Trial Outcomes & Findings for Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy (NCT NCT00468845)

Results Overview

Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

501 participants

Primary outcome timeframe

Day 2 (24 hours post surgery [PS])

Results posted on

2021-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Pregabalin 150mg Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg Pregabalin 150 mg twice a day (300 mg/day total)	Placebo Matching placebo capsule
Overall Study STARTED	162	170	169
Overall Study Received Treatment	161	166	167
Overall Study COMPLETED	141	136	139
Overall Study NOT COMPLETED	21	34	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin 150mg Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg Pregabalin 150 mg twice a day (300 mg/day total)	Placebo Matching placebo capsule
Overall Study Adverse Event	9	14	11
Overall Study Lost to Follow-up	2	1	2
Overall Study Other	4	9	5
Overall Study No longer willing to participate	5	6	10
Overall Study Randomized, not treated	1	4	2

Baseline Characteristics

Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin 150mg n=162 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=170 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=169 Participants Matching placebo capsule	Total n=501 Participants Total of all reporting groups
Age, Customized 25-44 years	77 participants n=5 Participants	76 participants n=7 Participants	88 participants n=5 Participants	241 participants n=4 Participants
Age, Customized 45-70 years	84 participants n=5 Participants	90 participants n=7 Participants	79 participants n=5 Participants	253 participants n=4 Participants
Age, Customized Unspecified	1 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	7 participants n=4 Participants
Sex: Female, Male Female	162 Participants n=5 Participants	170 Participants n=7 Participants	169 Participants n=5 Participants	501 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 2 (24 hours post surgery [PS])

Population: Modified intent-to-treat (mITT) population: participants who received at least 1 dose study drug, had at least 1 post baseline safety and efficacy evaluation, took all pre-surgery medication, had no complications during surgery with discontinuation, no PS infection with additional hospitalization/readmission, had primary efficacy measurement PS

Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=151 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=149 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=156 Participants Matching placebo capsule
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)	7.1 Units on a scale Standard Error 0.18	7.2 Units on a scale Standard Error 0.18	7.4 Units on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.

Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=147 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=141 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=149 Participants Matching placebo capsule
Current Pain - Pain With Movement Caused by Sitting 96 Hours PS (n=29, 31, 26)	2.31 Units on a scale Standard Error 0.425	3.20 Units on a scale Standard Error 0.383	3.20 Units on a scale Standard Error 0.444
Current Pain - Pain With Movement Caused by Sitting 120 Hours PS (n=14, 15, 12)	2.89 Units on a scale Standard Error 0.584	2.84 Units on a scale Standard Error 0.527	2.36 Units on a scale Standard Error 0.633
Current Pain - Pain With Movement Caused by Sitting 144 Hours PS (n=2, 5, 5)	1.86 Units on a scale Standard Error 1.496	1.26 Units on a scale Standard Error 1.177	2.00 Units on a scale Standard Error 1.010
Current Pain - Pain With Movement Caused by Sitting Discharge (n=141, 135, 144)	2.67 Units on a scale Standard Error 0.175	2.99 Units on a scale Standard Error 0.181	2.42 Units on a scale Standard Error 0.176
Current Pain - Pain With Movement Caused by Sitting Day 14 (n=126, 120, 128)	1.08 Units on a scale Standard Error 0.140	1.37 Units on a scale Standard Error 0.145	1.30 Units on a scale Standard Error 0.143
Current Pain - Pain With Movement Caused by Sitting Day 28 (n=138, 138, 142)	0.70 Units on a scale Standard Error 0.126	0.91 Units on a scale Standard Error 0.129	0.76 Units on a scale Standard Error 0.127
Current Pain - Pain With Movement Caused by Sitting 24 Hours PS (n=147, 141, 149)	5.21 Units on a scale Standard Error 0.188	5.53 Units on a scale Standard Error 0.194	5.28 Units on a scale Standard Error 0.189
Current Pain - Pain With Movement Caused by Sitting 48 Hours PS (n=142, 141, 142)	3.57 Units on a scale Standard Error 0.185	3.71 Units on a scale Standard Error 0.189	3.67 Units on a scale Standard Error 0.189
Current Pain - Pain With Movement Caused by Sitting 72 Hours PS (n=83, 90, 75)	2.80 Units on a scale Standard Error 0.239	3.04 Units on a scale Standard Error 0.225	3.20 Units on a scale Standard Error 0.257

SECONDARY outcome

Timeframe: Day 1, up to 7 days PS, 2 and 4 weeks PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.

Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=146 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=143 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=148 Participants Matching placebo capsule
Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test 24 hours PS (n=146, 142, 148)	4.83 Units on a scale Standard Error 0.202	4.92 Units on a scale Standard Error 0.209	4.97 Units on a scale Standard Error 0.207
Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test 48 hours PS (n=141, 143, 140)	3.22 Units on a scale Standard Error 0.204	3.47 Units on a scale Standard Error 0.205	3.46 Units on a scale Standard Error 0.210
Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test 72 hours PS (n=83, 90, 74)	2.62 Units on a scale Standard Error 0.242	2.69 Units on a scale Standard Error 0.228	3.04 Units on a scale Standard Error 0.263
Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test 96 hours PS (n=28, 31, 25)	1.88 Units on a scale Standard Error 0.465	3.05 Units on a scale Standard Error 0.414	3.28 Units on a scale Standard Error 0.487
Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test 120 hours PS (n=13, 14, 11)	1.97 Units on a scale Standard Error 0.685	2.10 Units on a scale Standard Error 0.609	1.45 Units on a scale Standard Error 0.740
Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test 144 hours PS (n=2, 5, 3)	3.67 Units on a scale Standard Error 2.472	0.67 Units on a scale Standard Error 1.453	1.67 Units on a scale Standard Error 1.764

SECONDARY outcome

Timeframe: 48 +/- 4 hours PS

Population: mITT; N=number of evaluable participants analyzed

Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=147 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=140 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=150 Participants Matching placebo capsule
Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting	4.87 Units on a scale Standard Error 0.155	5.01 Units on a scale Standard Error 0.161	4.87 Units on a scale Standard Error 0.157

SECONDARY outcome

Timeframe: 48 +/- 4 hours PS

Population: mITT; N=number of evaluable participants analyzed

Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=148 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=142 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=146 Participants Matching placebo capsule
Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test	4.45 Units on a scale Standard Error 0.167	4.64 Units on a scale Standard Error 0.174	4.61 Units on a scale Standard Error 0.173

SECONDARY outcome

Timeframe: 8, 16, 24, 32, 40, 48 hours PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Pain reported by participants at rest (numeric rating scale (NRS) - Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=151 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=147 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=154 Participants Matching placebo capsule
Current Pain at Rest 8 Hours PS (n=123, 125, 126)	5.13 Units on a scale Standard Error 0.232	5.39 Units on a scale Standard Error 0.231	5.47 Units on a scale Standard Error 0.225
Current Pain at Rest 16 Hours PS (n=94, 88, 107)	4.06 Units on a scale Standard Error 0.256	4.55 Units on a scale Standard Error 0.273	4.30 Units on a scale Standard Error 0.245
Current Pain at Rest 24 Hours PS (n=151, 147, 154)	3.79 Units on a scale Standard Error 0.179	3.76 Units on a scale Standard Error 0.184	3.93 Units on a scale Standard Error 0.180
Current Pain at Rest 32 Hours PS (n=127, 127, 136)	3.37 Units on a scale Standard Error 0.207	3.31 Units on a scale Standard Error 0.212	3.55 Units on a scale Standard Error 0.204
Current Pain at Rest 40 Hours PS (n=93, 97, 100)	2.97 Units on a scale Standard Error 0.265	2.71 Units on a scale Standard Error 0.265	2.98 Units on a scale Standard Error 0.263
Current Pain at Rest 48 Hours PS (n=142, 143, 140)	2.60 Units on a scale Standard Error 0.173	2.26 Units on a scale Standard Error 0.174	2.65 Units on a scale Standard Error 0.179

