Pregabalin and Post-Thoracotomy Pain - Full Text View

Sponsored by:	Queen's University
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00663962

Purpose

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.

Condition	Intervention	Phase
Chronic Thoracotomy Pain	Drug: Pregabalin Drug: Placebo	Phase IV

Drug Information available for: Pregabalin

U.S. FDA Resources

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

Further study details as provided by Queen's University:

Primary Outcome Measures:

The primary outcome measure for the final study will be the incidence of CPTPS at 2 months. [ Time Frame: 2, 4, and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	April 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PHASE 1 (N=7) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=8) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.	Drug: Pregabalin PHASE 1 (N=7) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=8) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
2: Placebo Comparator An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.	Drug: Placebo An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663962

Contacts

Contact: Jorge E Zamora, MD	613-548-7827	zamoraj@kgh.kari.net
Contact: Kim E Turner, MD	613-548-7827	turnerk@kgh.kari.net

Locations

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

Sponsors and Collaborators

Queen's University

Investigators

Principal Investigator:

Jorge E Zamora, MD

Department of Anesthesiology Queen's University

More Information

Responsible Party:	Department of Anesthesiology, Queen's University ( Dr. Jorge Enrique Zamora )
Study ID Numbers:	ANAE-139-08
Study First Received:	April 18, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00663962
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Queen's University:

Pain
Thoracotomy
Post-surgical
Pregabalin

Study placed in the following topic categories:

Pregabalin
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009