Postoperative PainPhase 4NCT05929937
No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair
A Phase 4 study testing Opioids and No opioids in people with Postoperative Pain and Inguinal Hernia, run by Clayton Petro at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Inguinal Hernia
- What is being tested?
- Opioids and No opioids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 904 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 10 Jul 2023to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older
- Patients undergoing elective unilateral or bilateral inguinal hernia repairs
- Patients able to tolerate general anesthesia
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
University Hospitals
Cleveland, Ohio, 44106
Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, 44195
MemorialCare
Fountain Valley, California, 92708
Prisma Health
Greenville, South Carolina, 29607
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Corewell Health
Royal Oak, Michigan, 48073
About this study
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.
Read the 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.
- Conditions
- Postoperative Pain, Inguinal Hernia
- Being tested
- Opioids, No opioids
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpioidsDrug
Also called Opioid
Patients will receive a prescription of 5 tablets of opioids (preferred: Oxycodone, or surgeon preference for Oxycodone intolerance)
No opioidsOther
Standard of care, patients will not receive a prescription for opioids.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Opioids | Other | Standard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain Receives: Drug: Opioids |
| No opioids | Other | Standard of care Receives: Other: No opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid refills/requests
The number of opioid prescription refills/requests will be compared between the two groups
Measured: At the one month follow up visit
Secondary outcomes (4)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: At the one month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start10 Jul 2023
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to receive 5 tablets of Oxycodone (5mg) or none
- Masking
- None (open label)
- Enrolment
- 904 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clayton Petro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clayton Petro, The Cleveland Clinic
- Investigators
- Clayton C Petro, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929937
- Sponsor's protocol ID
- 23-189
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT05929937
- Acronym / sponsor ID
- 23-189
- Conditions
- Postoperative Pain, Inguinal Hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 904 participants (estimated)
- Lead sponsor
- Clayton PetroUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned to receive 5 tablets of Oxycodone (5mg) or none
| Arm | Type | Receives |
|---|---|---|
| Minimal Opioids | Other | Drug: OpioidsStandard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain |
| No opioids | Other | Other: No opioidsStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 years or older
- Patients undergoing elective unilateral or bilateral inguinal hernia repairs
- Patients able to tolerate general anesthesia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OpioidsAlso: OpioidPatients will receive a prescription of 5 tablets of opioids (preferred: Oxycodone, or surgeon preference for Oxycodone intolerance) | Drug | Minimal Opioids |
| No opioidsStandard of care, patients will not receive a prescription for opioids. | Other | No opioids |
Primary outcome
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
4 secondary outcomes
Postoperative pain
Time frame: At the one month follow up visit
Quality of life, pain, cosmesis
Time frame: At the one month follow up visit
Patient satisfaction
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clayton C Petro, MD principal investigator
The Cleveland Clinic
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Opioids and No opioids in people with Postoperative Pain and Inguinal Hernia, run by Clayton Petro at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid refills/requests (time frame: At the one month follow up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.