Clinical trial NCT05929937: No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair
Official title: No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Postoperative Pain
Inguinal Hernia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 904
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned to receive 5 tablets of Oxycodone (5mg) or none
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid refills/requests
timeFrame: At the one month follow up visit
Secondary outcomes:
measure: Postoperative pain
timeFrame: At the one month follow up visit
measure: Quality of life, pain, cosmesis
timeFrame: At the one month follow up visit
measure: Patient satisfaction
timeFrame: At the one month follow up visit
measure: Number of emergency room (ER)/clinic/urgent care visits for pain
timeFrame: At the one month follow up visit
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: MemorialCare
state: California
city: Royal Oak
country: United States
facility: Corewell Health
state: Michigan
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Center for Abdominal Core Health
state: Ohio
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: Clayton C Petro, MD
role: PRINCIPAL_INVESTIGATOR
References: