Opioid-Free Orthopaedics

NCT ID: NCT04659317

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-11
• Study Completion Date: 2028-12-31

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.

Detailed Description

Prolonged opioid usage after orthopaedic surgery is an important consideration for both the opioid epidemic and postoperative outcomes. The investigators have developed a multimodal pain control regimen designed to decrease or even potentially eliminate the need for opioids after an orthopedic procedure. This is a prospective double blinded randomized controlled trial utilizing a multimodal pain regimen consisting of education and our standard multimodal pain control regimen. Then, the plan is to randomize patients to receive either encapsulated opioids or placebo. The team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. This study will serve as a foundation for future opioid-free surgeries and investigations, while helping to identify patients and factors at risk for prolonged opioid usage postoperatively.

Conditions

Pain; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Opioid Group

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

Group Type: ACTIVE_COMPARATOR

Oxycodone 5 mg Oral Tablet

Intervention Type: DRUG

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

Placebo Group

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

Group Type: EXPERIMENTAL

Placebo oral tablet

Intervention Type: DRUG

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

Interventions

Oxycodone 5 mg Oral Tablet

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

Intervention Type: DRUG

Placebo oral tablet

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Eric Wagner

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Wagner, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

The Emory Clinic

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Orthopedic and Spine Hospital

Tucker, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexander Dawes

Role: CONTACT

adawes@emory.edu

404-784-2402

Facility Contacts

Eric Wagner, MD

Role: primary

eric.r.wagner@emory.edu

Eric Wagner, MD

Role: primary

eric.r.wagner@emory.edu

Eric Wagner, MD

Role: primary

eric.r.wagner@emory.edu

Other Identifiers

STUDY00000478

Identifier Type: -

Identifier Source: org_study_id