No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair

NCT05929937 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 23-189
• Study Type: interventional
• Target: 904
• Locations: 2 countries
• Sites: 8

Brief 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

Outcome Measures

Primary Outcomes (1)

• Opioid refills/requests

  The number of opioid prescription refills/requests will be compared between the two groups

  At the one month follow up visit

Secondary Outcomes (4)

• Postoperative pain

  At the one month follow up visit

• Quality of life, pain, cosmesis

  At the one month follow up visit

• Patient satisfaction

  At the one month follow up visit

• Number of emergency room (ER)/clinic/urgent care visits for pain

  At the one month follow up visit

Study Arms (2)

Minimal Opioids

OTHER

Standard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain

Drug: Opioids

No opioids

OTHER

Standard of care

Other: No opioids

Interventions

Opioids DRUG

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

Also known as: Opioid

Minimal Opioids

No opioids OTHER

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

No opioids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years or older
• Patients undergoing elective unilateral or bilateral inguinal hernia repairs
• Patients able to tolerate general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Clayton Petro: lead

Study Sites (8)

MemorialCare

Fountain Valley, California, 92708, United States

Location

Corewell Health

Royal Oak, Michigan, 48073, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Center for Abdominal Core Health

Cleveland, Ohio, 44195, United States

Location

Prisma Health

Greenville, South Carolina, 29607, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

North York General Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Clayton C Petro, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Surgery Lerner College of Medicine

Model Details: Patients will be assigned to receive 5 tablets of Oxycodone (5mg) or none

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 3, 2023
• Study Start: July 10, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CA (1)