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

University of Kansas logo

University of Kansas

Status and phase

Withdrawn
Phase 3

Conditions

Post-thoracotomy Pain

Treatments

Drug: Gabapentin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00934193
220081131
WMREF 80104-257 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups, including a placebo group

Gabapentin
Active Comparator group
Treatment:
Drug: Gabapentin
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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