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

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

Detailed Description
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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 12 hr for an additional 10 days. While in the hospital, patients will be assessed for pain intensity, satisfaction and side effects. Patients will be re-assessed at 2, 4 and 6 months following surgery.

Official Title
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A Multicenter Prospective Randomized Double-blind Placebo Controlled Trial Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo capsules<br>one placebo capsule will be administered 1 hour before lateral thoracotomy, 12 hours following the thoracotomy and then every 12h BID for 10 days following lateral thoracotomy. | Drug: Pregabalin<br>* pregabalin capsules (150mg,oral) will be administered 1 hour before lateral thoracotomy, 12 hours after the thoracotomy and then 12 h BID for 10 additional days.<br>* Other names: Lyrica;|
| Active Comparator: pregabalin capsules<br>Pregabalin capsules (150mg) will be administered one hour before lateral thoracotomy, 12 hours following the thoracotomy and then every 12 hours (BID) for 10 days following lateral thoracotomy. | Drug: Pregabalin<br>* pregabalin capsules (150mg,oral) will be administered 1 hour before lateral thoracotomy, 12 hours after the thoracotomy and then 12 h BID for 10 additional days.<br>* Other names: Lyrica;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chronic post thoracotomy pain syndrome |  | 6 months following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| During hospital stay: pain intensity, PEF and FEV1, patient satisfaction, medication side effects. At 2, 4, and 6 months: pain intensity, pain quality (neuropathic versus other), quality of life, pain interference with daily function |  | During hospital stay and at 2, 4, and 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracotomy, chronic, pain, pregabalin, Lyrica