NCT04487366

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

July 17, 2020

Last Update Submit

July 22, 2020

Conditions

Keywords

Jedi Gripsingle-operator ultrasound-guided regional anaesthesia gripSingle-handed ultrasound-guided regional anaesthesia'On lock' gripAnesthesiology training

Outcome Measures

Primary Outcomes (15)

  • Time to correct grip1

    Time(sec) from start command to correct grip of the probe, needle and syringe for each technique

    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)

    during implementation of procedure on phantom model(first session)

  • number of attempts1

    number of attempts until correct needling to target area

    during implementation of procedure on phantom model(first session)

  • needling time 1

    time to reach target area with block needle

    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

    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

    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

    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)

    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)

    during implementation of procedure on phantom model(third session)

  • number of attempts2

    number of attempts until correct needling to target area

    during implementation of procedure on phantom model(second session)

  • number of attempts3

    number of attempts until correct needling to target area

    during implementation of procedure on phantom model(third session)

  • needling time 2

    time to reach target area with block needle

    during implementation of procedure on phantom model(second session)

  • needling time 3

    time to reach target area with block needle

    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

    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

    during implementation of procedure on phantom model(third session)

Secondary Outcomes (2)

  • NASA-TLX (NASA Task Load Index)

    during implementation of procedure on phantom model(third session)

  • Assesment of education

    during education of techniques

Study Arms (4)

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

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.

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.

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.

Other: reaching targeted area on the phantom model

Interventions

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

Bedforth alternative gripDouble Operator Ultrasound-Guided Regional AnesthesiaJedi GripOn-lock grip

Eligibility Criteria

Age24 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Refusal of resident

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06600, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 21831086BACKGROUND
  • 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.

    PMID: 28891057BACKGROUND
  • 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.

    PMID: 21831088BACKGROUND
  • Miyake S. Factors influencing mental workload indexes. J UOEH. 1997 Dec 1;19(4):313-25. doi: 10.7888/juoeh.19.313.

    PMID: 9431583BACKGROUND
  • 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.

Study Officials

  • İsmail Aytac

    Ankara City Hospital Anesthesiology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 27, 2020

Study Start

July 1, 2020

Primary Completion

September 15, 2020

Study Completion

October 1, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations