Opioid-Sparing Joint Replacement

Emory University

Status and phase: Not yet enrolling; Phase 3

Conditions: Pain Management; Opioid Consumption

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07348627

2025P011932

Details and patient eligibility

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.

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?

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Opioid-Sparing Regimen

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Other: Multimodal Non-Opioid Analgesia

Standard Opioid Prescription

Active Comparator group

Description:

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.

Treatment:

Drug: Oxycodone 5 mg

Other: Multimodal Non-Opioid Analgesia