Status:
WITHDRAWN
The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome
Lead Sponsor:
Queen's University
Collaborating Sponsors:
McMaster University
Conditions:
Chronic Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (CPTPS).
Detailed Description
A total of 200 patients scheduled for lateral thoracotomy will be randomly assigned to receive either placebo or 150 mg pregabalin (Lyrica)1 hour prior to surgery, 12 hr after surgery and then every 1...
Eligibility Criteria
Inclusion
- Elective open thoracotomy for primary thoracic surgery, understanding and provision of written informed consent, ASA class I II or III
Exclusion
- Inability ot adhere to study protocol:
- intolerance or hypersensitivity to any agents to be used in the study, contraindication to thoracic epidural placement
- inability to respond to the study questionnaire
- renal insufficiency(serum creatinine \> 1.5 upper limit of normal)
- Body Mass index \> 40
- planned post-operative ventilation.
- Confounding procedural factors which might affect validity of data:
- previous ipsilateral thoracotomy
- surgery for tumor extending into the chest wall
- rest pain in proposed surgical area pre-operatively
- chest tube in situ at time of surgery
- requirement for second thoracotomy or re-occurrence of disease after surgery \*isolated pleuroscopy or pleurodesis procedures.
- Potential interaction with study medications and patient's current medications:
- current alcohol or other substance abuse
- chronic steroid use
- pre-existing chronic pain requiring chronic analgesic use
- history of seizure disorder requiring treatment with an anticonvulsant
- current therapy with thiazolidinedione class oral hypoglycemic agents (eg, Actos, Avandia or Avandamet)
- history of congestive heart failure
- major psychiatric disorder
- any contraindication to use of NSAIDs.
- Insufficient safety data in the patient population:
- patients requiring preoperative assistance or assistive device for ambulation, pregnant or breastfeeding
- weight \<50 Kg
- dizziness while inpatient.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00998816
Start Date
May 1 2012
End Date
October 1 2014
Last Update
April 11 2012
Active Locations (1)
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1
Dr. Jorge E Zamora
Kingston, Ontario, Canada, K7L 2V7