Opioid-Free Orthopaedics

NCT04659317 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: STUDY00000478
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use of opioid medications.

Conditions

Pain; Pain, Postoperative

Keywords

Pain management; Oxycodone

Outcome Measures

Primary Outcomes (1)

• Change in Pain (VAS) Score

  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.

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

Secondary Outcomes (8)

• Change in patient Satisfaction Scores

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

• Change in opioid consumption

  Baseline, 60 months post operative

• Change in associated side effects

  Postoperatively for the first 14 days, and then 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative

• Change in Single Assessment Numeric Evaluation (SANE) score

  Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative

• Change in American Shoulder and Elbow Surgeons Index Scale (ASES)

  baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative

Study Arms (2)

Opioid Group

ACTIVE COMPARATOR

Participants will receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain

Drug: Oxycodone 5 mg Oral Tablet

Placebo Group

EXPERIMENTAL

Participants will receive encapsulated placebo tablets x24, to take po q6 hours as need for pain after surgery "Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain

Drug: Placebo oral tablet

Interventions

Oxycodone 5 mg Oral Tablet DRUG

Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed

Opioid Group

Placebo oral tablet DRUG

Encapsulated placebo tablets x24, to take po q6 hours as need for pain

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

The Emory Clinic

Atlanta, Georgia, 30024, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Orthopedic and Spine Hospital

Tucker, Georgia, 30084, United States

RECRUITING

MeSH Terms

Conditions

Pain; Pain, Postoperative; Agnosia

Interventions

Oxycodone; Tablets

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Eric Wagner, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Dawes

CONTACT

404-784-2402; adawes@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 9, 2020
• Study Start: December 11, 2020
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)