Skip to main content
OpenTrials
Completed

NCT Number: NCT03875742

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Padova

Padova, Veneto, 35127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Exper Interfascial blocks operators

Treatment and study plan

Ultraplex 360(Braun)

Device

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

STIMUPLEX D SH, 30°(Braun)

Device

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

Primary outcomes

  1. Time to correct block execution

    Time frame: baseline

    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.

Secondary outcomes

  1. Needle tip visualization

    Time frame: baseline

    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.

  2. Participant Overall Satisfaction

    Time frame: baseline

    Participants satisfaction with the needle will be evaluated on a 0 to 10 scale at the end of the procedure.

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2019
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.