At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Double Blinded, Placebo Controlled Pilot Study Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome
In Brief
A Phase 4 clinical trial evaluating Pregabalin and Placebo for Chronic Pain. Completed, enrolled 15 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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)