Pregabalin and Post-Thoracotomy Pain

Condition(s) targeted: Chronic; Thoracotomy; Pain

Intervention: Pregabalin (Drug); Placebo (Drug)

Phase: Phase 4

Status: 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

Overall contact:
Jorge E Zamora, MD, Phone: 613-548-7827, Email: zamoraj@kgh.kari.net

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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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. Gender(s): Both.

Criteria:

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.

Jorge E Zamora, MD, Phone: 613-548-7827, Email: zamoraj@kgh.kari.net

Kingston General Hospital, Kingston, Ontario K7L2V7, Canada; Recruiting
Jorge E Zamora, MD, Phone: 613-548 7827, Email: zamoraj@kgh.kari.net
Kim E Turner, MD, Phone: 613-548 7827, Email: turnerk@kgh.kari.net

Starting date: April 2008
Ending date: May 2010
Last updated: September 8, 2008