Pregabalin and Post-thoracotomy Pain
This trial is active, not recruiting.
|Conditions||chronic, thoracotomy, pain|
|Start date||April 2008|
|End date||May 2009|
|Trial size||15 participants|
|Trial identifier||NCT00663962, ANAE-139-08|
Chronic post thoracotomy pain syndrome (CPTPS) is a significant problem that has important effects on patients' daily activities. The severity of postoperative pain and the central sensitization associated with it are thought to play a role in the chronification of acute pain. Gabapentin has been shown to be effective in reducing acute post-surgical pain and treating CPTPS. There is conflicting data regarding its effects on the development of chronic post-surgical pain. Although pregabalin is similar to gabapentin there are only a few studies examining its use in the modification of post-surgical pain but evidence suggests that it might be effective. There are no studies examining the effect of pregabalin on the development of chronic post-surgical pain. Our hypothesis is that perioperative use of pregabalin will decrease the incidence of CPTPS. Our ultimate goal is to conduct a multi-center study assessing the effect of perioperative oral pregabalin on the development of CPTPS. Prior to this, we will carry out a prospective, randomized, placebo controlled, double-blinded pilot study to assess the feasibility, safety, and compliance associated with perioperative use of oral pregabalin in patients undergoing video assisted thoracotomy surgery (VATS) or open thoracotomy procedures.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
The primary outcome measure for the final study will be the incidence of CPTPS at 2 months.
time frame: 2, 4, and 6 months
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - Elective thoracotomy (ET) or video assisted thoracotomy (VAT); - Understanding and provision of written informed consent; - Age > 18 and < 75; - ASA class I, II or III. Exclusion Criteria: - Inability to adhere to study protocol; - Intolerance or known hypersensitivity to any agents to be used in the study; - Contraindication to thoracic epidural placement in open thoracotomy patients; - Inability to respond to the study questionnaire; - Renal insufficiency (serum creatinine > 1.5 x upper limit of normal); - BMI > 40; - Confounding procedural factors which might affect validity of data; - Surgery for tumour extending into the chest wall; - Requirement for second thoracotomy or re-occurrence of disease after surgery; - Potential interaction with study medications and patient's current medications; - Current ETOH or substance abuse; - Pre-existing chronic pain requiring chronic analgesic use; - History of seizure disorder requiring treatment with an anti-convulsant; - Current therapy with thiazolidinedione class oral hypoglycemic agents (e.g. Actos, Avandia, or Avandamet); - History of congestive heart failure; - Major psychiatric disorder; - Insufficient safety data in a specific patient population; - Pregnant or breastfeeding.
|Official title||A Prospective, Randomized, Double Blinded, Placebo Controlled Pilot Study Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome|
|Principal investigator||Jorge E Zamora, MD|
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