores on a scale Standard Error 0.10	0.4 scores on a scale Standard Error 0.10	0.4 scores on a scale Standard Error 0.09	0.4 scores on a scale Standard Error 0.10
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) CT Distinct CME 72 h PS (n=91, 92, 93, 92)	0.3 scores on a scale Standard Error 0.11	0.5 scores on a scale Standard Error 0.11	0.5 scores on a scale Standard Error 0.11	0.5 scores on a scale Standard Error 0.11
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) CT Distinct CME EOT (n=90, 92, 93, 89)	0.3 scores on a scale Standard Error 0.11	0.5 scores on a scale Standard Error 0.11	0.6 scores on a scale Standard Error 0.11	0.6 scores on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: 3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])

Population: MITT; data from 1 site excluded due to GCP deviations.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Fatigue 3 h PS (n=99, 98, 98, 100)	4 participants	2 participants	2 participants	2 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Fatigue 24 h PS (n=99, 97, 100, 97)	2 participants	3 participants	6 participants	2 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Fatigue 72 h PS (n=101, 97, 98, 98)	0 participants	0 participants	1 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Fatigue EOT (n=100, 98, 100, 98)	0 participants	0 participants	0 participants	3 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Drowsiness 3 h PS (n=99, 98, 98, 100)	5 participants	4 participants	4 participants	4 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Drowsiness 24 h PS (n=98, 98, 99, 97)	2 participants	7 participants	8 participants	3 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Drowsiness 72 h PS (n=100, 98, 98, 98)	1 participants	0 participants	1 participants	3 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Drowsiness EOT (n=100, 98, 100, 97)	0 participants	0 participants	2 participants	3 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Inability to concentr 3 h PS (n=100, 97, 98, 99)	1 participants	0 participants	0 participants	2 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Inability to concentr 24 h PS (n=99, 98, 100, 97)	1 participants	1 participants	2 participants	2 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Inability to concentr 72 h PS (101, 98, 98, 97)	0 participants	0 participants	1 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Inability to concentr EOT (n=100, 98, 100, 99)	1 participants	0 participants	0 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Nausea 3 h PS (n=101, 97, 99, 100)	2 participants	1 participants	1 participants	4 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Nausea 24 h PS (n=100, 99, 101, 98)	3 participants	4 participants	3 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Nausea 72 h PS (n=101, 99, 99, 98)	0 participants	0 participants	0 participants	0 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Nausea EOT (n=101, 98, 100, 99)	1 participants	0 participants	2 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Dizziness 3 h PS (n=101, 97, 99, 100)	2 participants	1 participants	5 participants	6 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Dizziness 24 h PS (n=100, 98, 99, 98)	2 participants	3 participants	6 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Dizziness 72 h PS (n=101, 98, 97, 98)	0 participants	0 participants	1 participants	0 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Dizziness EOT (n=101, 98, 100, 99)	1 participants	0 participants	1 participants	0 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Constipation 3 h PS (n=101, 98, 99, 100)	1 participants	0 participants	0 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Constipation 24 h PS (n=99, 99, 100, 98)	4 participants	4 participants	7 participants	5 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Constipation 72 h PS (n=99, 97, 98, 98)	4 participants	7 participants	10 participants	7 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Constipation EOT (n=101, 98, 99, 99)	1 participants	2 participants	5 participants	2 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Itching 3 h PS (n=100, 98, 99, 100)	0 participants	1 participants	0 participants	0 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Itching 24 h PS (n=100, 99, 101, 98)	0 participants	0 participants	1 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Itching 72 h PS (n=100, 99, 99, 97)	1 participants	1 participants	0 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Itching EOT (n=101, 98, 100, 98)	0 participants	0 participants	0 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Difficulty Urinating 3 h PS (n=101, 98, 99, 99)	0 participants	3 participants	2 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Difficulty Urinating 24 h PS (n=100, 99, 100, 98)	2 participants	4 participants	5 participants	3 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Difficulty Urinating 72 h PS (n=100, 99, 99, 98)	2 participants	0 participants	3 participants	0 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Difficulty Urinating EOT (n= 101, 98, 100, 99)	1 participants	0 participants	3 participants	0 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Confusion 3 h PS (n=101, 98, 99, 100)	2 participants	3 participants	3 participants	2 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Confusion 24 h PS (n=101, 99, 99, 98)	1 participants	1 participants	2 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Confusion 72 h PS (n=100, 99, 99, 98)	2 participants	1 participants	3 participants	2 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Confusion EOT (n=101, 98, 100, 99)	0 participants	2 participants	0 participants	2 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Retching/Vomiting 3 h PS (n=101, 98, 99, 100)	0 participants	0 participants	0 participants	3 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Retching/Vomiting 24 h PS (n=101, 99, 100, 98)	0 participants	2 participants	0 participants	1 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Retching/Vomiting 72 h PS (n=101, 99, 99, 98)	0 participants	0 participants	0 participants	0 participants
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) Retching/Vomiting EOT (n=101, 98, 100, 99)	0 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: 24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])

