Comparing Perioperative Outcomes in Pain Control

Study Overview
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Brief Summary
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This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an orthopaedic injury requiring surgery. Patients who consent to study participation will be randomized to receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management. Data on opioid usage, pain control, and functional status will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight in determining appropriateness of pain regimens that reduce the overall opioid consumption. Given the widespread opioid epidemic, it is imperative to develop alternative means to appropriately manage pain in orthopaedic surgery patients.

Official Title
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Randomized Controlled Trial Comparing Multimodal Pain Protocol Versus Hydrocodone-Acetaminophen for Post-Operative Pain Management in Orthopaedic Surgery Patients

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Orthopaedic injury requiring surgery Evaluation and treatment at UCSD Age 18years or older Ability to understand the content of the patient information/Informed Consent Form Signed and dated Institutional Review Board (IRB) approved written informed consent Exclusion Criteria: Polytrauma Any not medically managed severe systemic disease Their doctor has decided that it is in the patient's best interest to receive pain management regimen of one type vs. the other. The patient prefers one type of pain management protocol and is not willing to be randomized. Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment or confound pain control Pregnancy or women planning to conceive within the subject participation period (1 year) o Pregnancy will be self-reported and no test will be performed to test for it. Prisoner Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard oral hydrocodone-acetaminophen post-op management<br> | |
| Active Comparator: Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)<br> | Drug: Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)<br>* Multimodal Pain Management to minimize patients' reliance on opioids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine equivalents used | Morphine equivalents used over 1 year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score (0-10, 0=no pain, 10=most severe pain) |  | 1 year | 
| Number of Complications |  | 1 year |