Non-Opioid Analgesia for Pain Management

Overseen By Darrell Favors

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Emory University

Must not be taking: Opioids, NSAIDs alternatives

Disqualifiers: Severe heart disease, Renal failure, Liver dysfunction, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this 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?

Who Is on the Research Team?

Ajay Premkumar, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults with hip osteoarthritis who need a primary arthroplasty. Participants must be scheduled for anterior total hip replacement, able to follow the study's procedures and attend follow-up visits, and provide informed consent.

Inclusion Criteria

I can follow the study's schedule and visit requirements.

I can understand and agree to the study's procedures and risks.

I have been diagnosed with hip osteoarthritis and need a hip replacement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

Participants receive a standardized multimodal non-opioid analgesic regimen throughout the perioperative period, along with counseling from a Life Care Specialist.

1 week

Daily monitoring during hospital stay

Postoperative Monitoring

Pain scores, nausea, opioid consumption, and patient-reported outcomes are collected during the first postoperative week.

1 week

Daily assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 3 weeks and 3 months.

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Opioid-Sparing Regimen

Trial Overview

The trial tests if an opioid-sparing pain management approach after hip surgery can reduce opioid use while still controlling pain effectively. It compares standard opioid prescriptions with both a placebo and non-opioid analgesia regimen.

How Is the Trial Designed?

Group I: Opioid-Sparing Regimen Experimental Treatment 2 Interventions

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 II: Standard Opioid Prescription Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+