AnesthesiaNCT05968261
Near Remote Method to Guide Performance of Regional Anesthesia
An observational study of Anesthesia and Analgesia, run by Dr. Glenio Mizubuti (MD, PhD) at 1 site in Canada.
Trial summary
Ultrasound-guided regional anesthesia/analgesia techniques (or simply, 'regional blocks') have gained popularity as they can reduce, and sometimes even eliminate, the need for opiate analgesics (and, consequently, their side effects), thereby improving patient safety, reducing length of hospital stay and medical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Analgesia, Nerve Block
- What is being tested?
- Real time 'near remote' guidance of regional blocks
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2026to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will include: (1) mentors, i.e., staff regional anesthesiologists who are experts in ultrasound-guided regional blocks; (2) trainees, i.e., PGY-3 to PGY-5 anesthesia and emergency medicine residents, and emergency medicine staff physicians; and (3) patients, i.e., individuals 18 years and older scheduled for surgery amenable to regional blocks or presenting to the emergency department with traumatic injuries amenable to regional blocks.
Who may be able to join
- Mentors: Staff anesthesiologists who are experts in regional blocks.
- Trainees: Senior (PGY3-5) residents (anesthesiology and emergency medicine), and staff (emergency medicine) physicians who have already performed and are comfortable with being supervised near remotely for the regional block at hand.
- Patients: Greater or equal to 18 years of age presenting for surgery or with traumatic injuries amenable to regional blocks.
- All of the above: Able to read and understand English, and competent to provide written informed consent.
Who cannot join
- Mentors: Staff anesthesiologists who are not experts in the performance/teaching of regional blocks.
- Trainees: Junior (PGY1-2) residents (for any/all types of regional blocks), and senior (PGY3-5) residents and staff physicians who are not comfortable with being supervised near remotely for the regional block at hand.
- Patients: Less than 18 years of age.
- All of the above: Unable to read and understand English, and not competent to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hotel Dieu Hospital site (primary) and Kingston General Hospital site (secondary), Kingston Health Sciences Centre
Kingston, Ontario, K7L 5G2
Stephanie Chevrier, MD, (613) 548-7827, stephanie.chevrier@kingstonhsc.ca
Glenio B. Mizubuti, MD, MSc, FRCPC, (613) 548-7827, glenio.mizubuti@kingstonhsc.ca
About this study
Official title: Implementation and Measurement of a Real-time, Near-remote Method to Operationalize Ultrasound-based Regional Anesthesia/Analgesia Procedural Techniques
Ultrasound-guided regional anesthesia/analgesia techniques (or simply, 'regional blocks') have gained popularity as they can reduce, and sometimes even eliminate, the need for opiate analgesics (and, consequently, their side effects), thereby improving patient safety, reducing length of hospital stay and medical costs, and improving patient satisfaction. However, a major barrier to mainstream uptake of such techniques relates to training. These techniques require the acquisition of new skills under expert guidance, which is often not possible given the daily demands placed upon anesthesiologists. As a result, many opportunities for providing regional blocks may be missed.
The purpose of this study is to implement a new real-time 'near remote' guidance method in which trainees who are to perform regional blocks can do so via tele-mentoring under expert guidance. This will be done using a novel technology whereby the ultrasound image is concurrently displayed on an iPad screen (for the block operator/trainee) as well as on the (near remotely supervising) expert mentor's smartphone. Trainees and mentors will use this method to perform various standard of care regional blocks, either in the perioperative or emergency department settings. Participants' opinions of the novel teaching and learning method will be assessed.
Read the detailed description
Ultrasound-guided regional anesthesia/analgesia techniques (herein referred to simply as 'regional blocks') have gained popularity as they can reduce, and sometimes even eliminate, the need for opiate analgesics (and, consequently, their side effects), thereby improving patient safety, reducing length of hospital stay and medical costs, and improving patient satisfaction. However, a major barrier to mainstream uptake of such techniques relates to training. These techniques require the acquisition of new skills under expert guidance, which is often not possible given the daily time-sensitive and competing demands placed upon anesthesiologists. Furthermore, staff shortages and increasing demands caused by the COVID-19 pandemic have limited expert availability for one-on-one guidance even more. As a result, many opportunities for providing regional analgesia may be missed or performed in the absence of expert guidance.
