AnesthesiaNCT03875742
Interfascial Blocks Executed by Novice Operators in a Simulator Model: a Comparison of Two Types of Needles
A study testing Ultraplex 360(Braun) and STIMUPLEX D SH, 30°(Braun) in people with Anesthesia, run by University of Padova at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Ultraplex 360(Braun) and STIMUPLEX D SH, 30°(Braun)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2019to 20 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Novice interfascial block operators (< 15 interfascial blocks executed)
- informed consent
Who cannot join
- Exper Interfascial blocks operators
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Ultraplex 360(Braun), STIMUPLEX D SH, 30°(Braun)
- Keywords
- simulation, interfascial blocks, TAP block, needles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| "Ultraplex 360" | Other | This group will execute the first TAP block using "Ultraplex 360" (Braun) and the second TAP block using " STIMUPLEX D SH, 30°" (Braun) Receives: Device: Ultraplex 360(Braun) |
| " STIMUPLEX D SH, 30°" | Other | This group will execute the first TAP block using " STIMUPLEX D SH, 30°" (Braun) and the second TAP block using "Ultraplex 360" (Braun) Receives: Device: STIMUPLEX D SH, 30°(Braun) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (2)
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.
Measured: baseline
Participant Overall Satisfaction
Participants satisfaction with the needle will be evaluated on a 0 to 10 scale at the end of the procedure.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start20 May 2019
- Primary completion20 May 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875742
- Sponsor's protocol ID
- 2019/SIMULARTI/ADC
- Status last verified
- Jun 2019
- First submitted
- 22 Feb 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interfascial Blocks Executed by Novice Operators in a Simulator Model: a Comparison of Two Types of Needles
- ClinicalTrials.gov ID
- NCT03875742
- Acronym / sponsor ID
- 2019/SIMULARTI/ADC
- Conditions
- Anesthesia
- Keywords
- simulation, interfascial blocks, TAP block, needles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| "Ultraplex 360" | Other | Device: Ultraplex 360(Braun)This group will execute the first TAP block using "Ultraplex 360" (Braun) and the second TAP block using " STIMUPLEX D SH, 30°" (Braun) |
| " STIMUPLEX D SH, 30°" | Other | Device: STIMUPLEX D SH, 30°(Braun)This group will execute the first TAP block using " STIMUPLEX D SH, 30°" (Braun) and the second TAP block using "Ultraplex 360" (Braun) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Novice interfascial block operators (< 15 interfascial blocks executed)
- informed consent
Key exclusion criteria (1 listed)
- Exper Interfascial blocks operators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultraplex 360(Braun)This group will use as first needle the "ultraplex 360" (Braun) | Device | "Ultraplex 360" |
| STIMUPLEX D SH, 30°(Braun)This group will use as first needle the " STIMUPLEX D SH, 30°" (Braun) | Device | " STIMUPLEX D SH, 30°" |
Primary outcome
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.
2 secondary outcomes
Needle tip visualization
Time frame: baseline
Participant Overall Satisfaction
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraplex 360(Braun) and STIMUPLEX D SH, 30°(Braun) in people with Anesthesia, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to correct block execution (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.