Opioid-Sparing Joint Replacement
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
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 interventionMultimodal 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
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Opioid-Sparing RegimenExperimental treatment 2 interventions
Group B: Standard Opioid PrescriptionActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Daily Pain Scores (Numeric Rating Scale, NRS)
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.
Time frame
Postoperative Days 1-72
Opioid Consumption (Morphine Milligram Equivalents, MME)
Total opioid use, including study medication, rescue hydromorphone, and any additional prescriptions, will be converted to MME to quantify postoperative opioid consumption.
Time frame
1 week, 3 weeks, and 3 months postoperatively3
Pain-Related Contacts to Clinical Team
Number of calls or electronic messages to the surgical team related to pain management.
Time frame
Up to 3 months postoperatively4
Medication-Related Side Effects
Incidence and severity of nausea, constipation, vomiting, or other adverse effects associated with postoperative pain medications.
Time frame
Postoperative Days 1-7Secondary outcomes
1
Patient-Reported Outcomes (PROMs): HOOS Jr
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS Jr.): A validated 6-item questionnaire assessing hip pain and functional ability in patients undergoing hip arthroplasty. 0-100 (converted score) Interpretation: * Higher scores indicate better hip function and less pain. * Lower scores indicate greater disability or worse symptoms.
Time frame
Baseline (preoperative) and at 3 months2
Patient-Reported Outcomes (PROMs): EQ-5D (EuroQol-5 Dimensions)
A standardized measure of health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Includes a health VAS. Index values typically 0-1 High scores: better overall health status. Low scores: poorer health or greater impairment.
Time frame
Baseline (preoperative) and at 3 months3
Patient-Reported Outcomes (PROMs): Subjective Hip Value (SHV)
A single-item measure in which patients rate their hip function as a percentage of normal. * 0% = Completely nonfunctional hip * 100% = Completely normal hip Interpretation: * Higher percentages indicate better perceived hip function. * Lower percentages indicate worse perceived function.
Time frame
Baseline (preoperative) and at 3 months4
Patient-Reported Outcomes (PROMs): Pain Catastrophizing Scale (PCS)
A 13-item questionnaire assessing catastrophic thinking related to pain (rumination, magnification, helplessness). Used at baseline for eligibility. Score range 0-52 High scores: greater pain catastrophizing; scores \>29 indicate high catastrophizing. Low scores: minimal catastrophic thinking.
Time frame
Baseline (preoperative) and at 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov