Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

Study Overview
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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.

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.

Official Title
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Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

Conditions
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Tibia Fracture, Femur Fracture, Humerus Fracture

Intervention / Treatment
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* Drug: Narcotics alone
* Drug: Narcotics and NSAIDS


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Narcotics alone|nan|
|Drug: Narcotics and NSAIDS|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score |  |  | 
| Amount of narcotics used |  |  | 
| time to fracture healing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| return to activity |  |  | 
| complications |  |  | 
| reoperation rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tibia, fracture, femur, humerus, narcotics, bimodal, analgesia, long-bone, NSAIDS