Trial Outcomes & Findings for Pregabalin and Post-thoracotomy Pain (NCT NCT00663962)

NCT ID: NCT00663962

Last Updated: 2016-02-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: 2, 4, and 6 months
• Results posted on: 2016-02-29

Participant Flow

REB approval from our institution was received to enroll 15 patients, who had given written informed consent, into this pilot study. All elective ASA I - III patients aged 18 - 75 scheduled for open thoracotomy or video assisted thoracotomy (VAT) were screened for inclusion in this study.

Thirty-nine patients were screened between April 23 and November 27, 2008. Fifteen patients were eligible for inclusion.

Participant milestones

Measure	Pregabalin PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.	Placebo An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
Overall Study STARTED	7	8
Overall Study COMPLETED	6	8
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Pregabalin PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.	Placebo An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
Overall Study somnolence	1	0

Baseline Characteristics

Pregabalin and Post-thoracotomy Pain

Baseline characteristics by cohort

Measure	Pregabalin n=7 Participants PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.	Placebo n=8 Participants An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	60.6 years STANDARD_DEVIATION 17.6 • n=5 Participants	55.0 years STANDARD_DEVIATION 18.6 • n=7 Participants	57.6 years STANDARD_DEVIATION 17.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Canada	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 2, 4, and 6 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 months postoperatively

Population: pilot study--convenience

Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale)

Outcome measures

Measure	Pregabalin n=7 Participants Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.	Placebo n=8 Participants An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively	0 participants	0 participants

Adverse Events

Pregabalin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pregabalin n=7 participants at risk Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.	Placebo n=8 participants at risk An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
General disorders somnolence	14.3% 1/7 • Number of events 1	0.00% 0/8

Additional Information

Pregabalin and Post-thoracotomy pain

Queen's University

Phone: (613) 548-7827

Email: zamoraj@kgh.kari.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place