Single-handed Ultrasound-guided Regional Anaesthesia GripNCT04487366

Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve

A study testing reaching targeted area on the phantom model in people with Single-handed Ultrasound-guided Regional Anaesthesia Grip and Single-operator Ultrasound-guided Peripheric Nerve Block, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Aim of this study is to compare learning curves of single(1- Jedi grip: Pappin and Christie/ 2- Bedforth/ 3- on lock: Gupta and Berrill) and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model. Read more about this study

Who is it for?: Ages 24 to 40 years
Conditions the study is for: Single-handed Ultrasound-guided Regional Anaesthesia Grip, Single-operator Ultrasound-guided Peripheric Nerve Block, Anesthesiology Training
What is being tested?: reaching targeted area on the phantom model
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jul 2020to 1 Oct 2020
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 24 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

To be a junior resident of anesthesiology(< 2 years )

Who cannot join

Refusal of resident

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ankara City Hospital
Ankara, 06600

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve for Anesthesia Residency Training on a Gelatin-based Phantom Model: a Prospective Randomized Controlled Study

Read the detailed description

Ultrasound-guided peripheral blocks are conventionaly performed by double operators. One operator controls both the ultrasound probe and peripheric block needle. Another assistant operator aspirate or injects local anesthetic. In this technique operator do not sense resistance in the syringe. Also this technique requires a well-done communication and coordination between operators.

In order to eliminate disadvantages of this technique several single-operator grip techniques of the needle and syringe have been described(1- Jedi grip: Pappin and Christie/ 2- Bedforth/ 3- on lock: Gupta and Berrill). Single operator techniques allow the provider to perform independently.

Aim of this study is to compare learning curves of single and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model.

Conditions: Single-handed Ultrasound-guided Regional Anaesthesia Grip, Single-operator Ultrasound-guided Peripheric Nerve Block, Anesthesiology Training, Jedi Grip
Being tested: reaching targeted area on the phantom model
Keywords: Jedi Grip, single-operator ultrasound-guided regional anaesthesia grip, Single-handed ultrasound-guided regional anaesthesia, 'On lock' grip, Anesthesiology training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

reaching targeted area on the phantom modelOther
resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution

Study groups in NCT04487366
Study group	Role	What they receive
Double Operator Ultrasound-Guided Regional Anesthesia	Active comparator	resident control block needle and ultrasound probe and asistant operator inject the solution. resident reach the target area created in the phantom model using a block needle with ultrasound guidance Receives: Other: reaching targeted area on the phantom model
Jedi Grip	Active comparator	resident control block needle, ultrasound probe and syringe independently with jedi grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject and aspirate the solution. Receives: Other: reaching targeted area on the phantom model
On-lock grip	Active comparator	resident control block needle, ultrasound probe and syringe independently with on-lock grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject the solution. Receives: Other: reaching targeted area on the phantom model
Bedforth alternative grip	Active comparator	resident control block needle, ultrasound probe and syringe independently with bedforth's alternative grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject the solution. Receives: Other: reaching targeted area on the phantom model

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to correct grip1
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
Measured: during implementation of procedure on phantom model(first session)
image quality1
provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)
Measured: during implementation of procedure on phantom model(first session)
number of attempts1
number of attempts until correct needling to target area
Measured: during implementation of procedure on phantom model(first session)
needling time 1
time to reach target area with block needle
Measured: during implementation of procedure on phantom model(first session)
success of injection1
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
Measured: during implementation of procedure on phantom model(first session)
Time to correct grip2
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
Measured: during implementation of procedure on phantom model(second session)
Time to correct grip3
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
Measured: during implementation of procedure on phantom model(third session)
image quality2
provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)
Measured: during implementation of procedure on phantom model(second session)
image quality3
provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)
Measured: during implementation of procedure on phantom model(third session)
number of attempts2
number of attempts until correct needling to target area
Measured: during implementation of procedure on phantom model(second session)
number of attempts3
number of attempts until correct needling to target area
Measured: during implementation of procedure on phantom model(third session)
needling time 2
time to reach target area with block needle
Measured: during implementation of procedure on phantom model(second session)
needling time 3
time to reach target area with block needle
Measured: during implementation of procedure on phantom model(third session)
success of injection2
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
Measured: during implementation of procedure on phantom model(second session)
success of injection3
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
Measured: during implementation of procedure on phantom model(third session)

