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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Pregabalin

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Dr. Jorge E Zamora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo capsules; 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; 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.; Other Names: Lyrica
Active Comparator: pregabalin capsules; 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; 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.; Other Names: Lyrica

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: McMaster University
• Investigators: Principal Investigator: Jorge E Zamora, MD, Queen's University/ Kingston General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: October 20, 2009
• First Submitted That Met QC Criteria: October 20, 2009
• First Posted (Estimate): October 21, 2009

Study Record Updates

• Last Update Posted (Estimate): April 11, 2012
• Last Update Submitted That Met QC Criteria: April 10, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: pain; pregabalin; chronic; thoracotomy; Lyrica
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: ANAE 153-09