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: Recruiting
• 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 (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexander Dawes; Phone Number: 404-784-2402; Email: adawes@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital
      • Contact: Eric Wagner, MD; Email: eric.r.wagner@emory.edu
    • Atlanta, Georgia, United States, 30024
      • Recruiting
      • The Emory Clinic
      • Contact: Eric Wagner, MD; Email: eric.r.wagner@emory.edu
    • Tucker, Georgia, United States, 30084
      • Recruiting
      • Emory Orthopedic and Spine Hospital
      • Contact: Eric Wagner, MD; Email: eric.r.wagner@emory.edu

Participation Criteria

Eligibility Criteria

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

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.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

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, 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient Satisfaction Scores	Patients will be asked their overall level of satisfaction with the procedure and pain control. The investigators will use a rating scale with the following choices: I'm doing MUCH WORSE than I expected; I'm doing SOMEWHAT WORSE than I expected; I'm doing ABOUT THE SAME as I expected; I'm doing SOMEWHAT BETTER than I expected; I'm doing MUCH BETTER than I expected; It is too soon for me to give an opinion The scale has a maximum value of a patient stating they are doing much better than expected (5) and much worse as the minimum value (1) quantifying the worst outcome. Patients stating it is too soon to give an opinion is a null value.	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	The investigators will assess the amount of opioids consumed utilizing total morphine equivalents as an equal metric to compare between patients. It will also de assessed whether the patient utilized he safety/rescue prescription. It will also be included the information on whether patients obtain a refill prescription. Total consumption will be assessed by utilizing total morphine equivalents as the metric as stated previously with patients with higher values quantifying a worse outcome.	Baseline, 60 months post operative
Change in associated side effects	The investigators will utilize a 0-10 scale for patient symptoms for feeling any of these side effects due to postoperative medication for the first 14 days and at each follow up visit. We will assess only at each subsequent follow up visit 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months so long as they are continuously taking medications associated with postoperative pain protocol. Outcomes with a score of 10 will quantify a poor result and patients dealing with severe common side effects due to opioid medication.	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	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. The patient will be asked this question at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months. A rating of 0 is the minimum value and denotes the lowest possible value and worse outcome a patient can have on the scale.	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative
Change in American Shoulder and Elbow Surgeons Index Scale (ASES)	The ASES is a survey designed to assess the condition of the shoulder. This survey will only be utilized in the cases of patients with a shoulder pathology. The survey will utilize the 10 components assessing the activities of daily living. Scores range from 0 to 100 with a score of 0 denoting a worse shoulder condition. The investigators will utilize this assessment at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months.	baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative
Change in European Quality of Life 5 dimension (EQ-5D)	The EQ-5D is one of the most commonly used assessments for measuring health and quality of life. The EQ-5D will be assessed at the following timepoints: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months. The assessment utilizes a scale of 0 to 1 with a score of 0 corresponding to death and 1 representing perfect health.	baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative
Length of stay postoperative	The investigators will assess length of stay as another outcome for surgery types that typically require admission to the hospital. It will be assessed this once and collect data with regards to hospital stay following their discharge from the hospital. A shorter time interval corresponds to a better outcome and those patients with a longer stay is a less desirable outcome.	End of the trial (up to 60 months post operative)
Number of complications	The investigators will assess complications due to surgery such as reoperation, readmission, revision procedure, temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent pain, fractures, and implant loosening and dislocations. The assessment of these complications will happen as they occur and will be recorded as a descriptive and no true values will be recorded rather than the complication itself.	End of the trial (up to 60 months post operative)

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 (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

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): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pain management; Oxycodone
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• 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