NCT05335837

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

April 9, 2022

Last Update Submit

April 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative recovery time

    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 Outcomes (7)

  • Preoperative time

    Time from patient registration to entering operating room, up to 100 hours

  • Intraoperative time

    Time from entering to exiting operating room, up to 100 hours

  • Hospital length of stay

    Time from patient registration to ready for hospital discharge, up to 100 hours

  • Postoperative nausea vomiting

    Time from exiting operating room to time ready for hospital discharge, up to 100 hours

  • Severe pain

    Time from exiting operating room to time ready for hospital discharge, up to 100 hours

  • +2 more secondary outcomes

Study Arms (2)

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

Procedure: Regional Anesthesia and Sedation

Interventions

Preoperative ilioinguinal/iliohypogastric nerve block and moderate to deep intraoperative sedation.

Regional Anesthesia and Sedation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient

You may qualify if:

  • 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

You may not qualify if:

  • Opioid dependence (30 mg oral morphine equivalents daily or more)
  • History of malignant hyperthermia
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheng Lin

London, Ontario, n6c6a7, Canada

Location

MeSH Terms

Interventions

Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 9, 2022

First Posted

April 19, 2022

Study Start

May 1, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations