Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-09-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tibia Fracture Femur Fracture Humerus Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Narcotics alone

Intervention Type DRUG

Narcotics and NSAIDS

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No