The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome

• Status: Withdrawn
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (CPTPS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Collaborator: McMaster University
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Elective open thoracotomy for primary thoracic surgery, understanding and provision of written informed consent, ASA class I II or III

Exclusion Criteria:

• 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.