Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain? - Full Text View

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:

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

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.

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

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
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 21, 2013