NCT07348627

Opioid-Sparing Joint Replacement

Opioid-Sparing Joint Replacement - Single Site Randomized Control Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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
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

Timeline

• Start date: 2026-03-19
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2026-01-16
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study