Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT00934193
Status:
WITHDRAWN
Last Update Posted:
2015-12-16
First Post:
2009-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| WMREF 80104-257 | OTHER | WMREF IRB | View |