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

Phase 3

Withdrawn

• Conditions: Chronic Pain
• Interventions: Drug: Pregabalin

• Registration Number: NCT00998816
• Lead Sponsor: Queen's University

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 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.

Study Timeline

• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-11
• Study Start: 2012-05
• Primary Completion: 2014-08
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregabalin capsules	Pregabalin	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.
Placebo capsules	Pregabalin	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.

Primary Outcome Measures

Name	Time	Method
Incidence of chronic post thoracotomy pain syndrome	6 months following surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dr. Jorge E Zamora; 🇨🇦 Kingston, Ontario, Canada