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

Primary Purpose

Single-handed Ultrasound-guided Regional Anaesthesia Grip, Single-operator Ultrasound-guided Peripheric Nerve Block, Anesthesiology Training

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
reaching targeted area on the phantom model
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Single-handed Ultrasound-guided Regional Anaesthesia Grip focused on measuring Jedi Grip, single-operator ultrasound-guided regional anaesthesia grip, Single-handed ultrasound-guided regional anaesthesia, 'On lock' grip, Anesthesiology training

Eligibility Criteria

24 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of resident

Sites / Locations

  • Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Double Operator Ultrasound-Guided Regional Anesthesia

Jedi Grip

On-lock grip

Bedforth alternative grip

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

Time to correct grip1
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
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)
number of attempts1
number of attempts until correct needling to target area
needling time 1
time to reach target area with block needle
success of injection1
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
Time to correct grip2
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
Time to correct grip3
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
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)
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)
number of attempts2
number of attempts until correct needling to target area
number of attempts3
number of attempts until correct needling to target area
needling time 2
time to reach target area with block needle
needling time 3
time to reach target area with block needle
success of injection2
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
success of injection3
successful if injected water flows from hose of model/ unsuccessful if solution do not flow

Secondary Outcome Measures

NASA-TLX (NASA Task Load Index)
Resident assessment of each techniques for Mental Demand ,Physical Demand, Temporal Demand, Performance, Effort and Frustration
Assesment of education
Residents assesment of pre-procedural education with a questtionarie. "Education was sufficient enough to safely perform peripheral block": I absolutely agree I approve I am indecisive I do not approve Absolutely Disagree

Full Information

First Posted
July 17, 2020
Last Updated
July 22, 2020
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT04487366
Brief Title
Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
September 15, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double Operator Ultrasound-Guided Regional Anesthesia
Arm Type
Active Comparator
Arm Description
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
Arm Title
Jedi Grip
Arm Type
Active Comparator
Arm Description
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.
Arm Title
On-lock grip
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bedforth alternative grip
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
reaching targeted area on the phantom model
Intervention Description
resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution
Primary Outcome Measure Information:
Title
Time to correct grip1
Description
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
Time Frame
during implementation of procedure on phantom model(first session)
Title
image quality1
Description
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)
Time Frame
during implementation of procedure on phantom model(first session)
Title
number of attempts1
Description
number of attempts until correct needling to target area
Time Frame
during implementation of procedure on phantom model(first session)
Title
needling time 1
Description
time to reach target area with block needle
Time Frame
during implementation of procedure on phantom model(first session)
Title
success of injection1
Description
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
Time Frame
during implementation of procedure on phantom model(first session)
Title
Time to correct grip2
Description
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
Time Frame
during implementation of procedure on phantom model(second session)
Title
Time to correct grip3
Description
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
Time Frame
during implementation of procedure on phantom model(third session)
Title
image quality2
Description
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)
Time Frame
during implementation of procedure on phantom model(second session)
Title
image quality3
Description
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)
Time Frame
during implementation of procedure on phantom model(third session)
Title
number of attempts2
Description
number of attempts until correct needling to target area
Time Frame
during implementation of procedure on phantom model(second session)
Title
number of attempts3
Description
number of attempts until correct needling to target area
Time Frame
during implementation of procedure on phantom model(third session)
Title
needling time 2
Description
time to reach target area with block needle
Time Frame
during implementation of procedure on phantom model(second session)
Title
needling time 3
Description
time to reach target area with block needle
Time Frame
during implementation of procedure on phantom model(third session)
Title
success of injection2
Description
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
Time Frame
during implementation of procedure on phantom model(second session)
Title
success of injection3
Description
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
Time Frame
during implementation of procedure on phantom model(third session)
Secondary Outcome Measure Information:
Title
NASA-TLX (NASA Task Load Index)
Description
Resident assessment of each techniques for Mental Demand ,Physical Demand, Temporal Demand, Performance, Effort and Frustration
Time Frame
during implementation of procedure on phantom model(third session)
Title
Assesment of education
Description
Residents assesment of pre-procedural education with a questtionarie. "Education was sufficient enough to safely perform peripheral block": I absolutely agree I approve I am indecisive I do not approve Absolutely Disagree
Time Frame
during education of techniques

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - To be a junior resident of anesthesiology(< 2 years ) Exclusion Criteria: Refusal of resident
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İsmail Aytac
Organizational Affiliation
Ankara City Hospital Anesthesiology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06600
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21831086
Citation
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.
Results Reference
background
PubMed Identifier
28891057
Citation
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.
Results Reference
background
PubMed Identifier
21831088
Citation
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.
Results Reference
background
PubMed Identifier
9431583
Citation
Miyake S. Factors influencing mental workload indexes. J UOEH. 1997 Dec 1;19(4):313-25. doi: 10.7888/juoeh.19.313.
Results Reference
background
PubMed Identifier
36107586
Citation
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.
Results Reference
derived

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

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