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

June 1, 2019 updated by: Alessandro De Cassai, University of Padova
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Veneto
      • Padova, Veneto, Italy, 35127
        • University of Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Exper Interfascial blocks operators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: "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)
Device: Ultraplex 360(Braun)
This group will use as first needle the "ultraplex 360" (Braun)
Other: " 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)
Device: STIMUPLEX D SH, 30°(Braun)
This group will use as first needle the " STIMUPLEX D SH, 30°" (Braun)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Actual)

May 20, 2019

Study Completion (Actual)

May 20, 2019

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 1, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019/SIMULARTI/ADC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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