Secondary outcomes (2)

NASA-TLX (NASA Task Load Index)
Resident assessment of each techniques for Mental Demand ,Physical Demand, Temporal Demand, Performance, Effort and Frustration
Measured: during implementation of procedure on phantom model(third session)
Assesment of education
Residents assesment of pre-procedural education with a questtionarie. "Education was sufficient enough to safely perform peripheral block":
1. I absolutely agree
2. I approve
3. I am indecisive
4. I do not approve
5. Absolutely Disagree
Measured: during education of techniques

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20201 Oct 2020

First posted27 Jul 2020
Study start1 Jul 2020
Primary completion15 Sep 2020 (estimated)
Study completion1 Oct 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Single-handed Ultrasound-guided Regional Anaesthesia GripStudies 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
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04487366
Sponsor's protocol ID: E1/20-804
Status last verified: Jul 2020
First submitted: 17 Jul 2020
Last updated: 27 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pappin D, Christie I. The Jedi Grip: a novel technique for administering local anaesthetic in ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):845. doi: 10.1111/j.1365-2044.2011.06845.x. No abstract available.
PubMed 21831086
Gupta P, Berrill A. 'On lock' - a further single-operator ultrasound-guided regional anaesthesia grip. Anaesthesia. 2017 Oct;72(10):1289. doi: 10.1111/anae.14050. No abstract available.
PubMed 28891057
Bedforth N, Townsley P, Maybin J, Eisenberg E. Single-handed ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):846. doi: 10.1111/j.1365-2044.2011.06864.x. No abstract available.
PubMed 21831088
Miyake S. Factors influencing mental workload indexes. J UOEH. 1997 Dec 1;19(4):313-25. doi: 10.7888/juoeh.19.313.
PubMed 9431583
Guven Aytac B, Unal S, Aytac I. A randomized, controlled simulation study comparing single and double operator ultrasound-guided regional nerve block techniques using a gelatine-based home-made phantom. Medicine (Baltimore). 2022 Sep 2;101(35):e30368. doi: 10.1097/MD.0000000000030370.
PubMed 36107586

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve for Anesthesia Residency Training on a Gelatin-based Phantom Model: a Prospective Randomized Controlled Study
ClinicalTrials.gov ID: NCT04487366
Acronym / sponsor ID: E1/20-804
Conditions: Single-handed Ultrasound-guided Regional Anaesthesia Grip, Single-operator Ultrasound-guided Peripheric Nerve Block, Anesthesiology Training, Jedi Grip
Keywords: Jedi Grip, single-operator ultrasound-guided regional anaesthesia grip, Single-handed ultrasound-guided regional anaesthesia, 'On lock' grip, Anesthesiology training
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Ankara City Hospital BilkentUniversity, hospital or other
Study start: 1 Jul 2020 (actual)
Primary completion: 15 Sep 2020 (estimated)
Study completion: 1 Oct 2020 (estimated)
First posted: 27 Jul 2020 (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.

Detailed description

Aim of this study is to compare learning curves of single and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Double Operator Ultrasound-Guided Regional Anesthesia	Active comparator	Other: reaching targeted area on the phantom modelresident control block needle and ultrasound probe and asistant operator inject the solution. resident reach the target area created in the phantom model using a block needle with ultrasound guidance
Jedi Grip	Active comparator	Other: reaching targeted area on the phantom modelresident control block needle, ultrasound probe and syringe independently with jedi grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject and aspirate the solution.
On-lock grip	Active comparator	Other: reaching targeted area on the phantom modelresident control block needle, ultrasound probe and syringe independently with on-lock grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject the solution.
Bedforth alternative grip	Active comparator	Other: reaching targeted area on the phantom modelresident control block needle, ultrasound probe and syringe independently with bedforth's alternative grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject the solution.

