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

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ClinicalTrials.gov Identifier: NCT03875742
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Alessandro De Cassai, University of Padova

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anesthesia Device: Ultraplex 360(Braun) Device: STIMUPLEX D SH, 30°(Braun) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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).
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Interfascial Blocks Executed by Novice Operators in a Simulator Model: a Comparison of Two Types of Needles
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : May 20, 2019
Actual Study Completion Date : May 20, 2019
Arms and Interventions
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Arm Intervention/treatment
"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)
" 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)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Exper Interfascial blocks operators
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875742


Locations
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Italy
University of Padova
Padova, Veneto, Italy, 35127
Sponsors and Collaborators
University of Padova
More Information
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Responsible Party: Alessandro De Cassai, Principal Investigator, University of Padova
ClinicalTrials.gov Identifier: NCT03875742    
Other Study ID Numbers: 2019/SIMULARTI/ADC
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessandro De Cassai, University of Padova:
simulation
interfascial blocks
TAP block
needles