Clinical trial NCT00998816: The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Chronic Pain
Keywords: thoracotomy
chronic
pain
pregabalin
Lyrica
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2009-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of chronic post thoracotomy pain syndrome
timeFrame: 6 months following surgery
Secondary outcomes:
measure: 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
timeFrame: During hospital stay and at 2, 4, and 6 months postoperatively
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Dr. Jorge E Zamora
state: Ontario
Study officials:
affiliation: Queen's University/ Kingston General Hospital
name: Jorge E Zamora, MD
role: PRINCIPAL_INVESTIGATOR
References: