NCT07348627 · Emory University
Opioid-Sparing Joint Replacement
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Placebo
* 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
Primary outcome measures
Daily Pain Scores (Numeric Rating Scale, NRS)
Time frame: 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)
Time frame: 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 Team
Time frame: Up to 3 months postoperatively
Number of calls or electronic messages to the surgical team related to pain management.
Medication-Related Side Effects
Time frame: Postoperative Days 1-7
Incidence and severity of nausea, constipation, vomiting, or other adverse effects associated with postoperative pain medications.
Opioid Prescription Refills
Time frame: Up to 3 months postoperatively
Number of opioid prescription refills requested or obtained after surgery.
Patient Satisfaction With Pain Control
Time frame: 1 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- 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
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2026 · Source of record for eligibility and locations