The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome
WithdrawnPhase 3NCT00998816
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Brief summary (from the registry)
Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (CPTPS).
Study details
- 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
- Conditions
- Interventions
- Sponsor
- Queen's University
- Collaborators
- McMaster University
- Start date
- 2012-05
- Primary completion
- 2014-08
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00998816