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

NCT ID: NCT03875742

Last Updated: 2019-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2019-05-20

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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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"Ultraplex 360"

This group will execute the first TAP block using "Ultraplex 360" (Braun) and the second TAP block using " STIMUPLEX D SH, 30°" (Braun)

Group Type OTHER

Ultraplex 360(Braun)

Intervention Type DEVICE

This group will use as first needle the "ultraplex 360" (Braun)

" STIMUPLEX D SH, 30°"

This group will execute the first TAP block using " STIMUPLEX D SH, 30°" (Braun) and the second TAP block using "Ultraplex 360" (Braun)

Group Type OTHER

STIMUPLEX D SH, 30°(Braun)

Intervention Type DEVICE

This group will use as first needle the " STIMUPLEX D SH, 30°" (Braun)

Interventions

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Ultraplex 360(Braun)

This group will use as first needle the "ultraplex 360" (Braun)

Intervention Type DEVICE

STIMUPLEX D SH, 30°(Braun)

This group will use as first needle the " STIMUPLEX D SH, 30°" (Braun)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Novice interfascial block operators (\< 15 interfascial blocks executed)
* informed consent

Exclusion Criteria

* Exper Interfascial blocks operators
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Alessandro De Cassai

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Padova

Padua, Veneto, Italy

Site Status

Countries

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Italy

Other Identifiers

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2019/SIMULARTI/ADC

Identifier Type: -

Identifier Source: org_study_id

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