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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative

Awards & highlights

Pivotal Trial

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain (VAS) Score

Secondary study objectives

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

Diarrhoea

Bacterial vaginosis

Nausea

Abdominal pain upper

COVID-19

Influenza

100%

80%

60%

40%

20%

Study treatment Arm

Ibrexafungerp

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~2430

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