Trial | NCT00934193  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    gabapentin ...

  • Study Participants

    0
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.
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 Started
Jul 31
2009
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Dec 16
2015
Estimate

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.

Gabapentin Active Comparator

Placebo Placebo Comparator

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.
No Results Posted