SECONDARY outcome

Timeframe: 48 +/- 4 hours PS

Population: mITT; N=number of evaluable participants analyzed

Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=151 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=147 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=154 Participants Matching placebo capsule
Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay	3.62 Units on a scale Standard Error 0.143	3.58 Units on a scale Standard Error 0.147	3.76 Units on a scale Standard Error 0.144

SECONDARY outcome

Timeframe: 24, 48 Hours PS, Discharge (day 3 up to day 7 PS)

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=150 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=147 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=153 Participants Matching placebo capsule
Total Cumulative Dose of Opioids Following Surgery 24 hours PS (n=150, 147, 153)	113.38 milligram (mg) Standard Error 7.078	111.27 milligram (mg) Standard Error 7.211	124.44 milligram (mg) Standard Error 7.160
Total Cumulative Dose of Opioids Following Surgery 48 hours PS (n=150, 147, 151)	148.67 milligram (mg) Standard Error 9.218	144.95 milligram (mg) Standard Error 9.391	168.31 milligram (mg) Standard Error 9.372
Total Cumulative Dose of Opioids Following Surgery Till Discharge (n=147, 143, 144)	164.28 milligram (mg) Standard Error 11.161	167.01 milligram (mg) Standard Error 11.410	195.32 milligram (mg) Standard Error 11.569

SECONDARY outcome

Timeframe: 0-24, 24-48, 48-72 hours PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=150 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=145 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=151 Participants Matching placebo capsule
Integrated Analgesic Score 0-24 Hours PS (n=150, 145, 151)	-6.58 Units on a scale Standard Error 6.795	-11.66 Units on a scale Standard Error 6.991	3.36 Units on a scale Standard Error 6.906
Integrated Analgesic Score 24-48 Hours PS (n=141, 142, 139)	-5.51 Units on a scale Standard Error 6.979	-18.84 Units on a scale Standard Error 7.051	5.48 Units on a scale Standard Error 7.210
Integrated Analgesic Score 48-72 Hours PS (n=81, 89, 74)	3.23 Units on a scale Standard Error 9.884	-6.93 Units on a scale Standard Error 9.271	19.85 Units on a scale Standard Error 10.568

SECONDARY outcome

Timeframe: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=150 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=147 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=155 Participants Matching placebo capsule
Non-opioid Rescue Medication - Paracetamol 24 Hours PS (n=150, 147, 155)	1.16 Grams (g) Standard Deviation 0.098	1.21 Grams (g) Standard Deviation 0.100	1.22 Grams (g) Standard Deviation 0.098
Non-opioid Rescue Medication - Paracetamol 48 Hours PS (n=150, 147, 154)	3.23 Grams (g) Standard Deviation 0.195	3.20 Grams (g) Standard Deviation 0.199	3.55 Grams (g) Standard Deviation 0.195
Non-opioid Rescue Medication - Paracetamol 72 Hours PS (n=150, 147,149)	5.07 Grams (g) Standard Deviation 0.294	5.08 Grams (g) Standard Deviation 0.300	5.68 Grams (g) Standard Deviation 0.301
Non-opioid Rescue Medication - Paracetamol 1st Week PS (n=142, 142, 145)	10.76 Grams (g) Standard Deviation 0.732	10.57 Grams (g) Standard Deviation 0.739	12.63 Grams (g) Standard Deviation 0.740
Non-opioid Rescue Medication - Paracetamol 2nd Week PS (n=139, 135, 143)	17.89 Grams (g) Standard Deviation 1.711	16.79 Grams (g) Standard Deviation 1.747	19.70 Grams (g) Standard Deviation 1.731
Non-opioid Rescue Medication - Paracetamol 3rd Week PS (n=131, 124, 134)	23.56 Grams (g) Standard Deviation 2.654	22.12 Grams (g) Standard Deviation 2.748	24.35 Grams (g) Standard Deviation 2.695
Non-opioid Rescue Medication - Paracetamol 4th Week PS (n=95, 94, 103)	27.10 Grams (g) Standard Deviation 3.313	25.62 Grams (g) Standard Deviation 3.437	25.63 Grams (g) Standard Deviation 3.301
Non-opioid Rescue Medication - Paracetamol Till Discharge (n=147, 143, 147)	5.45 Grams (g) Standard Deviation 0.390	5.78 Grams (g) Standard Deviation 0.399	6.05 Grams (g) Standard Deviation 0.399

SECONDARY outcome

Timeframe: Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=150 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=149 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=154 Participants Matching placebo capsule
Anxiety Before and After Surgery Surgery Day (prior to first dose)(n=149, 144, 151)	31.9 Units on a scale Standard Error 2.38	28.4 Units on a scale Standard Error 2.45	33.3 Units on a scale Standard Error 2.40
Anxiety Before and After Surgery Surgery Day (1 hour after dosing)(n=138, 139, 146)	29.5 Units on a scale Standard Error 2.39	29.7 Units on a scale Standard Error 2.39	30.9 Units on a scale Standard Error 2.38
Anxiety Before and After Surgery Day 1 PS (n=150, 149, 154)	15.6 Units on a scale Standard Error 1.75	16.1 Units on a scale Standard Error 1.78	18.6 Units on a scale Standard Error 1.77
Anxiety Before and After Surgery Day 2 PS (n=112, 120, 118)	12.6 Units on a scale Standard Error 2.05	13.4 Units on a scale Standard Error 1.98	13.8 Units on a scale Standard Error 2.03
Anxiety Before and After Surgery Day 3 PS (n=44, 40, 35)	17.2 Units on a scale Standard Error 3.17	11.2 Units on a scale Standard Error 2.93	13.9 Units on a scale Standard Error 3.20
Anxiety Before and After Surgery Day 4 PS (n=17, 20, 15)	9.0 Units on a scale Standard Error 3.22	4.2 Units on a scale Standard Error 2.72	9.3 Units on a scale Standard Error 3.51
Anxiety Before and After Surgery Day 5 PS (n=7, 13, 7)	11.6 Units on a scale Standard Error 8.31	4.5 Units on a scale Standard Error 5.39	15.1 Units on a scale Standard Error 8.46
Anxiety Before and After Surgery Discharge (n=143, 144, 148)	10.2 Units on a scale Standard Error 1.50	8.3 Units on a scale Standard Error 1.50	8.8 Units on a scale Standard Error 1.50

