RecruitingPhase 3NCT07348627

Opioid-Sparing Joint Replacement

Opioid-Sparing Joint Replacement - Single Site Randomized Control Trial


Sponsor

Emory University

Enrollment

120 participants

Start Date

Mar 19, 2026

Study Type

INTERVENTIONAL

Conditions

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?


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria14

  • 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

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Interventions

DRUGPlacebo

* 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

DRUGOxycodone 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

OTHERMultimodal 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


Locations(1)

Emory University Orthopedics and Spine Hospital

Atlanta, Georgia, United States

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NCT07348627


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