The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome
Information source: Queen's University
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: Pregabalin (Drug)
Phase: Phase 3
Sponsored by: Queen's University
Official(s) and/or principal investigator(s):
Jorge E Zamora, MD, Principal Investigator, Affiliation: Queen's University/ Kingston General Hospital
Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the
likelihood of chronic post-thoracotomy pain syndrome (CPTPS).
Official title: A Multicenter Prospective Randomized Double-blind Placebo Controlled Trial Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of chronic post thoracotomy pain syndrome
Secondary outcome: 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
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.
Minimum age: 18 Years.
Maximum age: 75 Years.
- Elective open thoracotomy for primary thoracic surgery, understanding and provision
of written informed consent, ASA class I II or III
- 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.
Locations and Contacts
Dr. Jorge E Zamora, Kingston, Ontario K7L 2V7, Canada
Starting date: May 2012
Last updated: April 10, 2012