SECONDARY outcome

Timeframe: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=150 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=147 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=155 Participants Matching placebo capsule
Non-opioid Rescue Medication - Ibuprofen 2nd Week PS (n=140, 135, 143)	1.22 Grams (g) Standard Deviation 0.413	1.94 Grams (g) Standard Deviation 0.423	1.88 Grams (g) Standard Deviation 0.420
Non-opioid Rescue Medication - Ibuprofen 3rd Week PS (n=132, 124, 134)	1.95 Grams (g) Standard Deviation 0.665	2.99 Grams (g) Standard Deviation 0.692	2.83 Grams (g) Standard Deviation 0.679
Non-opioid Rescue Medication - Ibuprofen 4th Week PS (n=95, 94, 103)	2.42 Grams (g) Standard Deviation 1.041	4.30 Grams (g) Standard Deviation 1.080	3.84 Grams (g) Standard Deviation 1.038
Non-opioid Rescue Medication - Ibuprofen Till Discharge (n=147, 143, 147)	0.18 Grams (g) Standard Deviation 0.074	0.38 Grams (g) Standard Deviation 0.076	0.26 Grams (g) Standard Deviation 0.076
Non-opioid Rescue Medication - Ibuprofen 24 Hours PS (n=150, 147, 155)	0.01 Grams (g) Standard Deviation 0.014	0.03 Grams (g) Standard Deviation 0.014	0.01 Grams (g) Standard Deviation 0.014
Non-opioid Rescue Medication - Ibuprofen 48 Hours PS (n=150, 147, 154)	0.08 Grams (g) Standard Deviation 0.037	0.15 Grams (g) Standard Deviation 0.038	0.12 Grams (g) Standard Deviation 0.038
Non-opioid Rescue Medication - Ibuprofen 72 Hours PS (n=150, 147, 149)	0.14 Grams (g) Standard Deviation 0.064	0.27 Grams (g) Standard Deviation 0.065	0.24 Grams (g) Standard Deviation 0.066
Non-opioid Rescue Medication - Ibuprofen 1st Week PS (n=142, 142, 145)	0.51 Grams (g) Standard Deviation 0.208	0.87 Grams (g) Standard Deviation 0.210	0.97 Grams (g) Standard Deviation 0.211

SECONDARY outcome

Timeframe: Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.

Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=116 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=114 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=121 Participants Matching placebo capsule
Percent Change From Baseline in Peak Expiratory Flow Baseline (n=116, 114, 121)	0 L/min Standard Error 0	0 L/min Standard Error 0	0 L/min Standard Error 0
Percent Change From Baseline in Peak Expiratory Flow 8 Hours PS (n=84, 79, 83)	-39.25 L/min Standard Error 3.081	-35.35 L/min Standard Error 3.307	-41.29 L/min Standard Error 3.242
Percent Change From Baseline in Peak Expiratory Flow 16 Hours PS (n=72, 62, 76)	-37.37 L/min Standard Error 3.454	-36.49 L/min Standard Error 3.764	-36.48 L/min Standard Error 3.395
Percent Change From Baseline in Peak Expiratory Flow 24 Hours PS (n=115, 112, 117)	-28.92 L/min Standard Error 3.084	-26.53 L/min Standard Error 3.212	-29.46 L/min Standard Error 3.058
Percent Change From Baseline in Peak Expiratory Flow 32 Hours PS (n=104, 105, 106)	-24.53 L/min Standard Error 3.510	-25.66 L/min Standard Error 3.644	-28.92 L/min Standard Error 3.632
Percent Change From Baseline in Peak Expiratory Flow 40 Hours PS (n=70, 73, 79)	-24.18 L/min Standard Error 3.575	-25.70 L/min Standard Error 3.663	-25.07 L/min Standard Error 3.449
Percent Change From Baseline in Peak Expiratory Flow 48 Hours PS (n=108, 112, 111)	-16.71 L/min Standard Error 3.203	-13.62 L/min Standard Error 3.255	-21.70 L/min Standard Error 3.162
Percent Change From Baseline in Peak Expiratory Flow 56 Hours PS (n=78, 85, 82)	-17.11 L/min Standard Error 3.760	-15.40 L/min Standard Error 3.771	-21.12 L/min Standard Error 3.726
Percent Change From Baseline in Peak Expiratory Flow 64 Hours PS (n=52, 51, 54)	-15.04 L/min Standard Error 4.672	-14.20 L/min Standard Error 5.028	-17.18 L/min Standard Error 4.392
Percent Change From Baseline in Peak Expiratory Flow 72 Hours PS (n=61, 68, 60)	-18.12 L/min Standard Error 5.270	-12.97 L/min Standard Error 4.792	-20.81 L/min Standard Error 5.059
Percent Change From Baseline in Peak Expiratory Flow 80 Hours PS (n=30, 24, 24)	-17.23 L/min Standard Error 7.290	-3.01 L/min Standard Error 7.750	-8.17 L/min Standard Error 7.443
Percent Change From Baseline in Peak Expiratory Flow 88 Hours PS (n=18, 15, 19)	-10.08 L/min Standard Error 8.257	-2.30 L/min Standard Error 8.818	-9.71 L/min Standard Error 6.636
Percent Change From Baseline in Peak Expiratory Flow 96 Hours PS (n=20, 22, 21)	-1.45 L/min Standard Error 9.063	5.26 L/min Standard Error 8.585	2.36 L/min Standard Error 9.110
Percent Change From Baseline in Peak Expiratory Flow 104 Hours PS (n=9, 12, 12)	-12.79 L/min Standard Error 10.574	0.69 L/min Standard Error 9.428	-4.94 L/min Standard Error 10.210
Percent Change From Baseline in Peak Expiratory Flow 112 Hours PS (n=5, 10, 9)	-15.61 L/min Standard Error 15.629	8.49 L/min Standard Error 10.863	-11.61 L/min Standard Error 10.700
Percent Change From Baseline in Peak Expiratory Flow 120 Hours PS (n=10, 12, 10)	-12.36 L/min Standard Error 11.386	-8.14 L/min Standard Error 10.307	-6.98 L/min Standard Error 12.201
Percent Change From Baseline in Peak Expiratory Flow 128 Hours PS (n=4, 9, 7)	-6.72 L/min Standard Error 13.735	-4.76 L/min Standard Error 8.166	-14.32 L/min Standard Error 10.711

SECONDARY outcome

Timeframe: Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=130 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=134 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=134 Participants Matching placebo capsule
Timed Up-and-Go (TUG) Day 5 PS (n=7, 10, 7)	31.27 Seconds Standard Error 5.295	23.06 Seconds Standard Error 3.704	32.18 Seconds Standard Error 5.326
Timed Up-and-Go (TUG) Discharge (n=130, 134, 134)	28.11 Seconds Standard Error 1.604	30.05 Seconds Standard Error 1.569	26.40 Seconds Standard Error 1.582
Timed Up-and-Go (TUG) Day 1 PS (n=85, 85, 93)	39.77 Seconds Standard Error 2.558	42.79 Seconds Standard Error 2.769	38.54 Seconds Standard Error 2.611
Timed Up-and-Go (TUG) Day 2 PS (n=107, 105, 105)	31.82 Seconds Standard Error 1.776	33.06 Seconds Standard Error 1.878	29.25 Seconds Standard Error 1.845
Timed Up-and-Go (TUG) Day 3 PS (n=43, 35, 31)	34.07 Seconds Standard Error 2.779	33.48 Seconds Standard Error 2.781	31.38 Seconds Standard Error 2.960
Timed Up-and-Go (TUG) Day 4 PS (n=16, 18, 13)	42.26 Seconds Standard Error 4.591	37.31 Seconds Standard Error 4.065	40.43 Seconds Standard Error 5.275

SECONDARY outcome

Timeframe: Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=134 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=131 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=139 Participants Matching placebo capsule
Average Daily Pain Day 2 PS (n=29, 21, 25)	3.9 Units on a scale Standard Error 0.48	4.3 Units on a scale Standard Error 0.55	3.1 Units on a scale Standard Error 0.59
Average Daily Pain Day 3 PS (n=97, 94, 98)	3.0 Units on a scale Standard Error 0.22	3.2 Units on a scale Standard Error 0.23	2.8 Units on a scale Standard Error 0.23
Average Daily Pain Day 4 PS (n=126, 114, 125)	2.7 Units on a scale Standard Error 0.19	2.9 Units on a scale Standard Error 0.21	2.8 Units on a scale Standard Error 0.20
Average Daily Pain Day 5 PS (n=133, 117, 133)	2.5 Units on a scale Standard Error 0.18	2.6 Units on a scale Standard Error 0.20	2.6 Units on a scale Standard Error 0.19
Average Daily Pain Day 6 PS (n=133, 125, 138)	2.3 Units on a scale Standard Error 0.18	2.5 Units on a scale Standard Error 0.19	2.4 Units on a scale Standard Error 0.18
Average Daily Pain Day 7 PS (n=132, 130, 135)	2.1 Units on a scale Standard Error 0.17	2.3 Units on a scale Standard Error 0.17	2.2 Units on a scale Standard Error 0.17
Average Daily Pain 2nd Week PS (Average) (n=134, 131, 139)	1.7 Units on a scale Standard Error 0.14	2.0 Units on a scale Standard Error 0.14	1.7 Units on a scale Standard Error 0.14
Average Daily Pain 3rd Week PS (Average) (n=114, 110, 114)	1.3 Units on a scale Standard Error 0.15	1.7 Units on a scale Standard Error 0.15	1.3 Units on a scale Standard Error 0.16
Average Daily Pain 4th Week PS (Average) (n=87, 87, 82)	1.2 Units on a scale Standard Error 0.18	1.6 Units on a scale Standard Error 0.19	1.2 Units on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=141 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=143 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=143 Participants Matching placebo capsule
Worst Daily Pain Discharge (n=140, 143, 138)	4.3 Units on a scale Standard Deviation 0.22	4.4 Units on a scale Standard Deviation 0.22	4.2 Units on a scale Standard Deviation 0.22
Worst Daily Pain Day 7 (n=123, 121, 125)	3.2 Units on a scale Standard Deviation 0.24	3.4 Units on a scale Standard Deviation 0.24	3.5 Units on a scale Standard Deviation 0.23
Worst Daily Pain Day 14 (n=129, 125, 130)	1.8 Units on a scale Standard Deviation 0.19	2.4 Units on a scale Standard Deviation 0.19	2.5 Units on a scale Standard Deviation 0.19
Worst Daily Pain Day 28 (n=141, 142, 143)	1.2 Units on a scale Standard Deviation 0.15	1.7 Units on a scale Standard Deviation 0.15	1.4 Units on a scale Standard Deviation 0.15

SECONDARY outcome

Timeframe: Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=134 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=131 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=139 Participants Matching placebo capsule
Sleep Interference Day 2 PS (n=21, 18, 20)	2.4 Units on a scale Standard Error 0.65	3.6 Units on a scale Standard Error 0.67	3.2 Units on a scale Standard Error 0.77
Sleep Interference Day 3 PS (n=88, 89, 87)	2.6 Units on a scale Standard Error 0.32	2.3 Units on a scale Standard Error 0.33	2.6 Units on a scale Standard Error 0.33
Sleep Interference Day 4 PS (n=122, 111, 119)	2.3 Units on a scale Standard Error 0.24	2.5 Units on a scale Standard Error 0.27	2.5 Units on a scale Standard Error 0.26
Sleep Interference Day 5 PS (n=133, 117, 132)	2.1 Units on a scale Standard Error 0.22	2.2 Units on a scale Standard Error 0.24	2.5 Units on a scale Standard Error 0.22
Sleep Interference Day 6 PS (n=133, 127, 138)	1.7 Units on a scale Standard Error 0.22	1.9 Units on a scale Standard Error 0.23	2.1 Units on a scale Standard Error 0.22
Sleep Interference Day 7 PS (n=132, 131, 138)	1.7 Units on a scale Standard Error 0.22	2.0 Units on a scale Standard Error 0.22	2.1 Units on a scale Standard Error 0.22
Sleep Interference 2nd Week PS (Average) (n=134, 131, 139)	1.3 Units on a scale Standard Error 0.16	1.7 Units on a scale Standard Error 0.17	1.5 Units on a scale Standard Error 0.16
Sleep Interference 3rd Week PS (Average) (n=115, 112, 113)	1.0 Units on a scale Standard Error 0.16	1.3 Units on a scale Standard Error 0.16	1.0 Units on a scale Standard Error 0.17
Sleep Interference 4th Week PS (Average) (n=87, 87, 81)	1.0 Units on a scale Standard Error 0.21	1.4 Units on a scale Standard Error 0.21	0.9 Units on a scale Standard Error 0.22

SECONDARY outcome

Timeframe: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=149 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=147 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=154 Participants Matching placebo capsule
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores Baseline (n=149, 147, 154)	0 Units on a scale Standard Error 0	0 Units on a scale Standard Error 0	0 Units on a scale Standard Error 0
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores Discharge (n=133, 131, 130)	2.57 Units on a scale Standard Error 0.194	2.62 Units on a scale Standard Error 0.198	2.90 Units on a scale Standard Error 0.200
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores Day 7 (n=121, 119, 123)	1.96 Units on a scale Standard Error 0.201	2.09 Units on a scale Standard Error 0.206	2.52 Units on a scale Standard Error 0.198
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores Day 28 (n=140, 141, 142)	0.85 Units on a scale Standard Error 0.122	1.01 Units on a scale Standard Error 0.122	1.07 Units on a scale Standard Error 0.123
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores Day 14 (n=129, 123, 126)	1.20 Units on a scale Standard Error 0.148	1.41 Units on a scale Standard Error 0.152	1.68 Units on a scale Standard Error 0.152

SECONDARY outcome

Timeframe: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=149 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=147 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=155 Participants Matching placebo capsule
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores Baseline (n=149, 147, 155)	0 Units on a scale Standard Error 0	0 Units on a scale Standard Error 0	0 Units on a scale Standard Error 0
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores Discharge (n=140, 141, 138)	2.62 Units on a scale Standard Error 0.137	2.60 Units on a scale Standard Error 0.137	2.53 Units on a scale Standard Error 0.141
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores Day 7 (n=122, 121, 125)	2.05 Units on a scale Standard Error 0.172	2.16 Units on a scale Standard Error 0.177	2.20 Units on a scale Standard Error 0.169
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores Day 14 (n=129, 124, 130)	1.19 Units on a scale Standard Error 0.137	1.63 Units on a scale Standard Error 0.142	1.61 Units on a scale Standard Error 0.138
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores Day 28 (n=141, 142, 143)	0.79 Units on a scale Standard Error 0.110	0.98 Units on a scale Standard Error 0.110	0.83 Units on a scale Standard Error 0.110

SECONDARY outcome

Timeframe: Day 1

Population: mITT; N=number of evaluable participants analyzed

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=28 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=32 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=40 Participants Matching placebo capsule
Participant Satisfaction With Study Medication - Surgery Day Excellent	14.3 Percentage of participants	3.1 Percentage of participants	20.0 Percentage of participants
Participant Satisfaction With Study Medication - Surgery Day Good	42.9 Percentage of participants	62.5 Percentage of participants	35.0 Percentage of participants
Participant Satisfaction With Study Medication - Surgery Day Fair	39.3 Percentage of participants	31.3 Percentage of participants	30.0 Percentage of participants
Participant Satisfaction With Study Medication - Surgery Day Poor	3.6 Percentage of participants	3.1 Percentage of participants	15.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 PS

Population: mITT; N=number of evaluable participants analyzed

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=150 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=148 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=154 Participants Matching placebo capsule
Participant Satisfaction With Study Medication - Day 1 PS Excellent	13.3 Percentage of participants	17.6 Percentage of participants	16.2 Percentage of participants
Participant Satisfaction With Study Medication - Day 1 PS Good	56.0 Percentage of participants	47.3 Percentage of participants	45.5 Percentage of participants
Participant Satisfaction With Study Medication - Day 1 PS Fair	26.7 Percentage of participants	29.1 Percentage of participants	30.5 Percentage of participants
Participant Satisfaction With Study Medication - Day 1 PS Poor	4.0 Percentage of participants	6.1 Percentage of participants	7.8 Percentage of participants

SECONDARY outcome

Timeframe: Day 2 PS

Population: mITT; N=number of evaluable participants analyzed;

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=114 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=119 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=117 Participants Matching placebo capsule
Participant Satisfaction With Study Medication - Day 2 PS Good	49.1 Percentage of participants	54.6 Percentage of participants	47.0 Percentage of participants
Participant Satisfaction With Study Medication - Day 2 PS Fair	25.4 Percentage of participants	21.8 Percentage of participants	29.1 Percentage of participants
Participant Satisfaction With Study Medication - Day 2 PS Excellent	21.9 Percentage of participants	17.6 Percentage of participants	16.2 Percentage of participants
Participant Satisfaction With Study Medication - Day 2 PS Poor	3.5 Percentage of participants	5.9 Percentage of participants	7.7 Percentage of participants

SECONDARY outcome

Timeframe: Day 3 PS

Population: mITT; N=number of evaluable participants analyzed

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=44 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=40 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=34 Participants Matching placebo capsule
Participant Satisfaction With Study Medication - Day 3 PS Good	52.3 Percentage of participants	47.5 Percentage of participants	50.0 Percentage of participants
Participant Satisfaction With Study Medication - Day 3 PS Excellent	15.9 Percentage of participants	17.5 Percentage of participants	17.6 Percentage of participants
Participant Satisfaction With Study Medication - Day 3 PS Fair	31.8 Percentage of participants	30.0 Percentage of participants	29.4 Percentage of participants
Participant Satisfaction With Study Medication - Day 3 PS Poor	0 Percentage of participants	5.0 Percentage of participants	2.9 Percentage of participants

SECONDARY outcome

Timeframe: Day 4 PS

Population: mITT; N=number of evaluable participants analyzed

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=17 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=19 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=14 Participants Matching placebo capsule
Participant Satisfaction With Study Medication - Day 4 PS Poor	0 Percentage of participants	5.3 Percentage of participants	14.3 Percentage of participants
Participant Satisfaction With Study Medication - Day 4 PS Good	52.9 Percentage of participants	57.9 Percentage of participants	42.9 Percentage of participants
Participant Satisfaction With Study Medication - Day 4 PS Excellent	17.6 Percentage of participants	5.3 Percentage of participants	14.3 Percentage of participants
Participant Satisfaction With Study Medication - Day 4 PS Fair	29.4 Percentage of participants	31.6 Percentage of participants	28.6 Percentage of participants

SECONDARY outcome

Timeframe: Day 5 PS

Population: mITT; N=number of evaluable participants analyzed

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=7 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=13 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=7 Participants Matching placebo capsule
Participant Satisfaction With Study Medication - Day 5 PS Excellent	0 Percentage of participants	7.7 Percentage of participants	14.3 Percentage of participants
Participant Satisfaction With Study Medication - Day 5 PS Good	71.4 Percentage of participants	53.8 Percentage of participants	42.9 Percentage of participants
Participant Satisfaction With Study Medication - Day 5 PS Fair	28.6 Percentage of participants	38.5 Percentage of participants	28.6 Percentage of participants
Participant Satisfaction With Study Medication - Day 5 PS Poor	0 Percentage of participants	0 Percentage of participants	14.3 Percentage of participants

SECONDARY outcome

Timeframe: Discharge (day 3 up to day 7 PS)

Population: mITT; N=number of evaluable participants analyzed

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=142 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=145 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=148 Participants Matching placebo capsule
Participant Satisfaction With Study Medication - Discharge Excellent	29.6 Percentage of participants	26.2 Percentage of participants	26.4 Percentage of participants
Participant Satisfaction With Study Medication - Discharge Good	48.6 Percentage of participants	51.0 Percentage of participants	39.9 Percentage of participants
Participant Satisfaction With Study Medication - Discharge Fair	16.9 Percentage of participants	17.9 Percentage of participants	25.0 Percentage of participants
Participant Satisfaction With Study Medication - Discharge Poor	4.9 Percentage of participants	4.8 Percentage of participants	8.8 Percentage of participants

SECONDARY outcome

Timeframe: Day 7 PS

Population: mITT; N=number of evaluable participants analyzed

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=123 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=122 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=127 Participants Matching placebo capsule
Participant Satisfaction With Study Medication - Day 7 PS Excellent	36.6 Percentage of participants	36.9 Percentage of participants	25.2 Percentage of participants
Participant Satisfaction With Study Medication - Day 7 PS Good	38.2 Percentage of participants	37.7 Percentage of participants	39.4 Percentage of participants
Participant Satisfaction With Study Medication - Day 7 PS Fair	15.4 Percentage of participants	17.2 Percentage of participants	26.0 Percentage of participants
Participant Satisfaction With Study Medication - Day 7 PS Poor	9.8 Percentage of participants	8.2 Percentage of participants	9.4 Percentage of participants

SECONDARY outcome

Timeframe: Day 14 PS

Population: mITT; N=number of evaluable participants analyzed

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=130 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=126 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=131 Participants Matching placebo capsule
Participant Satisfaction With Study Medication - Day 14 PS Excellent	40.0 Percentage of participants	42.9 Percentage of participants	31.3 Percentage of participants
Participant Satisfaction With Study Medication - Day 14 PS Good	42.3 Percentage of participants	37.3 Percentage of participants	33.6 Percentage of participants
Participant Satisfaction With Study Medication - Day 14 PS Fair	11.5 Percentage of participants	16.7 Percentage of participants	24.4 Percentage of participants
Participant Satisfaction With Study Medication - Day 14 PS Poor	6.2 Percentage of participants	3.2 Percentage of participants	10.7 Percentage of participants

SECONDARY outcome

Timeframe: Day 28 PS

Population: mITT; N=number of evaluable participants analyzed

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=139 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=142 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=143 Participants Matching placebo capsule
Participant Satisfaction With Study Medication - Day 28 PS Good	41.7 Percentage of participants	34.5 Percentage of participants	35.0 Percentage of participants
Participant Satisfaction With Study Medication - Day 28 PS Poor	6.5 Percentage of participants	9.2 Percentage of participants	7.0 Percentage of participants
Participant Satisfaction With Study Medication - Day 28 PS Excellent	42.4 Percentage of participants	40.1 Percentage of participants	34.3 Percentage of participants
Participant Satisfaction With Study Medication - Day 28 PS Fair	9.4 Percentage of participants	16.2 Percentage of participants	23.8 Percentage of participants

SECONDARY outcome

Timeframe: Discharge (day 3 up to day 7 PS), Day 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=138 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=137 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=139 Participants Matching placebo capsule
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication Efficacy Subscale/Discharge (n=138, 137, 139)	76.68 Units on a scale Standard Error 2.264	75.04 Units on a scale Standard Error 2.304	73.77 Units on a scale Standard Error 2.342
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication Medication Subscale/Discharge (n=138, 137, 139)	79.43 Units on a scale Standard Error 1.717	78.45 Units on a scale Standard Error 1.747	76.71 Units on a scale Standard Error 1.776
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication Medication Subscale/Day 28 (n=133, 134, 137)	82.52 Units on a scale Standard Error 1.619	80.16 Units on a scale Standard Error 1.601	78.26 Units on a scale Standard Error 1.615
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication Characteristic Subscale/Discharge (n=138,136,138)	82.15 Units on a scale Standard Error 1.565	81.88 Units on a scale Standard Error 1.597	79.58 Units on a scale Standard Error 1.623
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication Characteristic Subscale/Day 28 (n=133, 133, 137)	84.82 Units on a scale Standard Error 1.448	83.16 Units on a scale Standard Error 1.438	81.69 Units on a scale Standard Error 1.445
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication Efficacy Subscale/Day 28 (n=133, 134, 136)	80.20 Units on a scale Standard Error 2.161	76.92 Units on a scale Standard Error 2.138	74.82 Units on a scale Standard Error 2.166

SECONDARY outcome

Timeframe: Discharge (day 3 up to day 7 PS), Day 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=139 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=141 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=141 Participants Matching placebo capsule
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication Discharge (n=139, 141, 140)	72.73 Units on a scale Standard Error 2.080	66.28 Units on a scale Standard Error 2.099	72.82 Units on a scale Standard Error 2.159
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication Day 28 (n=133, 135, 141)	76.41 Units on a scale Standard Error 2.180	69.53 Units on a scale Standard Error 2.181	69.05 Units on a scale Standard Error 2.156

SECONDARY outcome

Timeframe: Discharge (day 3 up to day 7 PS) and day 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, "confined to bed"). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=140 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=143 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=142 Participants Matching placebo capsule
Quality of Life Using EuroQol (EQ-5D) Health State Profile EQ-5D 2001, Day 28 (n=140, 143, 142)	0.81 Units on a scale Standard Error 0.014	0.78 Units on a scale Standard Error 0.014	0.78 Units on a scale Standard Error 0.014
Quality of Life Using EuroQol (EQ-5D) Health State Profile EQ-5D 1997, Discharge (n=138, 141, 138)	0.57 Units on a scale Standard Error 0.021	0.61 Units on a scale Standard Error 0.021	0.58 Units on a scale Standard Error 0.022
Quality of Life Using EuroQol (EQ-5D) Health State Profile EQ-5D 1997, Day 28 (n=140, 143, 142)	0.81 Units on a scale Standard Error 0.014	0.78 Units on a scale Standard Error 0.014	0.78 Units on a scale Standard Error 0.014
Quality of Life Using EuroQol (EQ-5D) Health State Profile EQ-5D 2001, Discharge (n=138, 141, 138)	0.59 Units on a scale Standard Error 0.018	0.62 Units on a scale Standard Error 0.018	0.60 Units on a scale Standard Error 0.019

SECONDARY outcome

Timeframe: Day 1 up to Day 7 PS

Population: mITT

Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=151 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=149 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=156 Participants Matching placebo capsule
Time to Meet Hospital Discharge Criteria	57.670 Hours Standard Error 2.829	60.751 Hours Standard Error 2.678	58.745 Hours Standard Error 2.786

SECONDARY outcome

Timeframe: Day 1 up to Day 7 PS

Population: mITT

Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=151 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=149 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=156 Participants Matching placebo capsule
Time to Actual Discharge	79.339 Hours Standard Error 2.547	85.221 Hours Standard Error 3.935	78.740 Hours Standard Error 2.441

SECONDARY outcome

Timeframe: 3 and 6 Months PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed. Participants reported as no chronic pain in the 3 month visit were carried over to the missing data at 6 month visit.

Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=138 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=127 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=141 Participants Matching placebo capsule
Incidence of Chronic Post-operative Pain Months 3 PS (n =136, 127, 138)	12.5 Percentage of participants	17.3 Percentage of participants	10.1 Percentage of participants
Incidence of Chronic Post-operative Pain Months 6 PS (n =138, 127, 141)	6.5 Percentage of participants	6.3 Percentage of participants	4.3 Percentage of participants

SECONDARY outcome

Timeframe: Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=148 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=147 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=154 Participants Matching placebo capsule
Total Clinically Meaningful Event (CME) Score Surgery Day (n=26, 25, 32)	0.9 Units on a scale Standard Error 0.29	0.8 Units on a scale Standard Error 0.30	0.9 Units on a scale Standard Error 0.26
Total Clinically Meaningful Event (CME) Score Day 1 PS (n=148, 147, 154)	1.1 Units on a scale Standard Error 0.13	1.1 Units on a scale Standard Error 0.13	1.2 Units on a scale Standard Error 0.13
Total Clinically Meaningful Event (CME) Score Day 2 PS (n=108, 116, 114)	0.6 Units on a scale Standard Error 0.12	0.6 Units on a scale Standard Error 0.12	0.7 Units on a scale Standard Error 0.12
Total Clinically Meaningful Event (CME) Score Day 3 PS (n=38, 36, 32)	0.5 Units on a scale Standard Error 0.19	0.7 Units on a scale Standard Error 0.17	0.3 Units on a scale Standard Error 0.19
Total Clinically Meaningful Event (CME) Score Day 4 PS (n=14, 16, 11)	0.0 Units on a scale Standard Error 0.19	0.4 Units on a scale Standard Error 0.15	0.3 Units on a scale Standard Error 0.22
Total Clinically Meaningful Event (CME) Score Day 5 PS (n=5, 9, 6)	0.4 Units on a scale Standard Error 0.19	0.1 Units on a scale Standard Error 0.13	0.3 Units on a scale Standard Error 0.18
Total Clinically Meaningful Event (CME) Score Discharge (n=133, 132, 133)	0.4 Units on a scale Standard Error 0.09	0.4 Units on a scale Standard Error 0.09	0.3 Units on a scale Standard Error 0.09
Total Clinically Meaningful Event (CME) Score Day 7 PS (n=119, 117, 120)	0.2 Units on a scale Standard Error 0.06	0.4 Units on a scale Standard Error 0.06	0.2 Units on a scale Standard Error 0.06
Total Clinically Meaningful Event (CME) Score Day 14 PS (n=119, 116, 124)	0.1 Units on a scale Standard Error 0.06	0.2 Units on a scale Standard Error 0.06	0.1 Units on a scale Standard Error 0.06
Total Clinically Meaningful Event (CME) Score Day 28 PS (n=129, 135, 136)	0.0 Units on a scale Standard Error 0.06	0.2 Units on a scale Standard Error 0.06	0.2 Units on a scale Standard Error 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge (day 3 up to day 7 PS)

Population: Safety population all participants who were administered at least one dose of double blind medication, and for whom at least one post-baseline safety evaluation was obtained were included.

Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=161 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=166 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=167 Participants Matching placebo capsule
Percentage of Participants With Wound Healing Complications - Discharge Superficial Incision SSI	3.1 Percentage of participants	1.2 Percentage of participants	0.6 Percentage of participants
Percentage of Participants With Wound Healing Complications - Discharge Deep Incision SSI	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Wound Healing Complications - Discharge Organ/space SSI	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Wound Healing Complications - Discharge Non-infectious Wound Healing	0 Percentage of participants	1.2 Percentage of participants	0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 7 PS

Population: Safety population

Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=161 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=166 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=167 Participants Matching placebo capsule
Percentage of Participants With Wound Healing Complications - Day 7 PS Superficial Incision SSI	1.9 Percentage of participants	2.5 Percentage of participants	0.6 Percentage of participants
Percentage of Participants With Wound Healing Complications - Day 7 PS Deep Incision SSI	0.6 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Wound Healing Complications - Day 7 PS Organ/space SSI	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Wound Healing Complications - Day 7 PS Non-infectious Wound Healing	3.8 Percentage of participants	1.9 Percentage of participants	0.6 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14 PS

Population: Safety population

Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=161 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=166 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=167 Participants Matching placebo capsule
Percentage of Participants With Wound Healing Complications - Day 14 PS Superficial Incision SSI	5.0 Percentage of participants	2.5 Percentage of participants	2.4 Percentage of participants
Percentage of Participants With Wound Healing Complications - Day 14 PS Deep Incision SSI	0.6 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Wound Healing Complications - Day 14 PS Organ/space SSI	0.6 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Wound Healing Complications - Day 14 PS Non-infectious Wound Healing	4.4 Percentage of participants	2.5 Percentage of participants	0.6 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28 PS

Population: Safety population

Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=161 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=166 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=167 Participants Matching placebo capsule
Percentage of Participants With Wound Healing Complications - Day 28 PS Superficial Incision SSI	1.9 Percentage of participants	1.9 Percentage of participants	1.2 Percentage of participants
Percentage of Participants With Wound Healing Complications - Day 28 PS Deep Incision SSI	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Wound Healing Complications - Day 28 PS Organ/space SSI	0 Percentage of participants	0 Percentage of participants	0.6 Percentage of participants
Percentage of Participants With Wound Healing Complications - Day 28 PS Non-infectious Wound Healing	2.5 Percentage of participants	2.5 Percentage of participants	0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 28 PS

Population: Safety population

Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=161 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=166 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=167 Participants Matching placebo capsule
Percentage of Participants With Wound Healing Complications - End of Treatment Superficial Incision SSI	0 Percentage of participants	1.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With Wound Healing Complications - End of Treatment Organ/space SSI	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Wound Healing Complications - End of Treatment Non-infectious Wound Healing	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Wound Healing Complications - End of Treatment Deep Incision SSI	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1

Population: mITT

Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=151 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=149 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=156 Participants Matching placebo capsule
Incision Length Correlated With Worst Pain	7.1074 Centimeter (cm) Standard Error 0.2010	7.2324 Centimeter (cm) Standard Error 0.1966	7.4437 Centimeter (cm) Standard Error 0.1977

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge (day 3 up to day 7 PS)

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Outcome measures

Outcome measures
Measure	Pregabalin 150mg n=139 Participants Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=145 Participants Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=143 Participants Matching placebo capsule
Neuropathic Pain Symptom Inventory (NPSI) Total subscale(n=132, 131, 136)	0.073 Units on a scale Standard Error 0.0057	0.070 Units on a scale Standard Error 0.0057	0.076 Units on a scale Standard Error 0.0058
Neuropathic Pain Symptom Inventory (NPSI) Burning Spontaneous subscale (n=139, 145, 143)	1.86 Units on a scale Standard Error 0.235	1.80 Units on a scale Standard Error 0.231	1.75 Units on a scale Standard Error 0.235
Neuropathic Pain Symptom Inventory (NPSI) Pressing Spontaneous subscale (n=139, 145, 143)	1.74 Units on a scale Standard Error 0.166	1.60 Units on a scale Standard Error 0.164	1.57 Units on a scale Standard Error 0.168
Neuropathic Pain Symptom Inventory (NPSI) Paroxysmal pain subscale (n=138, 140, 143)	1.08 Units on a scale Standard Error 0.155	0.95 Units on a scale Standard Error 0.154	1.18 Units on a scale Standard Error 0.156
Neuropathic Pain Symptom Inventory (NPSI) Evoked Pain subscale (n=134, 135, 142)	2.14 Units on a scale Standard Error 0.177	2.27 Units on a scale Standard Error 0.177	2.27 Units on a scale Standard Error 0.175
Neuropathic Pain Symptom Inventory (NPSI) Paresthesia/dysesthesia (n=136, 140, 141)	0.46 Units on a scale Standard Error 0.129	0.67 Units on a scale Standard Error 0.127	0.91 Units on a scale Standard Error 0.128

