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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Wichita Medical Research & Education Foundation
Via Christi Regional Medical Center-St Francis Campus
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00934193
First received: July 6, 2009
Last updated: December 15, 2015
Last verified: December 2015
  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 Medical Center:

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 ]

Enrollment: 0
Study Start Date: July 2009
Study Completion Date: June 2011
Primary Completion Date: June 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   (Adult, Senior)
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 Medical Center
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

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00934193     History of Changes
Other Study ID Numbers: 220081131  WMREF 80104-257 
Study First Received: July 6, 2009
Last Updated: December 15, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 25, 2016