<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04487366</url>
  </required_header>
  <id_info>
    <org_study_id>E1/20-804</org_study_id>
    <nct_id>NCT04487366</nct_id>
  </id_info>
  <brief_title>Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara City Hospital Bilkent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara City Hospital Bilkent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this study is to compare learning curves of single(1- Jedi grip: Pappin and Christie/&#xD;
      2- Bedforth/ 3- on lock: Gupta and Berrill) and double operator ultrasound-guided peripheric&#xD;
      nerve block techniques on a home-made gelatin-based phantom model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ultrasound-guided peripheral blocks are conventionaly performed by double operators. One&#xD;
      operator controls both the ultrasound probe and peripheric block needle. Another assistant&#xD;
      operator aspirate or injects local anesthetic. In this technique operator do not sense&#xD;
      resistance in the syringe. Also this technique requires a well-done communication and&#xD;
      coordination between operators.&#xD;
&#xD;
      In order to eliminate disadvantages of this technique several single-operator grip techniques&#xD;
      of the needle and syringe have been described(1- Jedi grip: Pappin and Christie/ 2- Bedforth/&#xD;
      3- on lock: Gupta and Berrill). Single operator techniques allow the provider to perform&#xD;
      independently.&#xD;
&#xD;
      Aim of this study is to compare learning curves of single and double operator&#xD;
      ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom&#xD;
      model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to correct grip1</measure>
    <time_frame>during implementation of procedure on phantom model(first session)</time_frame>
    <description>Time(sec) from start command to correct grip of the probe, needle and syringe for each technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>image quality1</measure>
    <time_frame>during implementation of procedure on phantom model(first session)</time_frame>
    <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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of attempts1</measure>
    <time_frame>during implementation of procedure on phantom model(first session)</time_frame>
    <description>number of attempts until correct needling to target area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>needling time 1</measure>
    <time_frame>during implementation of procedure on phantom model(first session)</time_frame>
    <description>time to reach target area with block needle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>success of injection1</measure>
    <time_frame>during implementation of procedure on phantom model(first session)</time_frame>
    <description>successful if injected water flows from hose of model/ unsuccessful if solution do not flow</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to correct grip2</measure>
    <time_frame>during implementation of procedure on phantom model(second session)</time_frame>
    <description>Time(sec) from start command to correct grip of the probe, needle and syringe for each technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to correct grip3</measure>
    <time_frame>during implementation of procedure on phantom model(third session)</time_frame>
    <description>Time(sec) from start command to correct grip of the probe, needle and syringe for each technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>image quality2</measure>
    <time_frame>during implementation of procedure on phantom model(second session)</time_frame>
    <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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>image quality3</measure>
    <time_frame>during implementation of procedure on phantom model(third session)</time_frame>
    <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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of attempts2</measure>
    <time_frame>during implementation of procedure on phantom model(second session)</time_frame>
    <description>number of attempts until correct needling to target area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of attempts3</measure>
    <time_frame>during implementation of procedure on phantom model(third session)</time_frame>
    <description>number of attempts until correct needling to target area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>needling time 2</measure>
    <time_frame>during implementation of procedure on phantom model(second session)</time_frame>
    <description>time to reach target area with block needle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>needling time 3</measure>
    <time_frame>during implementation of procedure on phantom model(third session)</time_frame>
    <description>time to reach target area with block needle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>success of injection2</measure>
    <time_frame>during implementation of procedure on phantom model(second session)</time_frame>
    <description>successful if injected water flows from hose of model/ unsuccessful if solution do not flow</description>
  </primary_outcome>
  <primary_outcome>
    <measure>success of injection3</measure>
    <time_frame>during implementation of procedure on phantom model(third session)</time_frame>
    <description>successful if injected water flows from hose of model/ unsuccessful if solution do not flow</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NASA-TLX (NASA Task Load Index)</measure>
    <time_frame>during implementation of procedure on phantom model(third session)</time_frame>
    <description>Resident assessment of each techniques for Mental Demand ,Physical Demand, Temporal Demand, Performance, Effort and Frustration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assesment of education</measure>
    <time_frame>during education of techniques</time_frame>
    <description>Residents assesment of pre-procedural education with a questtionarie. &quot;Education was sufficient enough to safely perform peripheral block&quot;:&#xD;
I absolutely agree&#xD;
I approve&#xD;
I am indecisive&#xD;
I do not approve&#xD;
Absolutely Disagree</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Single-handed Ultrasound-guided Regional Anaesthesia Grip</condition>
  <condition>Single-operator Ultrasound-guided Peripheric Nerve Block</condition>
  <condition>Anesthesiology Training</condition>
  <condition>Jedi Grip</condition>
  <arm_group>
    <arm_group_label>Double Operator Ultrasound-Guided Regional Anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Jedi Grip</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>On-lock grip</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bedforth alternative grip</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>reaching targeted area on the phantom model</intervention_name>
    <description>resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution</description>
    <arm_group_label>Bedforth alternative grip</arm_group_label>
    <arm_group_label>Double Operator Ultrasound-Guided Regional Anesthesia</arm_group_label>
    <arm_group_label>Jedi Grip</arm_group_label>
    <arm_group_label>On-lock grip</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - To be a junior resident of anesthesiology(&lt; 2 years )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of resident&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>İsmail Aytac</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ankara City Hospital Anesthesiology Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara City Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06600</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>21831086</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28891057</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21831088</PMID>
  </reference>
  <reference>
    <citation>Miyake S. Factors influencing mental workload indexes. J UOEH. 1997 Dec 1;19(4):313-25. doi: 10.7888/juoeh.19.313.</citation>
    <PMID>9431583</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
    <investigator_full_name>ismail aytaç</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Jedi Grip</keyword>
  <keyword>single-operator ultrasound-guided regional anaesthesia grip</keyword>
  <keyword>Single-handed ultrasound-guided regional anaesthesia</keyword>
  <keyword>'On lock' grip</keyword>
  <keyword>Anesthesiology training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04487366
org study id: E1/20-804
nct id: NCT04487366
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Time to correct grip1
time frame: during implementation of procedure on phantom model(first session)
description: Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
measure: image quality1
time frame: during implementation of procedure on phantom model(first session)
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)
measure: number of attempts1
time frame: during implementation of procedure on phantom model(first session)
description: number of attempts until correct needling to target area
measure: needling time 1
time frame: during implementation of procedure on phantom model(first session)
description: time to reach target area with block needle
measure: success of injection1
time frame: during implementation of procedure on phantom model(first session)
description: successful if injected water flows from hose of model/ unsuccessful if solution do not flow
measure: Time to correct grip2
time frame: during implementation of procedure on phantom model(second session)
description: Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
measure: Time to correct grip3
time frame: during implementation of procedure on phantom model(third session)
description: Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
measure: image quality2
time frame: during implementation of procedure on phantom model(second session)
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)
measure: image quality3
time frame: during implementation of procedure on phantom model(third session)
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)
measure: number of attempts2
time frame: during implementation of procedure on phantom model(second session)
description: number of attempts until correct needling to target area
measure: number of attempts3
time frame: during implementation of procedure on phantom model(third session)
description: number of attempts until correct needling to target area
measure: needling time 2
time frame: during implementation of procedure on phantom model(second session)
description: time to reach target area with block needle
measure: needling time 3
time frame: during implementation of procedure on phantom model(third session)
description: time to reach target area with block needle
measure: success of injection2
time frame: during implementation of procedure on phantom model(second session)
description: successful if injected water flows from hose of model/ unsuccessful if solution do not flow
measure: success of injection3
time frame: during implementation of procedure on phantom model(third session)
description: successful if injected water flows from hose of model/ unsuccessful if solution do not flow
measure: NASA-TLX (NASA Task Load Index)
time frame: during implementation of procedure on phantom model(third session)
description: Resident assessment of each techniques for Mental Demand ,Physical Demand, Temporal Demand, Performance, Effort and Frustration
measure: Assesment of education
time frame: during education of techniques
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
arm group label: Double Operator Ultrasound-Guided Regional Anesthesia
arm group type: Active Comparator
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 group label: Jedi Grip
arm group type: Active Comparator
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 group label: On-lock grip
arm group type: Active Comparator
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 group label: Bedforth alternative grip
arm group type: Active Comparator
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: reaching targeted area on the phantom model
description: resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution
arm group label: Bedforth alternative grip
arm group label: Double Operator Ultrasound-Guided Regional Anesthesia
arm group label: Jedi Grip
arm group label: On-lock grip
criteria: 
gender: All
minimum age: 24 Years
maximum age: 40 Years
healthy volunteers: No
last name: İsmail Aytac
role: Principal Investigator
affiliation: Ankara City Hospital Anesthesiology Department
facility: 
country: Turkey
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.
PMID: 21831086
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.
PMID: 28891057
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.
PMID: 21831088
citation: Miyake S. Factors influencing mental workload indexes. J UOEH. 1997 Dec 1;19(4):313-25. doi: 10.7888/juoeh.19.313.
PMID: 9431583
responsible party type: Principal Investigator
investigator affiliation: Ankara City Hospital Bilkent
investigator full name: ismail aytaç
investigator title: Principal Investigator
mesh term: Influenza, Human
sharing ipd: No