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No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair

NCT05929937 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 904

Last updated 2026-03-06

No results posted yet for this study

Summary

The investigators hypothesize that not prescribing opioids after uncomplicated, outpatient IHR will be non-inferior to prescribing opioids (5 tablets of Oxycodone, 5mg; or surgeon preference for intolerance) with respect to requests for opioid refills. Additionally, the investigators believe there will be no significant difference in postoperative readmission for pain quality of life at 30 days in either group.

Conditions

  • Postoperative Pain
  • Inguinal Hernia

Interventions

DRUG

Opioids

Patients will receive a prescription of 5 tablets of opioids (preferred: Oxycodone, or surgeon preference for Oxycodone intolerance)

OTHER

No opioids

Standard of care, patients will not receive a prescription for opioids.

Sponsors & Collaborators

  • Clayton Petro

    lead OTHER

Principal Investigators

  • Clayton C Petro, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2027-06-30
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05929937 on ClinicalTrials.gov