Near Remote Method to Guide Performance of Regional Anesthesia

July 28, 2025 updated by: Dr. Glenio Mizubuti (MD, PhD)

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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

200

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 Contact Backup

  • Name: Glenio B. Mizubuti, MD
  • Phone Number: (613) 548-7827
  • Email: gm75@queensu.ca

Study Locations

    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Recruiting
        • Hotel Dieu Hospital site (primary) and Kingston General Hospital site (secondary), Kingston Health Sciences Centre
        • Contact:
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately following block performance

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block success
Time Frame: Within 30 min following block performance
Patients' sensation to ice
Within 30 min following block performance
Block image
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
Complications
Time Frame: Immediately postoperatively
Any complications associated with performed regional blocks
Immediately postoperatively
Patient satisfaction
Time Frame: Immediately postoperatively
Patient satisfaction with block performance
Immediately postoperatively
Number of attempts
Time Frame: Immediately following block performance
Number of attempts to successfully perform regional block
Immediately following block performance
Participant feedback
Time Frame: Through study completion, an average of 1 year
Qualitative feedback from trainees and mentors via focus groups
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Glenio B. Mizubuti, MD, MSc, FRCPC, Queen's University. Department of Anesthesiology and Perioperative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 6038020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Analgesia

Clinical Trials on Real time 'near remote' guidance of regional blocks

Subscribe