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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03875742
Other study ID # 2019/SIMULARTI/ADC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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