RECRUITING

Opioid-Free Orthopaedics

Conditions

Pain Pain, Postoperative Pain management Oxycodone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-11

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04659317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Alexander Dawes

CONTACT

404-784-2402

adawes@emory.edu

Principal Investigator

Eric Wagner, MD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

The Emory Clinic

Atlanta, Georgia, 30024

United States

Emory University Hospital

Atlanta, Georgia, 30322

United States

Emory Orthopedic and Spine Hospital

Tucker, Georgia, 30084

United States

Collaborators and Investigators

Sponsor: Emory University

Eric Wagner, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-11

Study Completion Date2028-12

Study Record Updates

Study Start Date2020-12-11

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

Pain management
Oxycodone

Additional Relevant MeSH Terms

Pain
Pain, Postoperative