Pregabalin and Post-thoracotomy Pain
CompletedPhase 4NCT00663962
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Brief summary (from the registry)
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
- 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
- Conditions
- Interventions
- Sponsor
- Queen's University
- Start date
- 2008-04
- Primary completion
- 2008-11
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00663962