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

NCT03875742 | Completed

• 1 other identifier: 2019/SIMULARTI/ADC
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia

Keywords

simulation; interfascial blocks; TAP block; needles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Needle tip visualization

  baseline

• Participant Overall Satisfaction

  baseline

Study Arms (2)

"Ultraplex 360"

OTHER

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)

" STIMUPLEX D SH, 30°"

OTHER

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)

Interventions

Ultraplex 360(Braun) DEVICE

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

"Ultraplex 360"

STIMUPLEX D SH, 30°(Braun) DEVICE

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

" STIMUPLEX D SH, 30°"

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Exper Interfascial blocks operators

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University of Padova

Padua, Veneto, 35127, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 15, 2019
• Study Start: May 20, 2019
• Primary Completion: May 20, 2019
• Study Completion: May 20, 2019
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

IT (1)