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

Post-thoracotomy Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00934193
• Other study ID #: 220081131
• Secondary ID: WMREF 80104-257
• Status: Withdrawn
• Phase: Phase 3
• First received: July 6, 2009
• Last updated: December 15, 2015
• Start date: July 2009
• Est. completion date: June 2011

Study information

• Verified date: December 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Post-thoracotomy Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Via Christi Regional Medical Center-St Francis Campus, Wichita Medical Research & Education Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.		6 Months	No