Opioid-Free Orthopaedics Study

This study is looking at ways to manage pain after orthopedic surgery without relying on opioid medications. Researchers want to compare a new pain management plan with and without Oxycodone 5 mg Oral Tablet. You might be able to join if you are an adult undergoing certain joint replacement or other orthopedic procedures for your finger, hand, wrist, forearm, elbow, hip, knee, ankle, or foot. The main goal is to see how much your pain changes over time, measured up to 60 months after surgery. The study status is currently unclear, and it plans to enroll 80 participants.

Study design: This is a prospective, double-blinded, randomized controlled trial involving 80 participants. Participants will receive either encapsulated Oxycodone 5 mg Oral Tablet or a placebo.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Your pain levels will be measured three times a day postoperatively for the first 2 weeks, then at 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Opioid-Free Orthopaedics

Recruiting

PHASE3Ages 18+InterventionalTreatment

Emory University

~80 participants

Updated 2026-04-30 on ClinicalTrials.gov

What's tested:Oxycodone 5 mg Oral TabletPlacebo oral tablet

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in Pain (VAS) Score

Measured over Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative

Conditions

Pain

Pain, Postoperative

Where it's being run

3 sites across 1 states

Georgia3

Study leadership

Eric Wagner, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Alexander Dawes

[email protected]

404-784-2402

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting.

Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow

Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot

Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy.

Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent

Exclusion

Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C \>9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications.i. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study.

Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

What this trial measures

Change in Pain (VAS) ScoreThree times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
The investigators will assess patient postoperative pain utilizing a visual analog scale (VAS) for the first 14 days postoperatively. They will also assess pain at each postoperative visit after at 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months. This scale will assess pain at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The pain scale will range from 0-10 with 10 being a worse outcome quantifying the highest pain rating.

Trialytics