Opioid-Sparing Joint Replacement

NCT07348627 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2025P011932
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Pain Management; Opioid Consumption

Keywords

Total hip arthroplasty; Numeric Rating Scale for pain; Visual Analog Scale for nausea; Life Care specialist

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Patient-Reported Outcomes (PROMs): HOOS Jr

  Baseline (preoperative) and at 3 months

• Patient-Reported Outcomes (PROMs): EQ-5D (EuroQol-5 Dimensions)

  Baseline (preoperative) and at 3 months

• Patient-Reported Outcomes (PROMs): Subjective Hip Value (SHV)

  Baseline (preoperative) and at 3 months

• Patient-Reported Outcomes (PROMs): Pain Catastrophizing Scale (PCS)

  Baseline (preoperative) and at 3 months

• Postoperative Nausea (VAS-Nausea)

  Postoperative Days 1-7

Study Arms (2)

Opioid-Sparing Regimen

EXPERIMENTAL

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; Other: Multimodal Non-Opioid Analgesia

Standard Opioid Prescription

ACTIVE COMPARATOR

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.

Drug: Oxycodone 5 mg; Other: Multimodal Non-Opioid Analgesia

Interventions

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

Opioid-Sparing Regimen

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

Standard Opioid Prescription

Multimodal Non-Opioid Analgesia OTHER

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

Opioid-Sparing Regimen; Standard Opioid Prescription

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Orthopedics and Spine Hospital

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ajay Premkumar, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay Premkumar, MD

CONTACT

404-778-3350; ajay.premkumar@emory.edu

Darrell Favors

CONTACT

darrell.favors@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 16, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)