Interfascial Blocks Executed by Novice Operators in a Simulator Model: a Comparison of Two Types of Needles

Study Overview
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Brief Summary
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This study will compare two different needles for interfascial blocks. All participants will execute the block on simulator with both needles. The participants will be randomized in two groups to choose the starting needle.

Detailed Description
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Interfascial blocks are an emerging field of anesthesia. They are executed injecting local anesthetics inside a fascia plane using a needle. Actually no evidence supports the use of a needle upon one other. Investigators would like to compare Ultraplex 360® (Braun) needle with  STIMUPLEX D SH, 30°(Braun) while performing a Trasversus Abdominis Plane Block on BluePhantom simulator. Ultraplex 360® (Braun) has an innovative surface pattern and clear coating that could result in better ultrasound visualization and tip identification.

Official Title
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Interfascial Blocks Executed by Novice Operators in a Simulator Model: a Comparison of Two Types of Needles

Conditions
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Anesthesia

Intervention / Treatment
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* Device: Ultraplex 360(Braun)
* Device: STIMUPLEX D SH, 30°(Braun)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Novice interfascial block operators (< 15 interfascial blocks executed) informed consent Exclusion Criteria: Exper Interfascial blocks operators
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 70 anesthesia residents with low experience in interfascial blocks ( less than 15 interfascial blocks)will be asked to execute a Trasversus Abdominis Plane Block on Trasversus Abdominis Plane Block Ultrasound Training Model (BluePhantom) two times and they will be randomized in two groups. First group will execute the first Trasversus Abdominis Plane Block using UltraPlex 360(Braun) and the second Trasversus Abdominis Plane Block using STIMUPLEX D SH, 30°(Braun). Second group will execute the first Trasversus Abdominis Plane Block using STIMUPLEX D SH, 30°(Braun) and the second Trasversus Abdominis Plane Block using Ultraplex(Braun).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ultraplex 360<br>This group will execute the first TAP block using Ultraplex 360 (Braun) and the second TAP block using  STIMUPLEX D SH, 30° (Braun) | Device: Ultraplex 360(Braun)<br>* This group will use as first needle the ultraplex 360 (Braun)<br>|
| Other:  STIMUPLEX D SH, 30°<br>This group will execute the first TAP block using  STIMUPLEX D SH, 30° (Braun) and the second TAP block using Ultraplex 360 (Braun) | Device: STIMUPLEX D SH, 30°(Braun)<br>* This group will use as first needle the  STIMUPLEX D SH, 30° (Braun)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to correct block execution | Investigators will measure time needed to correctly perform the block in seconds. The chronometer will be started when the participant takes the ultrasound probe and will be stopped when 10 ml saline has been fully injected. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle tip visualization | Procedure will be recorded as a clip in ultrasound machine. Investigators will evaluate the time(seconds) during the procedure with a clear tip visualization. This time will be divided per total procedure time. | baseline | 
| Participant Overall Satisfaction | Participants satisfaction with the needle will be evaluated on a 0 to 10 scale at the end of the procedure. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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simulation, interfascial blocks, TAP block, needles