Status:
COMPLETED
Pregabalin and Post-thoracotomy Pain
Lead Sponsor:
Queen's University
Conditions:
Chronic Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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...
Detailed Description
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 assoc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00663962
Start Date
April 1 2008
End Date
May 1 2009
Last Update
February 29 2016
Active Locations (1)
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1
Kingston General Hospital
Kingston, Ontario, Canada, K7L2V7