Opioid-Sparing Joint Replacement
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Emory University
- Study ID
- NCT07348627
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Opioid Consumption
- Pain Management
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Placebo — DRUG* 28 tablets identical in appearance to 5-mg oxycodone * Taken 1-2 tablets every 4 hours as needed for moderate to severe pain * Dispensed by Investigational Drug Services * Used in combination with standardized multimodal analgesia
- Oxycodone 5 mg — DRUG* 28 tablets of 5-mg oxycodone * Taken 1-2 tablets every 4 hours as needed for moderate to severe pain * Represents standard postoperative prescribing practi
- Multimodal Non-Opioid Analgesia — OTHERMultimodal Non-Opioid Analgesia (Standardized Regimen) Includes: * Acetaminophen * Meloxicam * Methylprednisolone taper * Spinal anesthesia * Periarticular local anesthetic injection * Postoperative scheduled acetaminophen and NSAIDs * Counseling by Life Care Specialist * Two 2-mg hydromorphone tablets for rescue only
Study Details
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?
Key Dates
- Start date
- Mar 19, 2026
- Status verified
- Apr 2026
- Primary completion
- Aug 31, 2028
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Opioid-Sparing RegimenParticipants 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 PrescriptionParticipants 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.
Primary Outcome Measure
Daily Pain Scores (Numeric Rating Scale, NRS) [ Time Frame: Postoperative Days 1-7 ]
Central Contacts
- Ajay Premkumar, MD404-778-3350
- Darrell Favors
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory University Orthopedics and Spine Hospital | Atlanta | Georgia | 30329 |
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