Pregabalin and Post-thoracotomy Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Pregabalin; Placebo
Intervention description: 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)
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Thoracotomy; Post-surgical; Pregabalin

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.
    

Eligibility criteria:

        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.