Who may qualify

Ages: 24 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

To be a junior resident of anesthesiology(< 2 years )

Key exclusion criteria (1 listed)

Refusal of resident

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
reaching targeted area on the phantom modelresident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution	Other	Bedforth alternative grip, Double Operator Ultrasound-Guided Regional Anesthesia, Jedi Grip, On-lock grip

Primary outcome

Time to correct grip1
Time frame: during implementation of procedure on phantom model(first session)
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
image quality1
Time frame: during implementation of procedure on phantom model(first session)
provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)
number of attempts1
Time frame: during implementation of procedure on phantom model(first session)
number of attempts until correct needling to target area
needling time 1
Time frame: during implementation of procedure on phantom model(first session)
time to reach target area with block needle
success of injection1
Time frame: during implementation of procedure on phantom model(first session)
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
Time to correct grip2
Time frame: during implementation of procedure on phantom model(second session)
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
Time to correct grip3
Time frame: during implementation of procedure on phantom model(third session)
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
image quality2
Time frame: during implementation of procedure on phantom model(second session)
provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)
image quality3
Time frame: during implementation of procedure on phantom model(third session)
provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)
number of attempts2
Time frame: during implementation of procedure on phantom model(second session)
number of attempts until correct needling to target area
number of attempts3
Time frame: during implementation of procedure on phantom model(third session)
number of attempts until correct needling to target area
needling time 2
Time frame: during implementation of procedure on phantom model(second session)
time to reach target area with block needle
needling time 3
Time frame: during implementation of procedure on phantom model(third session)
time to reach target area with block needle
success of injection2
Time frame: during implementation of procedure on phantom model(second session)
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
success of injection3
Time frame: during implementation of procedure on phantom model(third session)
successful if injected water flows from hose of model/ unsuccessful if solution do not flow

2 secondary outcomes

NASA-TLX (NASA Task Load Index)
Time frame: during implementation of procedure on phantom model(third session)
Assesment of education
Time frame: during education of techniques

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
Background: PubMed 21831086Pappin D, Christie I. The Jedi Grip: a novel technique for administering local anaesthetic in ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):845. doi: 10.1111/j.1365-2044.2011.06845.x. No abstract available.
Background: PubMed 28891057Gupta P, Berrill A. 'On lock' - a further single-operator ultrasound-guided regional anaesthesia grip. Anaesthesia. 2017 Oct;72(10):1289. doi: 10.1111/anae.14050. No abstract available.
Background: PubMed 21831088Bedforth N, Townsley P, Maybin J, Eisenberg E. Single-handed ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):846. doi: 10.1111/j.1365-2044.2011.06864.x. No abstract available.
Background: PubMed 9431583Miyake S. Factors influencing mental workload indexes. J UOEH. 1997 Dec 1;19(4):313-25. doi: 10.7888/juoeh.19.313.
Derived from this study: PubMed 36107586Guven Aytac B, Unal S, Aytac I. A randomized, controlled simulation study comparing single and double operator ultrasound-guided regional nerve block techniques using a gelatine-based home-made phantom. Medicine (Baltimore). 2022 Sep 2;101(35):e30368. doi: 10.1097/MD.0000000000030370.
Individual participant dataSharing planned: No

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.

İsmail Aytac principal investigator

Ankara City Hospital Anesthesiology Department

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2020. 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 Turkey (Türkiye). 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?

Results are not available in the source record.

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 grip1 (time frame: during implementation of procedure on phantom model(first session)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04487366, which also lists 5 linked publications.

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 27 Jul 2020.