Opioid-Free Orthopaedics

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Pain, Postoperative
• Intervention / Treatment: Drug: Oxycodone 5 mg Oral Tablet; Drug: Placebo oral tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30029
      • The Emory Clinic
    • Tucker, Georgia, United States, 30084
      • Emory Orthopedic and Spine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Oxycodone 5 mg Oral Tablet; Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed
Experimental: 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	Drug: Placebo oral tablet; Encapsulated placebo tablets x24, to take po q6 hours as need for pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 and 24 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, then 3 months, 6 months, 12 months, and 24 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Opioid Consumption	Total opioid consumption in Morphine milligram equivalents (MME) during the first 2 weeks after surgery will be measured.	Postoperative Days 1-14
Number of participants that required Rescue Opioid Prescription	Number of participants that required the prescribed rescue ("safety") opioid prescription during the first 2 postoperative weeks.	Postoperative Days 1-14
Number of tables consumed as Rescue Opioid	Number of tablets taken from the prescribed rescue ("safety") opioid prescription during the first 2 postoperative weeks.	Postoperative Days 1-14
Number of Additional Opioid Prescription Refills	Number of additional opioid prescription refills required during the postoperative period.	Postoperative Days 1-14
Number of participants experiencing Postoperative Nausea	Number of participants experiencing nausea during the postoperative period. This scale will assess nausea at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The scale will range from 0-10 with 10 being a worse outcome quantifying the highest nausea rating.	Three times a day postoperatively for the first 2 weeks
Hand/Wrist function Measured by the Single Assessment Numeric Evaluation (SANE)	The Single Assessment Numeric Evaluation (SANE) score requires the patient to rate their injured extremity 0-100 as a percentage of their function compared to normal. A rating of 0 is the minimum value and denotes the worse outcome a patient can have on the scale.	Baseline (Preoperative); and at 3, 6, 12, and 24 months postoperatively.
Upper Extremity Function Measured by the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)	Upper extremity disability will be assessed using the QuickDASH questionnaire. Scores range from 0 to 100, with lower scores indicating less disability.	Baseline (Preoperative); and at 12 and 24 months postoperatively.
Overall Satisfaction with the procedure and Pain Management	Overall satisfaction with the surgical procedure and postoperative pain management will be assessed using a patient-reported 5-point rating scale. Participants will select one of the following responses: "Very satisfied", "satisfied", "neutral", "dissatisfied", and "Very dissatisfied". Responses are assigned a score from 1 to 5, where 1 corresponds to "very dissatisfied" and 5 corresponds to "very satisfied". Higher scores indicate greater satisfaction and better perceived outcomes	12 and 24 months postoperatively
Willingness to undergo the same procedure with the same pain management	Number of Participants that confirm their willingness to undergo the same procedure again using the same postoperative pain management regimen.	12 and 24 months postoperatively
Number of participants Experiencing Major Postoperative Complications	Number of participants experiencing one or more major postoperative complications, including temporary or permanent nerve injury, hematoma, superficial or deep infection, recurrent moderate or severe pain, fracture, implant loosening, dislocation, or revision surgery.	From surgery through 24 months postoperatively

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Eric Wagner, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): July 20, 2026
• Study Completion (Actual): July 20, 2026

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 10, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Pain management; Oxycodone
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pain, Postoperative; Agnosia; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Dosage Forms; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Codeine; Oxycodone; Tablets
• Other Study ID Numbers: STUDY00000478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No