Opioid-Sparing Joint Replacement

Opioid-Sparing Joint Replacement - Single Site Randomized Control 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?

Study Overview

• Status: Recruiting
• Conditions: Pain Management; Opioid Consumption
• Intervention / Treatment: Drug: Placebo; Other: Multimodal Non-Opioid Analgesia; Drug: Oxycodone 5 mg

Detailed Description

This study evaluates whether an opioid-sparing postoperative regimen can reduce opioid use while maintaining effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. Although opioids are commonly used after joint replacement, they carry risks such as side effects and long-term dependence. Multimodal analgesic strategies-using combinations of non-opioid medications and local anesthetic techniques-have shown promise in reducing opioid requirements while providing adequate pain relief.

All participants in this randomized, double-blind trial will receive a standardized multimodal non-opioid pain regimen throughout the perioperative period, along with counseling from a Life Care Specialist. Participants will be assigned to receive either a standard opioid prescription or placebo tablets at discharge, with a small supply of rescue hydromorphone available for severe breakthrough pain. Pain scores, nausea, opioid consumption, and patient-reported outcomes will be collected during the first postoperative week and at follow-up visits at 3 weeks and 3 months. The study aims to determine whether limiting routine opioid prescribing after hip arthroplasty can safely reduce opioid exposure without compromising recovery or patient satisfaction.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ajay Premkumar, MD; Phone Number: 404-778-3350; Email: ajay.premkumar@emory.edu
• Study Contact Backup: Name: Darrell Favors; Email: darrell.favors@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Emory University Orthopedics and Spine Hospital
      • Contact: Ajay Premkumar, MD; Phone Number: 404-778-3350; Email: ajay.premkumar@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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; 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
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.	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative Days 1-7
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.	1 week, 3 weeks, and 3 months postoperatively
Pain-Related Contacts to Clinical Team	Number of calls or electronic messages to the surgical team related to pain management.	Up to 3 months postoperatively
Medication-Related Side Effects	Incidence and severity of nausea, constipation, vomiting, or other adverse effects associated with postoperative pain medications.	Postoperative Days 1-7
Opioid Prescription Refills	Number of opioid prescription refills requested or obtained after surgery.	Up to 3 months postoperatively
Patient Satisfaction With Pain Control	Patient-reported satisfaction with postoperative pain control, rated on a 5-point scale (much worse than expected to much better than expected).	1 week, 3 weeks, and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (preoperative) and at 3 months
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.	Baseline (preoperative) and at 3 months
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.	Baseline (preoperative) and at 3 months
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.	Baseline (preoperative) and at 3 months
Postoperative Nausea (VAS-Nausea)	Nausea severity recorded three times daily using a 0-10 Visual Analog Scale. A 0-10 scale used to measure severity of postoperative nausea. Recorded three times daily for 7 days. High scores: more severe nausea. Low scores: minimal or no nausea.	Postoperative Days 1-7
Sleep Quality and Pain-Related Satisfaction	A patient-reported measure assessing perceived sleep quality and satisfaction with pain management during the study period. Both items use a 0-10 Numeric Rating Scale (NRS).; Higher scores indicate better sleep quality and greater satisfaction with pain management.; Lower scores indicate poorer sleep quality and lower satisfaction.	Postoperative Days 1-7
Length of Stay (LOS)	Duration of postoperative hospitalization.	Day of surgery through discharge (usually upto 7 days)
Healthcare Utilization	Number of emergency department visits, readmissions, and reoperations related to the index surgery.	Up to 3 months postoperatively

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Ajay Premkumar, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Total hip arthroplasty; Numeric Rating Scale for pain; Visual Analog Scale for nausea; Life Care specialist
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Codeine; Oxycodone
• Other Study ID Numbers: 2025P011932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data underlying the primary and secondary outcomes of the study, including:

Daily postoperative pain scores (Numeric Rating Scale, POD 1-7) Opioid consumption data (oral morphine equivalents) at 7 days, 3 weeks, and 3 months Patient-reported outcome measures (HOOS Jr., EQ-5D, Subjective Hip Value) Patient-reported satisfaction with pain control Medication-related side effects (e.g., nausea, constipation) Opioid refill information Length of stay, emergency department visits, readmissions, and reoperations

• IPD Sharing Time Frame: Data will become available after publication of the primary study results and will remain available for up to 5 years following publication, contingent upon institutional data retention policies.

IPD Sharing Access Criteria

De-identified data will be shared with qualified researchers whose proposed use of the data has been approved by the study investigators.

Requests for data access must be submitted to the corresponding author. Approved requests will be granted through a secure data-sharing mechanism (e.g., encrypted file transfer or institutional data-sharing platform) following execution of a data use agreement, as required.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No