Opioid-Sparing Joint Replacement
NCT07348627 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-04-17
Summary
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
Interventions
- 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
- DRUG
-
Oxycodone 5 mg
* 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
- OTHER
-
Multimodal Non-Opioid Analgesia
Multimodal 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
Sponsors & Collaborators
-
Emory University
lead OTHER
Principal Investigators
-
Ajay Premkumar, MD · Emory University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-19
- Primary Completion
- 2028-08-31
- Completion
- 2028-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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