NSAIDS Versus Opioids in Acute SER II Ankle Fractures

Study Overview
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Brief Summary
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This study is being conducted to evaluate whether NSAIDS are more or less effective in bone healing than opioids in acute fracture pain. Participants will be randomized to one of three groups for first line treatment of pain related to the fracture.

Detailed Description
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Pain management in acute fractures is challenging and influenced by several factors contributing to pain perception. These factors include but are not limited to tissue damage by the local impact, mechanical stress at the fracture ends, and central perception of the noxious stimulus. Tissue damage and mechanical stress leads to inflammation and further to local swelling. Swelling itself is significant contributor in pain development. Ideal pain management would attack pain development at most sites possible. The current clinical practice in the US applies a derivate of an opioid analgesic combined with acetaminophen, thereby influencing pain development at central perception by the opioid analgesic and acetaminophen and a peripheral analgesic effect of acetaminophen. The exact mechanism of the peripheral effect is not known. This clinical practice disregards the positive effect of medications influencing the peripheral inflammatory response, namely nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs affect pain development by blocking the synthesis of arachidonic acid metabolites, inhibiting peripheral inflammatory response and central pain perception. The major reason for not applying NSAIDs in the treatment of acute fracture pain is an experimental animal study showing decreased bone healing in relation to NSAID usage. However, clinical data thus far is inconclusive, whether bone healing is affected in humans and whether NSAIDs should be avoided in the setting of bone fractures. This proposed study will give an answer whether the usage of NSAIDs in acute fractures has a negative effect on bone healing.

Official Title
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Pain Management With NSAIDS in Acute Ankle Fractures Type Supination, External Rotation (SER) II: A Prospective Randomized, Single Blinded Controlled Study

Conditions
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Ankle Fracture

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Acetaminophen/hydrocodone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 to < 60 Isolated ankle fracture type SER II Ability to speak and understand English BMI< 35 Exclusion Criteria: ASA>3 Previous or acute gastric bleeding Renal insufficiency (Creatinine: >1.27mg/dl) Liver insufficiency (Child-Pugh-Wert: 10-15) Malignant tumor Rheumatoid arthritis Heart failure (NYHA III-IV) High frequency absolute arrhythmia Patients with known psychiatric illness Coagulopathy Asthma Function limiting disease of the lower extremity, besides what is mentioned in the inclusion criteria Adults unable to consent Pregnant women Prisoners Workers Comp patient Early fracture displacement (within first 2 weeks) indicating need for surgery Polytrauma Concurrent participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen 400 mg<br>Ibuprofen 400 mg po q 8 hours as needed (PRN) for pain. Subjects will receive Norco, 5/525 mg po q 6 hours PRN if pain relief with Ibuprofen is not sufficient. | Drug: Ibuprofen<br>* Ibuprofen 400 mg and 800 mg<br>* Other names: Motrin;|
| Active Comparator: Ibuprofen 800 mg<br>Ibuprofen 800 mg po q 8 hours PRN pain. Subjects will receive Norco, 5/525 mg po q 6 hours PRN if pain relief with Ibuprofen is not sufficient. | Drug: Ibuprofen<br>* Ibuprofen 400 mg and 800 mg<br>* Other names: Motrin;|
| Active Comparator: Norco<br>Norco (acetaminophen/hydrocodone) 10/325 mg po q 6 hours PRN pain. If pain is not relieved, physician should be contacted. | Drug: Acetaminophen/hydrocodone<br>* Norco 5/325 mg and 10/325 mg<br>* Other names: Norco;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fracture healing as measured by radiographic evaluation | fracture healing at 12 weeks followup | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain level improvement as measured by VAS score | VAS score | 1 week, 2 weeks, 6 weeks, 9 weeks and 12 weeks | 
| functional improvement as measured by AAOS score | AAOS scale | 1 weeks, 2 weeks 6 weeks, 9 weeks and 12 weeks |