Overview

This trial is active, not recruiting.

Conditions chronic, thoracotomy, pain
Treatments pregabalin, placebo
Phase phase 4
Sponsor Queen's University
Start date April 2008
End date May 2009
Trial size 15 participants
Trial identifier NCT00663962, ANAE-139-08

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
PHASE 1 (N=7) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=8) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
pregabalin
PHASE 1 (N=7) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=8) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
(Placebo Comparator)
An identical placebo 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.

Primary Outcomes

Measure
The primary outcome measure for the final study will be the incidence of CPTPS at 2 months.
time frame: 2, 4, and 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Elective thoracotomy (ET) or video assisted thoracotomy (VAT); - Understanding and provision of written informed consent; - Age > 18 and < 75; - ASA class I, II or III. Exclusion Criteria: - Inability to adhere to study protocol; - Intolerance or known hypersensitivity to any agents to be used in the study; - Contraindication to thoracic epidural placement in open thoracotomy patients; - Inability to respond to the study questionnaire; - Renal insufficiency (serum creatinine > 1.5 x upper limit of normal); - BMI > 40; - Confounding procedural factors which might affect validity of data; - Surgery for tumour extending into the chest wall; - Requirement for second thoracotomy or re-occurrence of disease after surgery; - Potential interaction with study medications and patient's current medications; - Current ETOH or substance abuse; - Pre-existing chronic pain requiring chronic analgesic use; - History of seizure disorder requiring treatment with an anti-convulsant; - Current therapy with thiazolidinedione class oral hypoglycemic agents (e.g. Actos, Avandia, or Avandamet); - History of congestive heart failure; - Major psychiatric disorder; - Insufficient safety data in a specific patient population; - Pregnant or breastfeeding.

Additional Information

Official title A Prospective, Randomized, Double Blinded, Placebo Controlled Pilot Study Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome
Principal investigator Jorge E Zamora, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Queen's University.