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

NCT00934193 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-12-16

No results posted yet for this study

Summary

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

Conditions

  • Post-thoracotomy Pain

Interventions

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.

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.

Sponsors & Collaborators

  • Wichita Medical Research and Education Foundation

    collaborator OTHER

  • Ascension Via Christi Hospitals Wichita, Inc.

    collaborator OTHER

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Sinisa Malinovic, MD · Ascension Via Christi Hospitals Wichita, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-06-30
Completion
2011-06-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00934193 on ClinicalTrials.gov