Population: MITT; data from 1 site excluded due to GCP deviations

GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Subject Global Evaluation of Study Medication (GESM) 24 h PS: Poor (n=100, 96, 101, 99)	10 participants	8 participants	7 participants	15 participants
Subject Global Evaluation of Study Medication (GESM) 24 h PS: Fair (n=100, 96, 101, 99)	29 participants	28 participants	25 participants	32 participants
Subject Global Evaluation of Study Medication (GESM) 24 h PS: Good (n=100, 96, 101, 99)	45 participants	46 participants	42 participants	40 participants
Subject Global Evaluation of Study Medication (GESM) 24 h PS: Excellent (n=100, 96, 101, 99)	16 participants	14 participants	27 participants	12 participants
Subject Global Evaluation of Study Medication (GESM) EOT: Poor (n=99, 99, 100, 100)	9 participants	10 participants	6 participants	18 participants
Subject Global Evaluation of Study Medication (GESM) EOT: Fair (n=99, 99, 100, 100)	14 participants	19 participants	14 participants	19 participants
Subject Global Evaluation of Study Medication (GESM) EOT: Good (n=99, 99, 100, 100)	45 participants	37 participants	30 participants	32 participants
Subject Global Evaluation of Study Medication (GESM) EOT: Excellent (n=99, 99, 100, 100)	31 participants	33 participants	50 participants	31 participants

SECONDARY outcome

Timeframe: Day 7 post surgery (PS) and up to 30 days PS

Population: Operated subjects within the safety population. Safety population=all randomized subjects administered at least 1 dose of study drug and for whom at least 1 post-baseline safety evaluation was obtained.

Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=106 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=104 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=102 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=106 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Participants With Wound Healing Complications No surgical wound complication	102 participants	102 participants	99 participants	101 participants
Participants With Wound Healing Complications Superficial incisional surgical site infection	1 participants	0 participants	1 participants	1 participants
Participants With Wound Healing Complications Deep incisional surgical site infection	0 participants	0 participants	0 participants	0 participants
Participants With Wound Healing Complications Organ/space surgical site infection	0 participants	0 participants	0 participants	0 participants
Participants With Wound Healing Complications Non-infectious wound healing complication	2 participants	1 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: 24 and 72 hours (h) post surgery (PS)

Population: MITT; data from 1 site excluded due to GCP deviations

Number of participants who answered "yes" to the Post-Surgery Contact question: "From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?"

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Participants With Physician Contacts Post-discharge 24 h PS	0 participants	2 participants	1 participants	0 participants
Participants With Physician Contacts Post-discharge 72 h PS	1 participants	3 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS

Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject's mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score Day 5 PS (n=101, 98, 97, 99)	-12.3 scores on a scale Standard Error 1.06	-15.0 scores on a scale Standard Error 1.07	-12.4 scores on a scale Standard Error 1.06	-12.7 scores on a scale Standard Error 1.07
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score Baseline (n=101, 98, 100, 100)	20.2 scores on a scale Standard Error 2.07	19.4 scores on a scale Standard Error 2.10	18.4 scores on a scale Standard Error 2.07	16.4 scores on a scale Standard Error 2.07
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score 2 h BS (n=101, 98, 100, 99)	0.2 scores on a scale Standard Error 1.56	3.2 scores on a scale Standard Error 1.58	1.4 scores on a scale Standard Error 1.54	4.2 scores on a scale Standard Error 1.57
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score 1 h PS (n=100, 96, 99, 99)	-6.4 scores on a scale Standard Error 1.71	-3.5 scores on a scale Standard Error 1.73	-5.2 scores on a scale Standard Error 1.68	-3.2 scores on a scale Standard Error 1.70
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score 2 h PS (n=101, 98, 100, 100)	-8.4 scores on a scale Standard Error 1.51	-7.6 scores on a scale Standard Error 1.52	-7.1 scores on a scale Standard Error 1.48	-6.1 scores on a scale Standard Error 1.50
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score 3 h PS (n=101, 98, 100, 100)	-8.7 scores on a scale Standard Error 1.44	-8.3 scores on a scale Standard Error 1.45	-9.0 scores on a scale Standard Error 1.42	-6.4 scores on a scale Standard Error 1.43
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score Day 2 PS (n=101, 98, 100, 100)	-7.9 scores on a scale Standard Error 1.59	-10.4 scores on a scale Standard Error 1.60	-7.5 scores on a scale Standard Error 1.56	-5.8 scores on a scale Standard Error 1.58
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score Day 3 PS (n=101, 97, 99, 100)	-9.1 scores on a scale Standard Error 1.23	-12.7 scores on a scale Standard Error 1.25	-11.3 scores on a scale Standard Error 1.22	-9.3 scores on a scale Standard Error 1.23
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score Day 4 PS (n=101, 98, 98, 101)	-11.1 scores on a scale Standard Error 1.23	-15.3 scores on a scale Standard Error 1.24	-12.1 scores on a scale Standard Error 1.23	-11.4 scores on a scale Standard Error 1.22
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score Day 6 PS (n=100, 98, 97, 97)	-12.5 scores on a scale Standard Error 1.08	-15.0 scores on a scale Standard Error 1.08	-13.6 scores on a scale Standard Error 1.07	-12.8 scores on a scale Standard Error 1.09
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score Day 7 PS (n=97, 93, 89, 95)	-13.0 scores on a scale Standard Error 1.15	-15.2 scores on a scale Standard Error 1.16	-13.3 scores on a scale Standard Error 1.19	-12.4 scores on a scale Standard Error 1.15
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score Day 8 PS (n=61, 64, 53, 58)	-13.6 scores on a scale Standard Error 1.16	-15.4 scores on a scale Standard Error 1.11	-15.5 scores on a scale Standard Error 1.25	-14.7 scores on a scale Standard Error 1.18
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score Day 9 PS (n=21, 24, 23, 22)	-16.6 scores on a scale Standard Error 2.07	-16.4 scores on a scale Standard Error 1.90	-14.7 scores on a scale Standard Error 1.97	-12.8 scores on a scale Standard Error 1.90

SECONDARY outcome

Timeframe: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])

Population: MITT; data from 1 site excluded due to GCP deviations.

EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score Baseline (n=101, 99, 100, 100)	0.66 scores on scales Standard Error 0.015	0.68 scores on scales Standard Error 0.015	0.65 scores on scales Standard Error 0.015	0.66 scores on scales Standard Error 0.015
Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score Change at EOT (n=97, 98, 99, 98)	-0.01 scores on scales Standard Error 0.016	-0.01 scores on scales Standard Error 0.016	-0.01 scores on scales Standard Error 0.015	-0.04 scores on scales Standard Error 0.016

SECONDARY outcome

Timeframe: 3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])

The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales Total score change: 3 h PS (n=99, 98, 98, 99)	-3.5 scores on a scale Standard Error 0.84	-2.8 scores on a scale Standard Error 0.85	-3.6 scores on a scale Standard Error 0.83	-1.5 scores on a scale Standard Error 0.84
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales Total score change: EOT (n=97, 96, 98, 96)	-6.2 scores on a scale Standard Error 0.64	-5.8 scores on a scale Standard Error 0.64	-6.3 scores on a scale Standard Error 0.63	-5.7 scores on a scale Standard Error 0.64
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales Rumination change: 3 h PS (n=99, 98, 98, 99)	-1.0 scores on a scale Standard Error 0.35	-0.7 scores on a scale Standard Error 0.35	-1.1 scores on a scale Standard Error 0.35	-0.4 scores on a scale Standard Error 0.35
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales Rumination change: EOT (n=97, 96, 98, 96)	-2.3 scores on a scale Standard Error 0.28	-1.8 scores on a scale Standard Error 0.28	-2.2 scores on a scale Standard Error 0.27	-1.9 scores on a scale Standard Error 0.28
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales Magnification change: 3 h PS (n=99, 98, 99, 99)	-0.9 scores on a scale Standard Error 0.21	-0.9 scores on a scale Standard Error 0.21	-1.1 scores on a scale Standard Error 0.21	-0.7 scores on a scale Standard Error 0.21
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales Magnification change: EOT (n=97, 96, 99, 96)	-1.5 scores on a scale Standard Error 0.17	-1.7 scores on a scale Standard Error 0.17	-1.6 scores on a scale Standard Error 0.17	-1.4 scores on a scale Standard Error 0.17
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales Helplessness change: 3 h PS (n=99, 98, 99, 99)	-1.5 scores on a scale Standard Error 0.37	-1.3 scores on a scale Standard Error 0.38	-1.4 scores on a scale Standard Error 0.37	-0.5 scores on a scale Standard Error 0.37
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales Helplessness change: EOT (n=97, 96, 99, 96)	-2.4 scores on a scale Standard Error 0.27	-2.3 scores on a scale Standard Error 0.27	-2.5 scores on a scale Standard Error 0.26	-2.5 scores on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: Baseline and Days 1 and 7 post surgery (PS)

