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Opioid-Free Approach for Postoperative Pain

Phase 3
Recruiting
Led By Eric Wagner, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow
Patients with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative
Awards & highlights

Study Summary

This trial is testing a new pain control regimen that doesn't use opioids to see if it is as effective as the current standard of care.

Who is the study for?
This trial is for adults over 18 with advanced arthritis needing joint replacement or orthopaedic surgery on limbs, who have tried nonoperative treatments. Excluded are pregnant women, minors, those unwilling to consent, patients with recent opioid use, significant other injuries or conditions like uncontrolled diabetes or liver/renal disease.Check my eligibility
What is being tested?
The study compares the effectiveness of a multimodal pain control regimen with and without opioids in managing post-surgery pain. Participants will receive either Oxycodone tablets or placebo pills after their orthopaedic procedures.See study design
What are the potential side effects?
While not specified here, common side effects of Oxycodone can include nausea, constipation, drowsiness and risk of dependency. Placebos typically have no active ingredients but can cause perceived side effects due to patient expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having surgery on my finger, hand, wrist, forearm, or elbow.
Select...
I am having a joint replacement due to severe arthritis.
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I've tried non-surgical treatments like rest, injections, and physical therapy for over 3 months.
Select...
I am over 18 and can make my own medical decisions.
Select...
I am having surgery on my hip, knee, ankle, or foot.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pain (VAS) Score
Secondary outcome measures
Change in American Shoulder and Elbow Surgeons Index Scale (ASES)
Change in European Quality of Life 5 dimension (EQ-5D)
Change in Single Assessment Numeric Evaluation (SANE) score
+5 more

Side effects data

From 2021 Phase 3 trial • 440 Patients • NCT04029116
19%
Headache
8%
Diarrhoea
8%
Bacterial vaginosis
5%
Nausea
5%
Abdominal pain upper
5%
COVID-19
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrexafungerp
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Placebo GroupExperimental Treatment1 Intervention
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 II: Opioid GroupActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo oral tablet
2019
Completed Phase 4
~2450

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,632 Previous Clinical Trials
2,556,397 Total Patients Enrolled
10 Trials studying Pain
1,545 Patients Enrolled for Pain
Eric Wagner, MDPrincipal Investigator - Emory University
Emory University Hospital, Emory University Hospital Midtown
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Opioid-Free Orthopaedics (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04659317 — Phase 3
Pain Research Study Groups: Opioid Group, Placebo Group
Pain Clinical Trial 2023: Opioid-Free Orthopaedics Highlights & Side Effects. Trial Name: NCT04659317 — Phase 3
Opioid-Free Orthopaedics (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04659317 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~47 spots leftby Dec 2028