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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05335837
Other study ID # 119564
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date July 1, 2022

Study information

Verified date April 2022
Source Lawson Health Research Institute
Contact Cheng Lin
Phone 5196858600
Email cheng.lin@lhsc.on.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 350
Est. completion date July 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Regional Anesthesia and Sedation
Preoperative ilioinguinal/iliohypogastric nerve block and moderate to deep intraoperative sedation.

Locations

Country Name City State
Canada Cheng Lin London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Preoperative time Time from patient registration to entering operating room Time from patient registration to entering operating room, up to 100 hours
Secondary Intraoperative time Time from entering to exiting operating room Time from entering to exiting operating room, up to 100 hours
Secondary Hospital length of stay Time from patient registration to ready for hospital discharge Time from patient registration to ready for hospital discharge, up to 100 hours
Secondary Postoperative nausea vomiting 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
Secondary Severe pain 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
Secondary Desaturation Oxygen saturation below 90% with or without oxygen Time from exiting operating room to time ready for hospital discharge, up to 100 hours
Secondary Postoperative opioid dose total postoperative opioid dose in oral morphine equivalents Time from exiting operating room to time ready for hospital discharge, up to 100 hours
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