Population: MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])

Population: MITT; data from 1 site excluded due to GCP deviations.

PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) PCSS at baseline (n=101, 99, 100, 100)	46.43 scores on a scale Standard Error 0.914	48.14 scores on a scale Standard Error 0.928	46.44 scores on a scale Standard Error 0.915	44.89 scores on a scale Standard Error 0.917
Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) PCSS change at EOT (n=99, 99, 99, 98)	-6.86 scores on a scale Standard Error 1.013	-7.06 scores on a scale Standard Error 1.021	-6.92 scores on a scale Standard Error 1.011	-8.21 scores on a scale Standard Error 1.025
Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) MCSS at baseline (n=101, 99, 100, 100)	54.48 scores on a scale Standard Error 0.787	54.58 scores on a scale Standard Error 0.799	54.81 scores on a scale Standard Error 0.787	56.18 scores on a scale Standard Error 0.789
Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) MCSS change at EOT (n=99, 99, 99, 98)	2.65 scores on a scale Standard Error 0.764	2.68 scores on a scale Standard Error 0.762	3.27 scores on a scale Standard Error 0.750	1.50 scores on a scale Standard Error 0.765

SECONDARY outcome

Timeframe: 1, 3, and 6 months (mo) post surgery (PS)

Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: "In the last 24 hours, have you had pain in the area affected by your surgery?")

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Participants With Chronic Postoperative Pain 1 month PS (n=98, 98, 98, 99)	20 participants	24 participants	19 participants	26 participants
Participants With Chronic Postoperative Pain 3 month PS (n=98, 97, 97, 97)	3 participants	5 participants	5 participants	3 participants
Participants With Chronic Postoperative Pain 6 month PS (n=98, 97, 97, 97)	1 participants	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 1, 3, and 6 months (mo) post surgery (PS)

Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.

m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain).

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) Pain Severity 1 mo PS (n=20, 24, 19, 26)	0.86 scores on a scale Standard Deviation 0.801	0.81 scores on a scale Standard Deviation 0.767	1.43 scores on a scale Standard Deviation 1.210	0.76 scores on a scale Standard Deviation 0.654
Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) Pain Severity 3 mo PS (n=3, 5, 5, 3)	0.58 scores on a scale Standard Deviation 0.629	0.75 scores on a scale Standard Deviation 0.354	1.55 scores on a scale Standard Deviation 1.052	0.42 scores on a scale Standard Deviation 0.520
Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) Pain Interference 1 mo PS (n=20, 24, 19, 26)	0.39 scores on a scale Standard Deviation 0.630	0.71 scores on a scale Standard Deviation 0.974	1.29 scores on a scale Standard Deviation 1.463	0.51 scores on a scale Standard Deviation 0.895
Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) Pain Interference 3 mo PS (n=3, 5, 5, 3)	0.14 scores on a scale Standard Deviation 0.143	0.20 scores on a scale Standard Deviation 0.163	1.34 scores on a scale Standard Deviation 2.140	0.00 scores on a scale Standard Deviation 0.000

SECONDARY outcome

Timeframe: 1, 3, and 6 months (mo) post surgery (PS)

NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 \[no pain\] to 10 \[worst pain imaginable\]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain.

Outcome measures

Outcome measures
Measure	Pregabalin 50 mg n=102 Participants Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=99 Participants Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=101 Participants Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=101 Participants Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) Paroxysmal pain 3 mo PS (n=3, 5, 5, 3)	0.33 scores on a scale Standard Deviation 0.289	0.20 scores on a scale Standard Deviation 0.274	0.70 scores on a scale Standard Deviation 0.447	1.33 scores on a scale Standard Deviation 1.528
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) Evoked pain 1 mo PS (n=20, 24, 19, 26)	0.82 scores on a scale Standard Deviation 0.970	0.76 scores on a scale Standard Deviation 0.990	1.44 scores on a scale Standard Deviation 1.495	1.05 scores on a scale Standard Deviation 1.472
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) Evoked pain 3 mo PS (n=3, 5, 5, 3)	0.22 scores on a scale Standard Deviation 0.192	1.3 scores on a scale Standard Deviation 2.082	1.73 scores on a scale Standard Deviation 1.234	0.44 scores on a scale Standard Deviation 0.509
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) Paresth/dysesth 1 mo PS (n=20, 24, 19, 26)	0.10 scores on a scale Standard Deviation 0.308	0.35 scores on a scale Standard Deviation 0.961	0.32 scores on a scale Standard Deviation 0.768	0.46 scores on a scale Standard Deviation 0.774
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) Paresth/dysesth 3 mo PS (n=3, 5, 5, 3)	0.50 scores on a scale Standard Deviation 0.866	0.20 scores on a scale Standard Deviation 0.274	0.10 scores on a scale Standard Deviation 0.224	0.50 scores on a scale Standard Deviation 0.866
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) NPSI total score 1 mo PS (n=20, 24, 19, 26)	0.03 scores on a scale Standard Deviation 0.025	0.03 scores on a scale Standard Deviation 0.048	0.05 scores on a scale Standard Deviation 0.038	0.04 scores on a scale Standard Deviation 0.041
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) NPSI total score 3 mo PS (n=3, 5, 5, 3)	0.02 scores on a scale Standard Deviation 0.032	0.02 scores on a scale Standard Deviation 0.022	0.05 scores on a scale Standard Deviation 0.034	0.04 scores on a scale Standard Deviation 0.044
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) Burning spont. pain 1 mo PS (n=20, 24, 19, 26)	0.30 scores on a scale Standard Deviation 0.571	1.04 scores on a scale Standard Deviation 1.574	1.11 scores on a scale Standard Deviation 1.761	0.77 scores on a scale Standard Deviation 1.557
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) Burning spont. pain 3 mo PS (n=3, 5, 5, 3)	1.00 scores on a scale Standard Deviation 1.732	0.00 scores on a scale Standard Deviation 0.00	0.40 scores on a scale Standard Deviation 0.894	1.00 scores on a scale Standard Deviation 1.732
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) Pressing spont. pain 1 mo PS (n=20, 24, 19, 26)	0.43 scores on a scale Standard Deviation 0.545	0.50 scores on a scale Standard Deviation 1.189	1.03 scores on a scale Standard Deviation 1.307	0.69 scores on a scale Standard Deviation 0.939
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) Pressing spont. pain 3 mo PS (n=3, 5, 5, 3)	0.50 scores on a scale Standard Deviation 0.500	0.50 scores on a scale Standard Deviation 0.354	2.30 scores on a scale Standard Deviation 1.754	0.67 scores on a scale Standard Deviation 0.764
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) Paroxysmal pain 1 mo PS (n=20, 24, 19, 26)	0.95 scores on a scale Standard Deviation 1.708	0.56 scores on a scale Standard Deviation 1.106	1.05 scores on a scale Standard Deviation 1.499	0.71 scores on a scale Standard Deviation 1.133

Adverse Events

Pregabalin 50 mg

Serious events: 3 serious events

Other events: 46 other events

Deaths: 0 deaths

Pregabalin 150 mg

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Pregabalin 300 mg

Serious events: 0 serious events

Other events: 56 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pregabalin 50 mg n=108 participants at risk Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	Pregabalin 150 mg n=106 participants at risk Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	Pregabalin 300 mg n=103 participants at risk Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	Placebo n=108 participants at risk Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
Gastrointestinal disorders Abdominal pain	0.00% 0/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/106 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.93% 1/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.93% 1/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/106 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/106 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.93% 1/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.00% 0/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/106 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.93% 1/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.93% 1/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/106 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Amnesia	0.00% 0/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.94% 1/106 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Guillain-Barre syndrome	0.93% 1/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/106 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Haematoma	0.00% 0/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/106 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.93% 1/108 • Baseline (Day 0) through post-treatment phone contact (Month 6) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER