Trial Outcomes & Findings for Perioperative Administration of Pregabalin for Pain After Mastectomy (NCT NCT00938548)

Results Overview

Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

1, 6, 24, 48 hour

Results posted on

2010-05-25

Participant Flow

This study was approved by the Institutional Ethics Committee of Yonsei University Medical Center. Datas were collected between June and December 2009.

Of a total of 78 patients assessed for eligibility, 70 subjects received pregabalin or placebo after randomization. Eight patients were excluded because some patients refused to participate and some patients have psychiatric disorder and insulin-dependent DM.

Participant milestones

Participant milestones
Measure	Placebo Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Perioperative Administration of Pregabalin for Pain After Mastectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=35 Participants Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=35 Participants Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=93 Participants	33 Participants n=4 Participants	67 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Age Continuous	49 years STANDARD_DEVIATION 8 • n=93 Participants	51 years STANDARD_DEVIATION 9 • n=4 Participants	50 years STANDARD_DEVIATION 8 • n=27 Participants
Sex: Female, Male Female	35 Participants n=93 Participants	35 Participants n=4 Participants	70 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Korea, Republic of	35 participants n=93 Participants	35 participants n=4 Participants	70 participants n=27 Participants

PRIMARY outcome

Timeframe: 1, 6, 24, 48 hour

Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=35 Participants Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. 1 hr	7 Units on a scale Full Range 1.8 • Interval 3.0 to 10.0	5 Units on a scale Full Range 2.1 • Interval 0.0 to 9.0
Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. 6 hr	6 Units on a scale Full Range 2.1 • Interval 2.0 to 10.0	5 Units on a scale Full Range 2.2 • Interval 2.0 to 10.0
Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. 24 hr	5 Units on a scale Full Range 1.7 • Interval 1.0 to 8.0	3 Units on a scale Full Range 1.5 • Interval 1.0 to 7.0
Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. 48 hr	3 Units on a scale Full Range 1.8 • Interval 0.0 to 7.0	2 Units on a scale Full Range 1.3 • Interval 1.0 to 5.0

PRIMARY outcome

Timeframe: 1, 6, 24, 48 hour

Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=35 Participants Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. sedation	8 participants	13 participants
Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. dizziness	12 participants	17 participants
Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. PONV	4 participants	3 participants
Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. headache	9 participants	5 participants

SECONDARY outcome

Timeframe: 1 week, 1 month

Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=35 Participants Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Pain Scores (VNRS) at 1 Week and 1 Month After Operation 1 week	2.9 Units on a scale Standard Deviation 1.3	1.4 Units on a scale Standard Deviation 0.9
Pain Scores (VNRS) at 1 Week and 1 Month After Operation 1 month	1.7 Units on a scale Standard Deviation 1.6	0.6 Units on a scale Standard Deviation 0.6

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Pregabalin

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=35 participants at risk Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=35 participants at risk Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Nervous system disorders dizziness	34.3% 12/35	48.6% 17/35
Nervous system disorders sedation	22.9% 8/35	37.1% 13/35
Nervous system disorders headache	25.7% 9/35	14.3% 5/35
Gastrointestinal disorders PONV	11.4% 4/35	8.6% 3/35

Additional Information

Dr. So Yeon Kim

Department of Anaesthesiology and Pain Medicine and Anaesthesia and Pain Research Institute, Department of surgery, Yonsei University College of Medicine

Phone: 82-2-2227-3642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place