AnesthesiaNCT05335837
Ilioinguinal/Iliohypogastric Block for Inguinal Hernia Repair
An observational study of Anesthesia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Regional Anesthesia and Sedation
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2022to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient
Who may be able to join
- 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
Who cannot join
- Opioid dependence (30 mg oral morphine equivalents daily or more)
- History of malignant hyperthermia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anesthesia
- Being tested
- Regional Anesthesia and Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional Anesthesia and SedationProcedure or surgery
Preoperative ilioinguinal/iliohypogastric nerve block and moderate to deep intraoperative sedation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Regional Anesthesia and Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative recovery time
Time from exiting operating room to time ready for hospital discharge
Measured: 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
Measured: Time from patient registration to entering operating room, up to 100 hours
Intraoperative time
Time from entering to exiting operating room
Measured: Time from entering to exiting operating room, up to 100 hours
Hospital length of stay
Time from patient registration to ready for hospital discharge
Measured: Time from patient registration to ready for hospital discharge, up to 100 hours
Postoperative nausea vomiting
Associated symptoms of nausea vomiting, or received non-prophylactic antiemetics
Measured: Time from exiting operating room to time ready for hospital discharge, up to 100 hours
Severe pain
Any incidence when patient rated pain at least 7 out of 10 numeric rating scale
Measured: Time from exiting operating room to time ready for hospital discharge, up to 100 hours
Desaturation
Oxygen saturation below 90% with or without oxygen
Measured: Time from exiting operating room to time ready for hospital discharge, up to 100 hours
Postoperative opioid dose
total postoperative opioid dose in oral morphine equivalents
Measured: Time from exiting operating room to time ready for hospital discharge, up to 100 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Lin, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335837
- Sponsor's protocol ID
- 119564
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Recovery Time in Inguinal Hernia Repair Under Ilioinguinal, Iliohypogastric Nerve Block and Sedation Versus General Anesthesia: a Propensity Score Matched-cohort Retrospective Study
- ClinicalTrials.gov ID
- NCT05335837
- Acronym / sponsor ID
- 119564
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | –patients received general anesthesia for inguinal hernia repair |
| Regional Anesthesia and Sedation | – | Procedure: Regional Anesthesia and Sedationpatients received ilioinguinal/iliohypogastric nerve blocks and sedation for inguinal hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Opioid dependence (30 mg oral morphine equivalents daily or more)
- History of malignant hyperthermia
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional Anesthesia and SedationPreoperative ilioinguinal/iliohypogastric nerve block and moderate to deep intraoperative sedation. | Procedure or surgery | Regional Anesthesia and Sedation |
Primary outcome
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
7 secondary outcomes
Preoperative time
Time frame: 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
Hospital length of stay
Time frame: 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
Severe pain
Time frame: 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
Postoperative opioid dose
Time frame: Time from exiting operating room to time ready for hospital discharge, up to 100 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Lin (5196858600, cheng.lin@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative recovery time (time frame: Time from exiting operating room to time ready for hospital discharge, up to 100 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.