Opioid-Sparing Joint Replacement

NCT ID: NCT07348627

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-08-31

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?

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.

Conditions

Pain Management; Opioid Consumption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: 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

Multimodal Non-Opioid Analgesia

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Oxycodone 5 mg

Intervention Type: 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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ajay Premkumar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ajay Premkumar, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Orthopedics and Spine Hospital

Atlanta, Georgia, United States

Countries

United States

Central Contacts

Ajay Premkumar, MD

Role: CONTACT

ajay.premkumar@emory.edu

404-778-3350

Darrell Favors

Role: CONTACT

darrell.favors@emory.edu

Facility Contacts

Ajay Premkumar, MD

Role: primary

ajay.premkumar@emory.edu

404-778-3350

Other Identifiers

2025P011932

Identifier Type: -

Identifier Source: org_study_id