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Pregabalin and Post-thoracotomy Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Jorge Zamora, Queen's University
ClinicalTrials.gov Identifier:
NCT00663962
First received: April 18, 2008
Last updated: January 29, 2016
Last verified: January 2016
  Purpose
With Institutional Ethics Board approval and signed informed consent, a pilot investigation was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoperatively and 7 days postoperatively (BID) or 3) placebo for same regimen to assess the feasibility, safety and compliance of this drug regimen on this patient population. This assessment was necessary in order to plan a future fully powered randomized controlled trial looking at the efficacy of perioperative pregabalin ifor reducing the incidence/severity of chronic post-thoracotomy pain.

Condition Intervention Phase
Chronic Pain
Drug: Pregabalin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]
  • Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively [ Time Frame: 2 months postoperatively ] [ Designated as safety issue: No ]
    Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale)


Enrollment: 15
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perioperative pregabalin
Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=3) or Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=4).
Drug: Pregabalin

PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.

PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.

Placebo Comparator: Placebo control
An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
Drug: Placebo
An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op (N=8)

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L2V7
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Jorge E Zamora, MD Department of Anesthesiology Queen's University
  More Information

Responsible Party: Dr. Jorge Zamora, MD, Queen's University
ClinicalTrials.gov Identifier: NCT00663962     History of Changes
Other Study ID Numbers: ANAE-139-08 
Study First Received: April 18, 2008
Results First Received: January 31, 2013
Last Updated: January 29, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Queen's University:
Thoracotomy
Post-surgical
Pregabalin

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 28, 2016