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

Queen's University

Status and phase: Withdrawn; Phase 3

Conditions: Chronic Pain

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT00998816

ANAE 153-09

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo capsules

Placebo Comparator group

Description:

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.

Treatment:

Drug: Pregabalin

pregabalin capsules

Active Comparator group

Description:

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.

Treatment:

Drug: Pregabalin