Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240396
Status:
WITHDRAWN
Last Update Posted:
2017-03-22
First Post:
2005-10-14
Brief Title:
Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture
Status:
WITHDRAWN
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We were not able to enroll patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this prospective randomized study is to evaluate the risks and benefits of using bimodal analgesia ie Narcotics and NSAIDS vs Narcotics alone post long bone fracture
Detailed Description:
This will be a prospective randomized control trial looking at the benefit of bimodal analgesia in the treatment of long bone fractures The traditional pain control regimen following fracture fixation typically involves a course of narcotics on an as-needed basis for pain relief Recent data has shown that adding NSAIDS to the pain regimen as part of a bimodal approach to pain control improves the efficacy of pain management and reduces narcotic use Laboratory research on NSAIDs as it pertains to bone healing however has shown in animal models that there may be a positive association between NSAIDS and non-union rates In other words NSAIDS may prevent or delay bone healing These results however have not been tested prospectively in humans
The purpose of this study is to look at the combination of NSAIDS and narcotics post long bone fracture and monitor the effects on narcotic use and healing rates to ultimately and conclusively establish the risk or benefit of NSAIDS after long bone fracture
The purpose of this study is to look at the combination of NSAIDS and narcotics post long bone fracture and monitor the effects on narcotic use and healing rates to ultimately and conclusively establish the risk or benefit of NSAIDS after long bone fracture
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None