No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair

March 4, 2026 updated by: Clayton Petro
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
904

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Clayton C Petro, MD
  • Phone Number: 216 445-0053
  • Email: petroc@ccf.org

Study Contact Backup

  • Name: Noah Tocci, MD
  • Phone Number: 216-3416-1447
  • Email: toccin@ccf.org

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid refills/requests
Time Frame: At the one month follow up visit
The number of opioid prescription refills/requests will be compared between the two groups
At the one month follow up visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: At the one month follow up visit
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
Time Frame: At the one month follow up visit
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
Time Frame: At the one month follow up visit
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
Time Frame: At the one month follow up visit
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clayton Petro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clayton C Petro, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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