Simulation-based Training for Ultrasound-guided Popliteal Sciatic Nerve Block

Simulation-based Training for Ultrasound-guided Popliteal Sciatic Nerve Block Performance: a Randomized Non-inferiority Study Comparing Direct Synchronous Feedback With Remote Asynchronous Feedback

The goal of this study is to evaluate whether remote asynchronous feedback is non-inferior to direct synchronous feedback during simulation-based training for ultrasound-guided popliteal sciatic nerve block performance. The main questions it aims to answer are:

Does asynchronous feedback achieve technical skill acquisition outcomes comparable to direct synchronous feedback? Can asynchronous feedback optimize teaching resources without compromising training quality?

Researchers will compare two feedback modalities within a simulation-based training program for deliberate practice of ultrasound-guided popliteal sciatic nerve block techniques.

Participants will:

Receive training with either direct synchronous feedback or remote asynchronous feedback Perform simulation-based deliberate practice sessions Be assessed using validated instruments for technical skill performance

Study Overview

Detailed Description

For the use of the simulation program based on the implementation of a continuous sciatic popliteal nerve block. To achieve this, a simulation program developed by researchers from the School of Medicine of the Pontificia Universidad Católica de Chile will be used for residents from the Emergency Medicine and Critical Care specialty program.

Following approval by the institutional ethics committee, the scenario for 50 students will be prepared. The procedure room will include all the equipment required for performing the intervention, consisting of a video explaining the technique. The study will assess:

(i) Fundamentals and use of echography. (ii) Knowledge of anatomy, physiology, and pharmacology. (iii) Development of dexterity: ability to perform the procedure correctly.

The students will receive a one-hour lecture on the procedure. This assessment will consist of performing a sciatic popliteal nerve block on a simulated clinical scenario. An evaluator blinded to the study objectives will assess participants using a Global Rating Scale (GRS) and a checklist. Additionally, a third evaluator will use the GRS and the checklist remotely (asynchronous feedback).

After the evaluations, the simulation room will remain open throughout the week for students to perform up to five practice sessions. The number of movements and total procedure time will be recorded during each assessment. Students will also complete a satisfaction questionnaire and a final written test after the simulation activity and before the final assessment.

Once the previous evaluation is completed, residents may begin their training.

Subsequently, residents will attend simulation sessions specifically designed to practice the sciatic popliteal nerve block under the guidance of an instructor. Sessions will last 2 hours. Each resident will complete 2 sessions, each separated by 1 week. During the first session, the instructor will explain and supervise correct use of the ultrasound equipment. During the second session, the resident will perform the entire procedure independently. The resident's performance will be recorded and later evaluated through an assessment platform.

One week after training completion, residents will undergo a final assessment using the same tools. The duration of the simulation-based sciatic popliteal nerve block procedure will be recorded. Total procedure time and the number of movements performed during the procedure will also be documented. Additionally, the procedure will be video recorded.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7700950
        • Recruiting
        • Pontificia Universidad Catolica de Chile
        • Contact:
        • Contact:
          • Pablo Miranda, Assistant professor

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medicine students

Exclusion Criteria:

  • No exclusion Criteria

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Synchronous direct feedback (SYNC)
The control group practiced with synchronous direct feedback (SYNC). The SYNC group attended the simulation laboratory for practice sessions. Residents were scheduled to practice with the instructor in a one-to-one ses- sion. The instructor was present during all the sessions and gave instructions and feedback in real time throughout all sessions (traditional face-to-face feedback modality).
The control group practiced with SYNC. The SYNC group attended the simulation laboratory for practice sessions. Residents were scheduled to practice with the instructor in a one-to-one ses- sion. The instructor was present during all the sessions and gave instructions and feedback in real time throughout all sessions (traditional face-to-face feedback modality).
Experimental: Asynchronous distance feedback (ASYNC).
The experimental group practiced with asynchronous distance feedback (ASYNC). Residents scheduled their sessions and attended the simulation laboratory alone. The resident logged in to the C1DO1 platform.The student recorded himself, performing the observed technique. The instructor was not present and provided feedback asynchronously via a C1DO1 platform. The ASYNC included texts, audio recordings, drawings annotating the trainee's video, and short example error videos from a library. In addition to the specific feedback in response to residents' videos, instructors also provided an objective assessment based on scores using a 9-item global rating scale (GRS). The student reviewed their feedback in the platform and identified the skills to improve for the next session.
The experimental group practiced with ASYNC. Residents sched- uled their sessions and attended the simulation laboratory alone. The resident logged in to the C1DO1 platform. In the platform, the second 4 stages were practical exercises. The student recorded himself, performing the observed technique.9 The instructor was not present and provided feedback asynchronously via a C1DO1 platform. The ASYNC included texts, audio recordings, drawings annotating the trainee's video, and short example error videos from a library. In addition to the specific feedback in response to residents' videos, instructors also provided an objective assessment based on scores using a 9-item global rating scale (GRS). The student reviewed their feedback in the platform and identified the skills to improve for the next session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance assessment
Time Frame: 8 weeks
The PRE and POST assessments were videotaped for evaluation by 2 independent and blinded reviewers. The simulation center staff recorded the assessment videos for a standard vision of the participant's hands and the ultrasound image. Two reviewers rated each resident's performance using an specific GRS previously validated. The reviewers were different from the instructors.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICSAD measurement
Time Frame: 8 weeks
Two sensors of a tracking motion device were attached to the operator's hands, during the assess- ment. The Imperial College Surgical Assessment Device (ICSAD) is a device that tracks hand motion during a procedure using sensors placed on the back of the operator's hands. In this study, the ICSAD device recorded the total distance traveled by both hands (TPL). The simulation center staff installed the device in the operators' hands and recorded the data.
8 weeks

Collaborators and Investigators

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

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 (Actual)

May 28, 2026

Primary Completion (Estimated)

December 27, 2026

Study Completion (Estimated)

March 27, 2027

Study Registration Dates

First Submitted

May 28, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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