Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Wichita Medical Research & Education Foundation
Via Christi Regional Medical Center-St Francis Campus
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00934193
First received: July 6, 2009
Last updated: November 13, 2009
Last verified: November 2009
  Purpose

The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.


Condition Intervention Phase
Post-thoracotomy Pain
Drug: Gabapentin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gabapentin Drug: Gabapentin
Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.
Placebo Comparator: Placebo Drug: Placebo
Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.

Detailed Description:

This study is a prospective double blind randomized controlled trial evaluating the peri-operative use of gabapentin in the prevention or modulation of post-thoracotomy hyperalgesia. Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Undergoing non-cardiac thoracic surgeries
  • Patients determined to have impaired decisional capacity with respect to the provision of informed consent or prisoners will not be included in the study.

Exclusion Criteria:

  • Current gabapentin use or current treatment for neuropathic pain.
  • Pregnant or considering becoming pregnant.
  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: NCT00934193

Sponsors and Collaborators
University of Kansas
Wichita Medical Research & Education Foundation
Via Christi Regional Medical Center-St Francis Campus
Investigators
Principal Investigator: Sinisa Malinovic, MD Via Christi Regional Medical Center-St Francis Campus
  More Information

No publications provided

Responsible Party: Sinisa Malinovic MD and/or Bryan L. Black MD, Via Christi Regional Medical Center-St Francis Campus
ClinicalTrials.gov Identifier: NCT00934193     History of Changes
Other Study ID Numbers: 220081131, WMREF 80104-257
Study First Received: July 6, 2009
Last Updated: November 13, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gabapentin
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014