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No vs. Minimal Opioids After Inguinal Hernia Repair

Phase 3
Recruiting
Led By Clayton C Petro, MD
Research Sponsored by Clayton Petro
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 at the one month follow up visit
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare not prescribing opioids to prescribing 5 tablets of Oxycodone to see if there's a difference in pain relief & readmissions.

Who is the study for?
This trial is for adults over 18 who are having elective inguinal hernia repairs and can handle general anesthesia. It's not suitable for those with conditions that might complicate surgery or recovery.
What is being tested?
The study is testing if avoiding opioids after hernia surgery is just as good as giving a small amount (5 tablets of Oxycodone, or another drug if there's an intolerance). They're looking at the need for more pain meds and quality of life after a month.
What are the potential side effects?
Opioids may cause drowsiness, constipation, nausea, addiction risk, and other side effects. Not using opioids avoids these risks but may result in different pain management challenges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the one month follow up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the one month follow up visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Opioid refills/requests
Secondary study objectives
Number of emergency room (ER)/clinic/urgent care visits for pain
Patient satisfaction
Postoperative pain
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: No opioidsExperimental Treatment1 Intervention
Standard of care
Group II: Minimal OpioidsExperimental Treatment1 Intervention
Standard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Opioids
2018
Completed Phase 4
~1950

Find a Location

Who is running the clinical trial?

Clayton PetroLead Sponsor
4 Previous Clinical Trials
728 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,053 Previous Clinical Trials
1,370,270 Total Patients Enrolled
Clayton C Petro, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
286 Total Patients Enrolled

Media Library

Minimal opioids (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05929937 — Phase 3
Inguinal Hernia Research Study Groups: Minimal Opioids, No opioids
Inguinal Hernia Clinical Trial 2023: Minimal opioids Highlights & Side Effects. Trial Name: NCT05929937 — Phase 3
Minimal opioids (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05929937 — Phase 3
Inguinal Hernia Patient Testimony for trial: Trial Name: NCT05929937 — Phase 3
~590 spots leftby Jun 2027
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