Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty

Study Overview
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Brief Summary
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This is a prospective, three-arm, comparative study with a provider-crossover design. The first arm will comprise the standard of care pain regimen after discharge, which comprises PRN oxycodone, tramadol, and acetaminophen. The second arm will comprise a multimodal pain regimen; however, patients will still be routinely provided PRN oxycodone and tramadol to use on an as needed basis. The third arm will comprise a multimodal pain management protocol, which does not routinely allow for opioid consumption. However, patients will be provided a one week supply of oxycodone and tramadol for emergency pain relief only.

Official Title
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Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Drug: Multi-modal with as needed opioids
* Drug: Multi-modal with one week of opioids offered
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral, primary cementless THA with underlying diagnosis of osteoarthritis. ASA I - III Spinal anesthesia Male and Female over 18 who are willing and able to provide informed consent Exclusion Criteria: Opioid use within 3 months prior to surgery General anesthesia Non-english speaking ASA IV or greater Allergy/contraindications to protocol medications Renal insufficiency with Cr > 2.0 or hepatic failure Sensory/motor disorder involving the operative limb Planned or unplanned discharge to rehab Length of stay >3 days Revision or conversion THA Cigarette smokers

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br> | Drug: Standard of Care<br>* This arm follows standard of care post-operative pain management with oxycodone, tramadol, and acetametophin<br>|
| Active Comparator: Multi-modal with as needed opioids<br> | Drug: Multi-modal with as needed opioids<br>* Multi-modal with as needed oxycodone and tramadol provided for break-through pain<br>|
| Active Comparator: Multi-modal with one week of opioids offered<br> | Drug: Multi-modal with one week of opioids offered<br>* Multi-modal with only one week of oxycodone and tramadol provided for emergency pain relief only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total opioid consumption |  | total consumption calcuated from surgery date through 30 days post-op | 
| Pain | Pain as reported by Visual Analog Scale | 30 days post-operative |