Pregabalin and Post-thoracotomy Pain
Information source: Queen's University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic; Thoracotomy; Pain
Intervention: Pregabalin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Queen's University
Official(s) and/or principal investigator(s):
Jorge E Zamora, MD, Principal Investigator, Affiliation: Department of Anesthesiology Queen's University
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.
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The primary outcome measure for the final study will be the incidence of CPTPS at 2 months.
Minimum age: 18 Years.
Maximum age: 75 Years.
- 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.
- 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.
Locations and Contacts
Kingston General Hospital, Kingston, Ontario K7L2V7, Canada
Starting date: April 2008
Last updated: September 18, 2009