Adverse Events

Pregabalin 150mg

Serious events: 9 serious events

Other events: 125 other events

Deaths: 0 deaths

Pregabalin 300 mg

Serious events: 11 serious events

Other events: 128 other events

Deaths: 0 deaths

Placebo

Serious events: 15 serious events

Other events: 124 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pregabalin 150mg n=161 participants at risk Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=166 participants at risk Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=167 participants at risk Matching placebo capsule
Blood and lymphatic system disorders Anaemia	0.00% 0/161	0.60% 1/166	0.00% 0/167
Cardiac disorders Atrioventricular block complete	0.00% 0/161	0.00% 0/166	0.60% 1/167
Cardiac disorders Tachycardia	0.00% 0/161	0.60% 1/166	0.00% 0/167
Gastrointestinal disorders Abdominal distension	0.00% 0/161	0.00% 0/166	0.60% 1/167
Gastrointestinal disorders Abdominal pain	0.62% 1/161	0.00% 0/166	0.60% 1/167
Gastrointestinal disorders Abdominal pain lower	0.00% 0/161	0.60% 1/166	0.00% 0/167
Gastrointestinal disorders Constipation	0.00% 0/161	0.00% 0/166	0.60% 1/167
Gastrointestinal disorders Gastritis	0.62% 1/161	0.00% 0/166	0.00% 0/167
Gastrointestinal disorders Ileus	0.62% 1/161	0.00% 0/166	0.00% 0/167
Gastrointestinal disorders Intestinal obstruction	0.00% 0/161	0.00% 0/166	0.60% 1/167
Gastrointestinal disorders Rectal perforation	0.00% 0/161	0.00% 0/166	0.60% 1/167
Gastrointestinal disorders Umbilical hernia	0.62% 1/161	0.00% 0/166	0.00% 0/167
General disorders Chest pain	0.00% 0/161	0.00% 0/166	0.60% 1/167
General disorders Impaired healing	0.00% 0/161	0.60% 1/166	0.00% 0/167
General disorders Pyrexia	0.62% 1/161	0.60% 1/166	0.60% 1/167
Infections and infestations Incision site infection	0.00% 0/161	0.00% 0/166	0.60% 1/167
Infections and infestations Pneumonia	0.00% 0/161	0.00% 0/166	0.60% 1/167
Infections and infestations Postoperative wound infection	1.2% 2/161	0.60% 1/166	0.60% 1/167
Infections and infestations Pyelonephritis	0.00% 0/161	0.00% 0/166	0.60% 1/167
Infections and infestations Sepsis	0.00% 0/161	0.60% 1/166	0.00% 0/167
Infections and infestations Urinary tract infection	0.00% 0/161	0.60% 1/166	0.60% 1/167
Infections and infestations Wound infection	0.00% 0/161	0.60% 1/166	0.60% 1/167
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/161	0.00% 0/166	0.60% 1/167
Injury, poisoning and procedural complications Post procedural haematoma	0.62% 1/161	0.60% 1/166	0.00% 0/167
Injury, poisoning and procedural complications Postoperative ileus	0.62% 1/161	0.00% 0/166	0.00% 0/167
Injury, poisoning and procedural complications Ureteric injury	0.00% 0/161	0.00% 0/166	0.60% 1/167
Injury, poisoning and procedural complications Wound complication	0.00% 0/161	0.00% 0/166	0.60% 1/167
Investigations Liver function test abnormal	0.62% 1/161	0.00% 0/166	0.00% 0/167
Investigations Oxygen saturation decreased	0.62% 1/161	0.00% 0/166	0.00% 0/167
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/161	0.60% 1/166	0.00% 0/167
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/161	0.60% 1/166	0.00% 0/167
Renal and urinary disorders Dysuria	0.00% 0/161	0.00% 0/166	0.60% 1/167
Renal and urinary disorders Ureteric stenosis	0.00% 0/161	0.60% 1/166	0.00% 0/167
Reproductive system and breast disorders Pelvic haematoma	0.00% 0/161	0.00% 0/166	0.60% 1/167
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/161	0.60% 1/166	0.00% 0/167
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/161	0.00% 0/166	0.60% 1/167
Vascular disorders Haematoma	0.00% 0/161	0.60% 1/166	0.00% 0/167
Vascular disorders Hypertension	0.00% 0/161	0.60% 1/166	0.00% 0/167

Other adverse events

Other adverse events
Measure	Pregabalin 150mg n=161 participants at risk Pregabalin 75 mg twice a day (150 mg/day total)	Pregabalin 300 mg n=166 participants at risk Pregabalin 150 mg twice a day (300 mg/day total)	Placebo n=167 participants at risk Matching placebo capsule
Blood and lymphatic system disorders Anaemia	5.6% 9/161	3.0% 5/166	3.0% 5/167
Cardiac disorders Tachycardia	2.5% 4/161	3.6% 6/166	1.8% 3/167
Eye disorders Vision blurred	1.2% 2/161	2.4% 4/166	0.00% 0/167
Gastrointestinal disorders Abdominal distension	3.7% 6/161	3.0% 5/166	1.8% 3/167
Gastrointestinal disorders Abdominal pain	3.7% 6/161	2.4% 4/166	6.0% 10/167
Gastrointestinal disorders Constipation	28.6% 46/161	29.5% 49/166	26.9% 45/167
Gastrointestinal disorders Diarrhoea	2.5% 4/161	1.2% 2/166	4.2% 7/167
Gastrointestinal disorders Dyspepsia	3.1% 5/161	3.6% 6/166	3.6% 6/167
Gastrointestinal disorders Flatulence	9.9% 16/161	6.0% 10/166	7.8% 13/167
Gastrointestinal disorders Nausea	41.6% 67/161	36.1% 60/166	45.5% 76/167
Gastrointestinal disorders Retching	0.00% 0/161	3.6% 6/166	2.4% 4/167
Gastrointestinal disorders Vomiting	20.5% 33/161	12.0% 20/166	18.0% 30/167
General disorders Chills	0.62% 1/161	1.2% 2/166	2.4% 4/167
General disorders Fatigue	23.6% 38/161	27.7% 46/166	20.4% 34/167
General disorders Oedema peripheral	2.5% 4/161	0.60% 1/166	0.60% 1/167
General disorders Pain	2.5% 4/161	1.8% 3/166	1.8% 3/167
General disorders Pyrexia	19.3% 31/161	17.5% 29/166	14.4% 24/167
Infections and infestations Urinary tract infection	8.1% 13/161	7.2% 12/166	4.8% 8/167
Infections and infestations Wound infection	3.1% 5/161	3.0% 5/166	1.8% 3/167
Injury, poisoning and procedural complications Procedural pain	1.2% 2/161	2.4% 4/166	1.2% 2/167
Musculoskeletal and connective tissue disorders Back pain	3.7% 6/161	2.4% 4/166	2.4% 4/167
Nervous system disorders Disturbance in attention	14.9% 24/161	18.1% 30/166	13.8% 23/167
Nervous system disorders Dizziness	31.7% 51/161	31.3% 52/166	22.2% 37/167
Nervous system disorders Headache	16.8% 27/161	13.9% 23/166	11.4% 19/167
Nervous system disorders Hypoaesthesia	0.00% 0/161	2.4% 4/166	2.4% 4/167
Nervous system disorders Migraine	1.2% 2/161	2.4% 4/166	1.2% 2/167
Nervous system disorders Paraesthesia	2.5% 4/161	0.00% 0/166	1.2% 2/167
Nervous system disorders Somnolence	24.2% 39/161	23.5% 39/166	21.6% 36/167
Psychiatric disorders Confusional state	7.5% 12/161	7.2% 12/166	5.4% 9/167
Psychiatric disorders Insomnia	5.6% 9/161	5.4% 9/166	6.0% 10/167
Renal and urinary disorders Dysuria	8.7% 14/161	13.3% 22/166	9.6% 16/167
Respiratory, thoracic and mediastinal disorders Cough	2.5% 4/161	1.8% 3/166	1.2% 2/167
Skin and subcutaneous tissue disorders Pruritus	16.8% 27/161	13.3% 22/166	15.6% 26/167
Skin and subcutaneous tissue disorders Rash	0.00% 0/161	2.4% 4/166	0.00% 0/167
Vascular disorders Haematoma	3.7% 6/161	3.6% 6/166	1.2% 2/167
Vascular disorders Hypertension	1.9% 3/161	2.4% 4/166	1.2% 2/167

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER