No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Pain; Inguinal Hernia
• Intervention / Treatment: Drug: Opioids; Other: No opioids

Detailed Description

Patients presenting with primary or recurrent inguinal hernias, previously repaired in an open fashion, will be considered eligible to be enrolled in this study. Exclusion criteria include patients who cannot tolerate general anesthesia, opioids or NSAIDS, surgeries requiring extensive dissection/hernia sac reduction, or additional procedures, patients requiring inpatient admission postoperatively, and patients who are not able to understand and sign a written consent form. Surgeons will notify a study coordinator at the end of surgery for randomization. Patients will be randomized to opioids versus no opioids at the end of surgery and stratified based on unilateral versus bilateral inguinal hernia repair. The intervention will be not prescribing opioids post-operatively. If patients require prescription for opioids after randomization for uncontrolled pain for the no opioid group, the patient will remain in the intervention group and will be treat as intention to treat which will be recorded in REDCap®. All patients in the study will receive prescriptions for Acetaminophen and Ibuprofen. No other intraoperative or postoperative differences will occur between the two groups.

Baseline information, operative details, and 30-day outcomes are already captured within the ACHQC database, allowing for follow-up, and data capture with decreased effort outside of routine care. Randomization data will be captured and stored in REDCap®.

Baseline patient demographics will be obtained at initial patient recruitment, and baseline ACHQC questionnaires will be completed following patient recruitment. All operative details are already routinely collected and stored in the ACHQC database. Patient-reported quality of life will also be assessed at baseline and at 30 days using the EuraHS Quality Of Life survey tool, which is collected for all patients entered into the ACHQC as part of the ACHQC Inguinal Hernia Postoperative Assessment. Patients will be required to complete these forms at each clinic visit, or via telephone contact, as this is standard procedure for all patients entered into the ACHQC. At the time of the one-month follow-up clinic visits, a routine physical examination will be performed on all patients.

Outcomes to be investigated:

• Specific Aim #1: To determine if the use of post-operative use of opioids results in a difference in rate of opioid refills/requests when compared to those not initially prescribed opioids.
• Specific Aim #2: To determine if the use of post-operative use of opioids results in a difference in Patient-Reported Outcome Measurement Information System (PROMIS Pain Intensity) scores at the 1 month follow up visit post-operatively when compared to those not prescribed opioids.
• Specific Aim #3: To determine if the use of post-operative use of opioids results in a difference in EuraHS (European registry for abdominal wall hernias) Quality of Life (QoL) scores at the 1 month follow up visit post-operatively when compared to those not prescribed opioids.
• Specific Aim #4: To determine if the use of post-operative use of opioids results in a difference in all 30-day complications when compared to those not prescribed opioids.

• Study Type: Interventional
• Enrollment (Estimated): 904
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • North York General Hospital
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • MemorialCare
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Corewell Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Center for Abdominal Core Health
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Prisma Health
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Minimal Opioids; Standard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain	Drug: Opioids; Patients will receive a prescription of 5 tablets of opioids (preferred: Oxycodone, or surgeon preference for Oxycodone intolerance); Other Names: Opioid
Other: No opioids; Standard of care	Other: No opioids; Standard of care, patients will not receive a prescription for opioids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postop pain will be assessed using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a scale scale between the two groups where higher scores mean worse pain	At the one month follow up visit
Quality of life, pain, cosmesis	Quality of life, pain, and cosmetic outcomes will be assessed using the EuraHS (European registry for abdominal wall hernias) Quality of Life scale between the two groups where higher scores mean worse quality of life.	At the one month follow up visit
Patient satisfaction	Overall patient satisfaction: patients will be asked if they are dissatisfied, neutral, or satisfied with respect to their postoperative pain management and the responses will be compared between the two groups	At the one month follow up visit
Number of emergency room (ER)/clinic/urgent care visits for pain	The number of emergency room/clinic/urgent care visits for pain will be compared between the two groups	At the one month follow up visit

Collaborators and Investigators

• Sponsor: Clayton Petro
• Investigators: Principal Investigator: Clayton C Petro, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 1, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Hernia, Inguinal; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Central Nervous System Agents; Analgesics, Opioid
• Other Study ID Numbers: 23-189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No