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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03875742
Enrollment
70
Registered
2019-03-15
Start date
2019-05-20
Completion date
2019-05-20
Last updated
2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

simulation, interfascial blocks, TAP block, needles

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.

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.

Interventions

DEVICEUltraplex 360(Braun)

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

DEVICESTIMUPLEX D SH, 30°(Braun)

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

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

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).

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Exper Interfascial blocks operators

Design outcomes

Primary

MeasureTime frameDescription
Time to correct block executionbaselineInvestigators 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

MeasureTime frameDescription
Needle tip visualizationbaselineProcedure 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.
Participant Overall SatisfactionbaselineParticipants satisfaction with the needle will be evaluated on a 0 to 10 scale at the end of the procedure.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026