Active — Not RecruitingPhase 4

No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair

United States904 participantsStarted 2023-07-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients aged 18 years or older * Patients undergoing elective unilateral or bilateral inguinal hernia repairs * Patients able to tolerate general anesthesia Exclusion Criteria: * Patients who cannot tolerate general anesthesia, * Patients who cannot tolerate opioids or NSAIDS, * Patients on opioids for chronic pain management (defined as near daily use within 90 days), * Patients who undergo surgeries requiring extensive dissection/hernia sac reduction, or additional procedures, * Patients requiring inpatient admission postoperatively * Patients who are not able to understand and sign a written consent form

What they're measuring

Opioid refills/requests

Timeframe: At the one month follow up visit

Trial details

NCT IDNCT05929937

SponsorClayton Petro

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

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