- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05335837
Ilioinguinal/Iliohypogastric Block for Inguinal Hernia Repair
April 14, 2022 updated by: Cheng Lin, Lawson Health Research Institute
Postoperative Recovery Time in Inguinal Hernia Repair Under Ilioinguinal, Iliohypogastric Nerve Block and Sedation Versus General Anesthesia: a Propensity Score Matched-cohort Retrospective Study
Inguinal hernia have traditionally been done under general anesthesia.
While safe, general anesthesia is associated with potential postoperative nausea/vomiting and drowsiness.
Additionally, the recent COVID19 pandemic has heightened the precaution to avoid aerosol generating procedures (AGP) if possible.
General anesthesia requires airway manipulation, thus necessitate performing an AGP.
Recently, we began using peripheral nerve block and sedation as primary anesthetic technique for inguinal hernia repairs.
While surgeon administered local anesthetic, also known as local infiltration, has been done for inguinal hernia repair, using specific nerve blocks and sedation has not been compared with general anesthesia.
We believe the advantage of this novel technique can improve postoperative recovery.
This retrospective study will compare the total hospital length of stay of those receiving nerve blocks and sedation as primary anesthetic techniques versus those with general anesthesia.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
350
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
- Name: Cheng Lin
- Phone Number: 5196858600
- Email: cheng.lin@lhsc.on.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, n6c6a7
- Cheng Lin
-
Contact:
- Cheng Lin
-
-
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
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient
Description
Inclusion Criteria:
- 18 years or older
- American Society of Anesthesiologists (ASA) Physical Status I to III
- Body Mass Index (BMI) less than 45
- Single hernia repair, elective, ambulatory surgery
Exclusion Criteria:
- Opioid dependence (30 mg oral morphine equivalents daily or more)
- History of malignant hyperthermia
- Pregnancy
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
General Anesthesia
patients received general anesthesia for inguinal hernia repair
|
|
|
Regional Anesthesia and Sedation
patients received ilioinguinal/iliohypogastric nerve blocks and sedation for inguinal hernia repair
|
Preoperative ilioinguinal/iliohypogastric nerve block and moderate to deep intraoperative sedation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative recovery time
Time Frame: Time from exiting operating room to time ready for hospital discharge, up to 100 hours
|
Time from exiting operating room to time ready for hospital discharge
|
Time from exiting operating room to time ready for hospital discharge, up to 100 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative time
Time Frame: Time from patient registration to entering operating room, up to 100 hours
|
Time from patient registration to entering operating room
|
Time from patient registration to entering operating room, up to 100 hours
|
|
Intraoperative time
Time Frame: Time from entering to exiting operating room, up to 100 hours
|
Time from entering to exiting operating room
|
Time from entering to exiting operating room, up to 100 hours
|
|
Hospital length of stay
Time Frame: Time from patient registration to ready for hospital discharge, up to 100 hours
|
Time from patient registration to ready for hospital discharge
|
Time from patient registration to ready for hospital discharge, up to 100 hours
|
|
Postoperative nausea vomiting
Time Frame: Time from exiting operating room to time ready for hospital discharge, up to 100 hours
|
Associated symptoms of nausea vomiting, or received non-prophylactic antiemetics
|
Time from exiting operating room to time ready for hospital discharge, up to 100 hours
|
|
Severe pain
Time Frame: Time from exiting operating room to time ready for hospital discharge, up to 100 hours
|
Any incidence when patient rated pain at least 7 out of 10 numeric rating scale
|
Time from exiting operating room to time ready for hospital discharge, up to 100 hours
|
|
Desaturation
Time Frame: Time from exiting operating room to time ready for hospital discharge, up to 100 hours
|
Oxygen saturation below 90% with or without oxygen
|
Time from exiting operating room to time ready for hospital discharge, up to 100 hours
|
|
Postoperative opioid dose
Time Frame: Time from exiting operating room to time ready for hospital discharge, up to 100 hours
|
total postoperative opioid dose in oral morphine equivalents
|
Time from exiting operating room to time ready for hospital discharge, up to 100 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
May 1, 2022
Primary Completion (ANTICIPATED)
June 1, 2022
Study Completion (ANTICIPATED)
July 1, 2022
Study Registration Dates
First Submitted
April 9, 2022
First Submitted That Met QC Criteria
April 14, 2022
First Posted (ACTUAL)
April 19, 2022
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 14, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 119564
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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