NCT00663962

A Prospective, Randomized, Double Blinded, Placebo Controlled Pilot Study Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome

Completed Phase 4 Results posted Last updated 29 January 2016

What this trial tests

Phase 4 trial testing Pregabalin in Chronic Pain in 15 participants. Completed in 1 May 2009.

Timeline

1 April 2008

Primary endpoint
1 November 2008

1 May 2009

Quick facts

Lead sponsor	Queen's University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	15
Start date	1 April 2008
Primary completion	1 November 2008
Estimated completion	1 May 2009
Sites	1 location across Canada

Drugs / interventions tested

• Pregabalin (Pregabalin) — full drug profile →
• Placebo

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

Queen's University

Who can join

Adults 18 to 75, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  Time frame: 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)

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacotherapy for the prevention of chronic pain after surgery in adults.
   Chaparro LE, Smith SA, Moore RA, Wiffen PJ, et al · · 2013 · cited 119× · PMID 23881791 · DOI 10.1002/14651858.cd008307.pub2