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

Phase 3
Withdrawn
Conditions
Post-thoracotomy Pain
Interventions
Drug: Placebo
Registration Number
NCT00934193
Lead Sponsor
University of Kansas Medical Center
Brief Summary

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

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
GabapentinGabapentin-
Primary Outcome Measures
NameTimeMethod
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.6 Months
Secondary Outcome Measures
NameTimeMethod
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