RecruitingPhase 3NCT04659317

Opioid-Free Orthopaedics

A Double-Blinded Randomized Controlled Trial Examining Multimodal Opioid-Free Orthopaedic Procedures

Sponsor

Emory University

Enrollment

80 participants

Start Date

Dec 11, 2020

Study Type

INTERVENTIONAL

Conditions

Pain Pain, Postoperative

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria3

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

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