Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

Not Applicable

Withdrawn

• Conditions: Femur Fracture; Humerus Fracture; Tibia Fracture

• Registration Number: NCT00240396
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

The purpose of this prospective randomized study is to evaluate the risks and benefits of using bimodal analgesia, (i.e. 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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Primary Completion: 2007-09-24
• Study Completion: 2007-09-24
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• skeletally mature patients over the age of 18 years
• Fracture of Tibia, femur, or Humerus.

Exclusion Criteria

• Open fractures grade III
• Open fractures with suspected compartment syndrome
• history of prior fracture in particular limb.
• Concurrent usage of Steroid drugs, and immunosuppressants.
• Prior or current history of GI bleeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
time to fracture healing
pain score
Amount of narcotics used

Secondary Outcome Measures

Name	Time	Method
return to activity
reoperation rate
complications

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States