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 — OTHER
    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

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 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.

Primary Outcome Measure

Daily Pain Scores (Numeric Rating Scale, NRS) [ Time Frame: Postoperative Days 1-7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Orthopedics and Spine HospitalAtlantaGeorgia30329
Ajay Premkumar, MD
404-778-3350

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