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No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair

Primary Purpose

Postoperative Pain, Inguinal Hernia

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Opioids
No opioids
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Center for Abdominal Core HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Minimal Opioids

No opioids

Arm Description

Standard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain

Standard of care

Outcomes

Primary Outcome Measures

Opioid refills/requests
The number of opioid prescription refills/requests will be compared between the two groups

Secondary Outcome Measures

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
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.
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
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

Full Information

First Posted
June 21, 2023
Last Updated
July 17, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05929937
Brief Title
No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair
Official Title
No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Inguinal Hernia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be assigned to receive 5 tablets of Oxycodone (5mg) or none
Masking
None (Open Label)
Allocation
Randomized
Enrollment
904 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minimal Opioids
Arm Type
Other
Arm Description
Standard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain
Arm Title
No opioids
Arm Type
Other
Arm Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
Opioids
Other Intervention Name(s)
Opioid
Intervention Description
Patients will receive a prescription of 5 tablets of opioids (preferred: Oxycodone, or surgeon preference for Oxycodone intolerance)
Intervention Type
Other
Intervention Name(s)
No opioids
Intervention Description
Standard of care, patients will not receive a prescription for opioids.
Primary Outcome Measure Information:
Title
Opioid refills/requests
Description
The number of opioid prescription refills/requests will be compared between the two groups
Time Frame
At the one month follow up visit
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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
Time Frame
At the one month follow up visit
Title
Quality of life, pain, cosmesis
Description
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.
Time Frame
At the one month follow up visit
Title
Patient satisfaction
Description
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
Time Frame
At the one month follow up visit
Title
Number of emergency room (ER)/clinic/urgent care visits for pain
Description
The number of emergency room/clinic/urgent care visits for pain will be compared between the two groups
Time Frame
At the one month follow up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clayton C Petro, MD
Phone
216 445-0053
Email
petroc@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Woo, MD
Phone
216-399-9672
Email
wook2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clayton C Petro, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Center for Abdominal Core Health
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton C Petro, MD
Phone
216-445-0053
Email
petroc@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair

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