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

July 22, 2020 updated by: ismail aytaç, Ankara City Hospital Bilkent

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06600
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of resident

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Double Operator Ultrasound-Guided Regional Anesthesia
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 reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution
Active Comparator: Jedi Grip
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 reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution
Active Comparator: On-lock grip
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 reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution
Active Comparator: Bedforth alternative grip
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.
resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during implementation of procedure on phantom model(first session)
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)
during implementation of procedure on phantom model(first session)
number of attempts1
Time Frame: during implementation of procedure on phantom model(first session)
number of attempts until correct needling to target area
during implementation of procedure on phantom model(first session)
needling time 1
Time Frame: during implementation of procedure on phantom model(first session)
time to reach target area with block needle
during implementation of procedure on phantom model(first session)
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
during implementation of procedure on phantom model(first session)
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
during implementation of procedure on phantom model(second session)
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
during implementation of procedure on phantom model(third session)
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)
during implementation of procedure on phantom model(second session)
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)
during implementation of procedure on phantom model(third session)
number of attempts2
Time Frame: during implementation of procedure on phantom model(second session)
number of attempts until correct needling to target area
during implementation of procedure on phantom model(second session)
number of attempts3
Time Frame: during implementation of procedure on phantom model(third session)
number of attempts until correct needling to target area
during implementation of procedure on phantom model(third session)
needling time 2
Time Frame: during implementation of procedure on phantom model(second session)
time to reach target area with block needle
during implementation of procedure on phantom model(second session)
needling time 3
Time Frame: during implementation of procedure on phantom model(third session)
time to reach target area with block needle
during implementation of procedure on phantom model(third session)
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
during implementation of procedure on phantom model(second session)
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
during implementation of procedure on phantom model(third session)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NASA-TLX (NASA Task Load Index)
Time Frame: during implementation of procedure on phantom model(third session)
Resident assessment of each techniques for Mental Demand ,Physical Demand, Temporal Demand, Performance, Effort and Frustration
during implementation of procedure on phantom model(third session)
Assesment of education
Time Frame: during education of techniques

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
during education of techniques

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: İsmail Aytac, Ankara City Hospital Anesthesiology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

September 15, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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