A Phase 4 interventional study of Pregabalin and Placebo in Chronic Pain, sponsored by Queen's University. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-02-29.
Sponsored by Queen's University · Phase 4, Interventional, and Treatment
With Institutional Ethics Board approval and signed informed consent, a pilot investigation was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoperatively and 7 days postoperatively (BID) or 3) placebo for same regimen to assess the feasibility, safety and compliance of this drug regimen on this patient population. This assessment was necessary in order to plan a future fully powered randomized controlled trial looking at the efficacy of perioperative pregabalin ifor reducing the incidence/severity of chronic post-thoracotomy pain.
Chronic post thoracotomy pain syndrome (CPTPS) is a significant problem that has important effects on patients' daily activities. The severity of postoperative pain and the central sensitization associated with it are thought to play a role in the chronification of acute pain. Gabapentin has been shown to be effective in reducing acute post-surgical pain and treating CPTPS. There is conflicting data regarding its effects on the development of chronic post-surgical pain. Although pregabalin is similar to gabapentin there are only a few studies examining its use in the modification of post-surgical pain but evidence suggests that it might be effective. There are no studies examining the effect of pregabalin on the development of chronic post-surgical pain. Our hypothesis is that perioperative use of pregabalin will decrease the incidence of CPTPS. Our ultimate goal is to conduct a multi-center study assessing the effect of perioperative oral pregabalin on the development of CPTPS. Prior to this, we will carry out a prospective, randomized, placebo controlled, double-blinded pilot study to assess the feasibility, safety, and compliance associated with perioperative use of oral pregabalin in patients undergoing video assisted thoracotomy surgery (VATS) or open thoracotomy procedures.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Exclusion Criteria:
Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=3) or Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=4).
Drug: Pregabalin
An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
Drug: Placebo
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.
An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op (N=8)
The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.
Time frame: 2, 4, and 6 months
Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively
Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score \> 4 on a 10 point NRS scale)
Time frame: 2 months postoperatively
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.
| Milestone | Pregabalin | Placebo |
|---|---|---|
| Started | 7 | 8 |
| Completed | 6 | 8 |
| Not completed | 1 | 0 |
| Withdrew: Somnolence | 1 | 0 |
Results for this outcome have not been posted.
Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score \> 4 on a 10 point NRS scale)
| participants | Pregabalin | Placebo |
|---|---|---|
| Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively | 0 | 0 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin | — | 0/7 (0%) | 1/7 (14.3%) |
| Placebo | — | 0/8 (0%) | 0/8 (0%) |
| Event | Pregabalin | Placebo |
|---|---|---|
| somnolenceGeneral disorders | 1/7 | 0/8 |
Of the 7 participants randomized to the pregabalin group, 3 receieved 150mg of pregabalin while 4 recieved 300mg pregabalin.
| Age, Categorical(Participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 4 | 7 |
| >=65 years | 4 | 4 | 8 |
| Age, Continuous(years) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Mean | 60.6 ± 17.6 | 55.0 ± 18.6 | 57.6 ± 17.7 |
| Sex: Female, Male(Participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Female | 2 | 4 | 6 |
| Male | 5 | 4 | 9 |
| Region of Enrollment(participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Canada | 7 | 8 | 15 |
Plan to share: No
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