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

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

Study Overview

• Status: Withdrawn
• Conditions: Post-thoracotomy Pain
• Intervention / Treatment: Drug: Gabapentin; Drug: Placebo

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.

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.	6 Months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Wichita Medical Research and Education Foundation; Ascension Via Christi Hospitals Wichita, Inc.
• Investigators: Principal Investigator: Sinisa Malinovic, MD, Ascension Via Christi Hospitals Wichita, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 6, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 220081131; WMREF 80104-257 (Other Identifier: WMREF IRB)