Opioid-Sparing Joint Replacement
Purpose
The goal of this clinical trial is to evaluate whether an opioid-sparing postoperative pain regimen can reduce opioid consumption and maintain effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. The main questions it aims to answer are: - Does an opioid-limited regimen result in lower postoperative opioid use compared with a standard opioid prescription? - Does the opioid-limited regimen provide comparable or improved postoperative pain control and patient satisfaction?
Conditions
- Pain Management
- Opioid Consumption
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of hip osteoarthritis requiring primary arthroplasty - Scheduled to undergo anterior total hip arthroplasty (THA) - Able to comply with study procedures and follow-up visits - Able to provide informed consent
Exclusion Criteria
- Concurrent significant injuries to other bones or organs - Local infection at or near the surgical site - Preoperative opioid use within 4 weeks prior to surgery - History of severe heart disease (NYHA Class II or higher), renal failure, or liver dysfunction - Chronic liver disease - Neurological or psychiatric conditions that may influence pain perception - Pregnancy - History of alcohol or medication abuse - Inability to take NSAIDs - Use of postoperative DVT prophylaxis other than aspirin 81 mg twice daily - Diabetes mellitus with HbA1c > 8.0% - Diagnosis of chronic pain syndrome or fibromyalgia - Pain Catastrophizing Scale (PCS) score > 29 - Any condition that, in the investigator's judgment, may interfere with adherence to study procedures or follow-up
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Opioid-Sparing Regimen |
Participants receive a standardized multimodal non-opioid analgesic regimen throughout the perioperative period and are discharged with placebo tablets instead of a standard opioid prescription. All participants receive counseling from a Life Care Specialist and a limited supply of rescue hydromorphone for severe breakthrough pain. |
|
|
Active Comparator Standard Opioid Prescription |
Participants receive the same standardized multimodal non-opioid analgesic regimen and Life Care Specialist counseling as the experimental group, but are discharged with a standard opioid prescription. |
|
Recruiting Locations
Atlanta, Georgia 30329
More Details
- Status
- Recruiting
- Sponsor
- Emory University
Detailed Description
This study evaluates whether an opioid-sparing postoperative regimen can reduce opioid use while maintaining effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. Although opioids are commonly used after joint replacement, they carry risks such as side effects and long-term dependence. Multimodal analgesic strategies-using combinations of non-opioid medications and local anesthetic techniques-have shown promise in reducing opioid requirements while providing adequate pain relief. All participants in this randomized, double-blind trial will receive a standardized multimodal non-opioid pain regimen throughout the perioperative period, along with counseling from a Life Care Specialist. Participants will be assigned to receive either a standard opioid prescription or placebo tablets at discharge, with a small supply of rescue hydromorphone available for severe breakthrough pain. Pain scores, nausea, opioid consumption, and patient-reported outcomes will be collected during the first postoperative week and at follow-up visits at 3 weeks and 3 months. The study aims to determine whether limiting routine opioid prescribing after hip arthroplasty can safely reduce opioid exposure without compromising recovery or patient satisfaction.