NSAIDS vs Opioids in Tibial Fractures

Study Overview
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Brief Summary
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This study will attempt to determine if there is a statistic difference between the time to union, non-union rate and post-operative pain of patients who receive opioids for pain control vs. patients who receive NSAIDs and a reduced dosage of opioids for pain management

Detailed Description
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The study will be a prospective interventional study with two randomized parallel groups. Randomization will take place immediately following the identification of a potential participant. The control group will receive the standard of care for diaphyseal tibia fractures. The standard of care consists of intramedullary nailing and post-operative opioids for pain control. The interventional group will have the same surgical indication and intervention but will differ in the primary method of pain control. The study group will receive NSAIDs and a reduced dosage of opioids for pain control. Primary outcome measures will be time to union, non-union, and pain over the post-operative period measured by a VAS pain scale. Once the data collection of both groups is complete, the statistical analysis will begin to determine if there is a statistical difference between the control and study groups in the primary outcome measurements.

Official Title
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NSAIDs and Time to Union in Diaphyseal Tibia Fractures: Do NSAIDs Make a Difference

Conditions
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Trauma

Intervention / Treatment
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* Drug: NSAIDs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18 and 105 Diaphyseal tibia fracture (OTA/AO 42 A, B) Exclusion Criteria: -Tibial fractures not treated with intramedullary nails

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 105 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
Interventional Model Description: The study will be a prospective interventional study with two randomized parallel groups. Randomization will take place immediately following the identification of a potential participant. The control group will receive the standard of care for diaphyseal tibia fractures. The standard of care consists of intramedullary nailing and post-operative opioids for pain control. The interventional group will have the same surgical indication and intervention but will differ in the primary method of pain control. The study group will receive NSAIDs and a reduced dosage of opioids for pain control. Primary outcome measures will be time to union, non-union, and pain over the post-operative period measured by a VAS pain scale. Once the data collection of both groups is complete, the statistical analysis will begin to determine if there is a statistical difference between the control and study groups in the primary outcome measurements
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSAIDs<br>This arm is given NSAIDs perioperatively and after discharge | Drug: NSAIDs<br>* The patients will be given NSAIDs with a reduced dose of the standard opioids treatment.<br>* Other names: Ibuprofen;|
| No Intervention: Opioids<br>This arm will be given the standard opioids treatment to control pain perioperatively and at discharge. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to union | The time from surgery to bone healing | through study completion, an average of 1 year |