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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

Study 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.Check my eligibility
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.See study design
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

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

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
1,030 Previous Clinical Trials
1,364,654 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks can Opioids pose to individuals?

"This medication has been evaluated on multiple occasions, so its safety was rated a 3. Additionally, there is evidence that opioids are effective for their intended use in this Phase 3 trial."

Answered by AI

Are there any spot still available to join this experiment?

"Affirmative. The clinical trial is actively enlisting patients, as per the information available on clinicaltrials.gov. This investigation was first posted on July 1st 2023 and has been modified since then; it seeks to recruit 904 individuals from a single location."

Answered by AI

How many participants have enrolled in the trial thus far?

"Indeed, the data hosted on clinicaltrials.gov implies that this research is still actively recruiting participants. This trial was published on July 1st 2023 and has since been edited once on the same date. They are looking for a total of 904 volunteers from one hospital site."

Answered by AI

Who else is applying?

What site did they apply to?
Cleveland Clinic Center for Abdominal Core Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What state do they live in?
Utah

Why did patients apply to this trial?

need surgery and can't afford to pay for it.
PatientReceived no prior treatments
~603 spots leftby Jun 2027