Currently, expert staff regional anesthesiologists would ideally be available to supervise regional blocks. In clinical practice, however, if no staff regional anesthesiologist is available to supervise, senior anesthesia residents (post-graduate years 3 to 5) will often proceed with performing lower-risk blocks (e.g., adductor canal blocks) independently provided they feel confident and comfortable with the technique. If, however, the senior anesthesia resident is not comfortable with performing a higher-risk block without supervision, the patient would likely then receive general anesthesia combined with a multimodal analgesic regimen for perioperative pain control.
The purpose of the current study is to implement a new real-time 'near-remote' guidance method, in which trainees who are to perform regional blocks can do so via tele-mentoring under expert guidance. This will be done using an ultrasound-linked iPad which is a novel technology whereby the high-resolution ultrasound image is concurrently displayed on an iPad screen (for the block operator/trainee) as well as on the (near remotely supervising) expert mentor's smartphone. The expert mentor will either be at a distance in the same room or in an adjacent room, but readily available to intervene quickly if necessary. Trainees and mentors will use this method to perform various standard of care regional blocks on patients, either prior to elective surgical procedures or in the emergency department in the context of trauma injuries. All regional blocks will be as per standard of care, except they will be performed under expert 'near-remote' guidance.
Following the regional block performed via tele-mentored expert-guidance, both the trainee and mentor will complete a questionnaire pertaining to that particular block. Questionnaires will be completed electronically via Qualtrics. Block success will also be assessed (i.e., sensory block to ice within 30 min following block performance, as per standard of care) and documented. Towards the end of the study, voluntary focus group sessions will be held, during which trainees and mentors will have the opportunity to provide feedback regarding the newly implemented teaching and learning method. Thematic analyses will then be conducted.
Success with the current study may lay the groundwork for future research investigations to examine the feasibility of guiding such blocks by more remote methods (i.e., with the expert more than a few feet away).
- Conditions
- Anesthesia, Analgesia, Nerve Block, Delivery of Healthcare, Hospitals, Teaching
- Being tested
- Real time 'near remote' guidance of regional blocks
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real time 'near remote' guidance of regional blocksProcedure or surgery
Trainees who are to perform regional blocks will do so under expert guidance via tele-mentoring. This will be done using a novel technology consisting of a wirelessly linked iPad which will display the ultrasound image to the block operator/trainee. This image will be concurrently visualized by an expert mentor through their smartphone, who will then provide feedback/guidance in real-time to the operator/trainee.
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant opinion
The investigators will assess the opinions of mentors and trainees regarding the use of 'near-remote' guidance for the performance of ultrasound-guided regional blocks.
Measured: Immediately following block performance
Secondary outcomes (6)
Block success
Patients' sensation to ice
Measured: Within 30 min following block performance
Block image
Saved ultrasound image at the end of the block procedure. Specifically, this image will be saved after completion of local anesthetic injection and before removal of the block needle for subsequent review by a blinded expert.
Measured: Through study completion, an average of 1 year
Complications
Any complications associated with performed regional blocks
Measured: Immediately postoperatively
Patient satisfaction
Patient satisfaction with block performance
Measured: Immediately postoperatively
Number of attempts
Number of attempts to successfully perform regional block
Measured: Immediately following block performance
Participant feedback
Qualitative feedback from trainees and mentors via focus groups
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Glenio Mizubuti (MD, PhD)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Glenio Mizubuti (MD, PhD), Queen's University
- Investigators
- Glenio B. Mizubuti, MD, MSc, FRCPC, Principal investigator, Queen's University. Department of Anesthesiology and Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968261
- Sponsor's protocol ID
- 6038020
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information which will be associated (via study ID number) with each ultrasound image includes: sex, age, BMI range, surgery type and regional block type. The data will be saved directly to a secure server, and subsequently exported to SPSS for analysis. The only identifier will be the study ID number.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Measurement of a Real-time, Near-remote Method to Operationalize Ultrasound-based Regional Anesthesia/Analgesia Procedural Techniques
- ClinicalTrials.gov ID
- NCT05968261
- Acronym / sponsor ID
- 6038020
- Conditions
- Anesthesia, Analgesia, Nerve Block, Delivery of Healthcare, Hospitals, Teaching
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Glenio Mizubuti (MD, PhD)University, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 1 Aug 2023 (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.
