Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05929937 |
| Other study ID # |
23-189 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
July 10, 2023 |
| Est. completion date |
July 2027 |
Study information
| Verified date |
June 2024 |
| Source |
The Cleveland Clinic |
| Contact |
Clayton C Petro, MD |
| Phone |
216 445-0053 |
| Email |
petroc[@]ccf.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. Additionally, the
investigators believe there will be no significant difference in postoperative readmission
for pain quality of life at 30 days in either group.
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.
