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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875742
• Other study ID #: 2019/SIMULARTI/ADC
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: May 20, 2019

Study information

• Verified date: June 2019
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Novice interfascial block operators (< 15 interfascial blocks executed)

• informed consent

Exclusion Criteria:

• Exper Interfascial blocks operators

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Ultraplex 360(Braun)
This group will use as first needle the "ultraplex 360" (Braun)
• STIMUPLEX D SH, 30°(Braun)
This group will use as first needle the " STIMUPLEX D SH, 30°" (Braun)

Locations

Country	Name	City	State
Italy	University of Padova	Padova	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Participant Overall Satisfaction	Participants satisfaction with the needle will be evaluated on a 0 to 10 scale at the end of the procedure.	baseline