Ultrasound-guided regional anesthesia/analgesia techniques (or simply, 'regional blocks') have gained popularity as they can reduce, and sometimes even eliminate, the need for opiate analgesics (and, consequently, their side effects), thereby improving patient safety, reducing length of hospital stay and medical costs, and improving patient satisfaction. However, a major barrier to mainstream uptake of such techniques relates to training. These techniques require the acquisition of new skills under expert guidance, which is often not possible given the daily demands placed upon anesthesiologists. As a result, many opportunities for providing regional blocks may be missed.
The purpose of this study is to implement a new real-time 'near remote' guidance method in which trainees who are to perform regional blocks can do so via tele-mentoring under expert guidance. This will be done using a novel technology whereby the ultrasound image is concurrently displayed on an iPad screen (for the block operator/trainee) as well as on the (near remotely supervising) expert mentor's smartphone. Trainees and mentors will use this method to perform various standard of care regional blocks, either in the perioperative or emergency department settings. Participants' opinions of the novel teaching and learning method will be assessed.
Detailed description
Ultrasound-guided regional anesthesia/analgesia techniques (herein referred to simply as 'regional blocks') have gained popularity as they can reduce, and sometimes even eliminate, the need for opiate analgesics (and, consequently, their side effects), thereby improving patient safety, reducing length of hospital stay and medical costs, and improving patient satisfaction. However, a major barrier to mainstream uptake of such techniques relates to training. These techniques require the acquisition of new skills under expert guidance, which is often not possible given the daily time-sensitive and competing demands placed upon anesthesiologists. Furthermore, staff shortages and increasing demands caused by the COVID-19 pandemic have limited expert availability for one-on-one guidance even more. As a result, many opportunities for providing regional analgesia may be missed or performed in the absence of expert guidance.
Currently, expert staff regional anesthesiologists would ideally be available to supervise regional blocks. In clinical practice, however, if no staff regional anesthesiologist is available to supervise, senior anesthesia residents (post-graduate years 3 to 5) will often proceed with performing lower-risk blocks (e.g., adductor canal blocks) independently provided they feel confident and comfortable with the technique. If, however, the senior anesthesia resident is not comfortable with performing a higher-risk block without supervision, the patient would likely then receive general anesthesia combined with a multimodal analgesic regimen for perioperative pain control.
The purpose of the current study is to implement a new real-time 'near-remote' guidance method, in which trainees who are to perform regional blocks can do so via tele-mentoring under expert guidance. This will be done using an ultrasound-linked iPad which is a novel technology whereby the high-resolution ultrasound image is concurrently displayed on an iPad screen (for the block operator/trainee) as well as on the (near remotely supervising) expert mentor's smartphone. The expert mentor will either be at a distance in the same room or in an adjacent room, but readily available to intervene quickly if necessary. Trainees and mentors will use this method to perform various standard of care regional blocks on patients, either prior to elective surgical procedures or in the emergency department in the context of trauma injuries. All regional blocks will be as per standard of care, except they will be performed under expert 'near-remote' guidance.
Following the regional block performed via tele-mentored expert-guidance, both the trainee and mentor will complete a questionnaire pertaining to that particular block. Questionnaires will be completed electronically via Qualtrics. Block success will also be assessed (i.e., sensory block to ice within 30 min following block performance, as per standard of care) and documented. Towards the end of the study, voluntary focus group sessions will be held, during which trainees and mentors will have the opportunity to provide feedback regarding the newly implemented teaching and learning method. Thematic analyses will then be conducted.
