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

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

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.

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

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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