Opioid-Sparing Joint Replacement Study

This study is looking at whether a pain management plan that uses fewer opioids (pain medications like oxycodone) can still effectively control pain after total hip replacement surgery for osteoarthritis. All participants will receive a standard non-opioid pain regimen, including medications like acetaminophen and meloxicam, along with spinal anesthesia and local anesthetic injections. Some participants will also receive 5 mg oxycodone tablets, while others will receive identical-looking placebo tablets. The researchers want to see if limiting routine opioid prescriptions can reduce how much opioid medication you use without making your pain worse or affecting your satisfaction. You might be able to join if you are an adult having total hip replacement surgery for hip osteoarthritis and can follow study procedures. The study will measure your daily pain, how much opioid medication you use, and how often you contact your care team about pain for up to three months after surgery. The current recruitment status is unclear.

Study design
This is a randomized, double-blind study, meaning participants are randomly assigned to a treatment group and neither you nor your doctors will know which treatment you are receiving. It plans to enroll 120 participants.
What's involved
You will receive a standardized pain regimen and counseling. Your pain scores, nausea, opioid use, and other outcomes will be collected during the first week after surgery and at follow-up visits at 3 weeks and 3 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 months after surgery to assess pain-related contacts to the clinical team.

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NCT07348627

Opioid-Sparing Joint Replacement

Recruiting
PHASE3Ages 18+InterventionalTreatment
Emory University
~120 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:PlaceboOxycodone 5 mgMultimodal Non-Opioid Analgesia

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Daily Pain Scores (Numeric Rating Scale, NRS)
Measured over Postoperative Days 1-7
+5 more outcomes measured
Pain Management
Opioid Consumption
1 sites across 1 states
Georgia1
  • Ajay Premkumar, MD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

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

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
  • Daily Pain Scores (Numeric Rating Scale, NRS)Postoperative Days 1-7

    A 0-10 numeric scale used to assess pain intensity. Participants rate their pain three times daily during the first postoperative week. Mean daily pain scores will be compared between groups. High scores: greater pain intensity. Low scores: better pain control.

  • Opioid Consumption (Morphine Milligram Equivalents, MME)1 week, 3 weeks, and 3 months postoperatively

    Total opioid use, including study medication, rescue hydromorphone, and any additional prescriptions, will be converted to MME to quantify postoperative opioid consumption.

  • Pain-Related Contacts to Clinical TeamUp to 3 months postoperatively

    Number of calls or electronic messages to the surgical team related to pain management.

  • Medication-Related Side EffectsPostoperative Days 1-7

    Incidence and severity of nausea, constipation, vomiting, or other adverse effects associated with postoperative pain medications.

  • Opioid Prescription RefillsUp to 3 months postoperatively

    Number of opioid prescription refills requested or obtained after surgery.

  • Patient Satisfaction With Pain Control1 week, 3 weeks, and 3 months

    Patient-reported satisfaction with postoperative pain control, rated on a 5-point scale (much worse than expected to much better than expected).