Success with the current study may lay the groundwork for future research investigations to examine the feasibility of guiding such blocks by more remote methods (i.e., with the expert more than a few feet away).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include: (1) mentors, i.e., staff regional anesthesiologists who are experts in ultrasound-guided regional blocks; (2) trainees, i.e., PGY-3 to PGY-5 anesthesia and emergency medicine residents, and emergency medicine staff physicians; and (3) patients, i.e., individuals 18 years and older scheduled for surgery amenable to regional blocks or presenting to the emergency department with traumatic injuries amenable to regional blocks.
Key inclusion criteria (4 listed)
- Mentors: Staff anesthesiologists who are experts in regional blocks.
- Trainees: Senior (PGY3-5) residents (anesthesiology and emergency medicine), and staff (emergency medicine) physicians who have already performed and are comfortable with being supervised near remotely for the regional block at hand.
- Patients: Greater or equal to 18 years of age presenting for surgery or with traumatic injuries amenable to regional blocks.
- All of the above: Able to read and understand English, and competent to provide written informed consent.
Key exclusion criteria (4 listed)
- Mentors: Staff anesthesiologists who are not experts in the performance/teaching of regional blocks.
- Trainees: Junior (PGY1-2) residents (for any/all types of regional blocks), and senior (PGY3-5) residents and staff physicians who are not comfortable with being supervised near remotely for the regional block at hand.
- Patients: Less than 18 years of age.
- All of the above: Unable to read and understand English, and not competent to provide written informed consent.
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 |
|---|---|---|
| Real time 'near remote' guidance of regional blocksTrainees who are to perform regional blocks will do so under expert guidance via tele-mentoring. This will be done using a novel technology consisting of a wirelessly linked iPad which will display the ultrasound image to the block operator/trainee. This image will be concurrently visualized by an expert mentor through their smartphone, who will then provide feedback/guidance in real-time to the operator/trainee. | Procedure or surgery | – |
Primary outcome
Participant opinion
Time frame: Immediately following block performance
The investigators will assess the opinions of mentors and trainees regarding the use of 'near-remote' guidance for the performance of ultrasound-guided regional blocks.
6 secondary outcomes
Block success
Time frame: Within 30 min following block performance
Block image
Time frame: Through study completion, an average of 1 year
Complications
Time frame: Immediately postoperatively
Patient satisfaction
Time frame: Immediately postoperatively
Number of attempts
Time frame: Immediately following block performance
Participant feedback
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Exploring the utility of assistive artificial intelligence for ultrasound scanning in regional anesthesiaLink provided by the sponsor.
- Regional anesthesia training model for resource-limited settings: a prospective single-center observational study with pre-post evaluationsLink provided by the sponsor.
- Application of distant live broadcast in clinical anesthesiology teachingLink provided by the sponsor.
- FaceTime® for teaching ultrasound-guided anesthetic procedures in remote placeLink provided by the sponsor.
- Novel real-time feedback and integrated simulation model for teaching and evaluating ultrasound-guided regional anesthesia skills in pediatric anesthesia traineesLink provided by the sponsor.
- Individual participant dataSharing planned: No. The information which will be associated (via study ID number) with each ultrasound image includes: sex, age, BMI range, surgery type and regional block type. The data will be saved directly to a secure server, and subsequently exported to SPSS for analysis. The only identifier will be the study ID number.
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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.
Glenio B. Mizubuti, MD, MSc, FRCPC principal investigator
Queen's University. Department of Anesthesiology and Perioperative Medicine
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 and Analgesia, run by Dr. Glenio Mizubuti (MD, PhD) 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 4 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Chevrier, MD (6138090424, stephanie.chevrier@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant opinion (time frame: Immediately following block performance). 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 31 Jul 2025.