<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/NCT04471025</url>
  </required_header>
  <id_info>
    <org_study_id>E-18-1935</org_study_id>
    <nct_id>NCT04471025</nct_id>
  </id_info>
  <brief_title>Jedi Grip Versus Double Operator Technique For Ultrasound Guided Infraclavicular Block</brief_title>
  <official_title>A Prospective, Randomized, Observer-Blinded Comparison Between Single And Double Operator In Ultrasound Guided Infraclavicular Block: Jedi Grip Versus Conventional Double Operator Technique</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>
      The investigators aimed to compare the block characteristics of the single operator &quot;jedi&#xD;
      grip&quot; technique and the conventional double operator technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing hand, wrist, elbow and forearm surgery randomly assigned two groups&#xD;
      (Group I: Jedi grip and Group II: Conventional double operator technique). By a blind&#xD;
      observer, the block characteristics were evaluated and recorded .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 14, 2018</start_date>
  <completion_date type="Actual">May 3, 2019</completion_date>
  <primary_completion_date type="Actual">May 3, 2019</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>Parallel Assignment</intervention_model>
    <intervention_model_description>single-center, prospective, randomized into two goups: Jedi grip versus conventional double operator technique</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>After completion of the block, a single blinded observer recorded demographic data and evaluated the block characteristics</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>block performance time</measure>
    <time_frame>during block application</time_frame>
    <description>teh sum of imaging and needling time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>block success</measure>
    <time_frame>during surgery</time_frame>
    <description>incidence of ( %) surgery with successful anesthesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensory block onset time</measure>
    <time_frame>before surgery</time_frame>
    <description>Sensory blockage was evaluated and graded; from lateral to the forearm, the volar face of the thumb, volar face of the 5th finger and lateral side of the hand back; for musculocutaneous, median, ulnar and radial nerves, respectively. Graduation was according to a previously validated 3-point scale using a cold test: 0 = no block, 1 = analgesia (patient can feel touch, not cold), and 2 = anesthesia (patient cannot feel touch)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>motor block onset time</measure>
    <time_frame>before surgery</time_frame>
    <description>blockage was evaluated and graded; with elbow flexion, thumb abduction, thumb opposition, thumb adduction for musculocutaneous, radial, median, ulnar nerves respectively. Motor blockage graduation was also according to a (validated) 3-point scale: 0 = no block, 1 = paresis and 2 = paralysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Ultrasound</condition>
  <condition>Nerve Block</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>USG guided infraclavicular block with single operator jedi grip technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>USG guided infraclavicular block with conventional double operator technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>USG guided infraclavicular block</intervention_name>
    <description>USG guided infraclavicular block was applied to patients either by conventional two-person technique or by one person Jedi technique according to the allocated group. On Group I single operator controlled the probe with one hand while controlling the needle and the syringe on the other hand with the Jedi technique. The needle was held between the index finger and the middle phalanx of the middle finger, and the syringe was held with fingers 4 and 5, with the plunger part to the thumb in the palm. On Group II, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic.</description>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group I</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing elective hand, wrist and forearm surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hepatic or renal failure&#xD;
&#xD;
          -  serious cardiac or pulmoner disease&#xD;
&#xD;
          -  local or systemic infection&#xD;
&#xD;
          -  sepsis&#xD;
&#xD;
          -  coagulation disorder&#xD;
&#xD;
          -  neurological, muscular or psychiatric disease&#xD;
&#xD;
          -  body mass index (BMI) below 18.5 or above 35&#xD;
&#xD;
          -  drug and substance abuse&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  refusal of regional anesthesia&#xD;
&#xD;
          -  history of allergy to local anesthetics&#xD;
&#xD;
          -  mental-motor retardation (inability to consent or assess the visual analog scale(VAS)&#xD;
             pain score)&#xD;
&#xD;
          -  preoperative long-term NSAIDs or opioid use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 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>assistant professor</investigator_title>
  </responsible_party>
  <keyword>Jedi Grip</keyword>
  <keyword>Ultrasound guided infraclavicular block</keyword>
  <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/NCT04471025
org study id: E-18-1935
nct id: NCT04471025
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aimed to compare the block characteristics of the single operator "jedi
      grip" technique and the conventional double operator technique.
Patients undergoing hand, wrist, elbow and forearm surgery randomly assigned two groups
      (Group I: Jedi grip and Group II: Conventional double operator technique). By a blind
      observer, the block characteristics were evaluated and recorded .
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: single-center, prospective, randomized into two goups: Jedi grip versus conventional double operator technique
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: After completion of the block, a single blinded observer recorded demographic data and evaluated the block characteristics
measure: block performance time
time frame: during block application
description: teh sum of imaging and needling time
measure: block success
time frame: during surgery
description: incidence of ( %) surgery with successful anesthesia
measure: Sensory block onset time
time frame: before surgery
description: Sensory blockage was evaluated and graded; from lateral to the forearm, the volar face of the thumb, volar face of the 5th finger and lateral side of the hand back; for musculocutaneous, median, ulnar and radial nerves, respectively. Graduation was according to a previously validated 3-point scale using a cold test: 0 = no block, 1 = analgesia (patient can feel touch, not cold), and 2 = anesthesia (patient cannot feel touch)
measure: motor block onset time
time frame: before surgery
description: blockage was evaluated and graded; with elbow flexion, thumb abduction, thumb opposition, thumb adduction for musculocutaneous, radial, median, ulnar nerves respectively. Motor blockage graduation was also according to a (validated) 3-point scale: 0 = no block, 1 = paresis and 2 = paralysis.
arm group label: Group I
arm group type: Active Comparator
description: USG guided infraclavicular block with single operator jedi grip technique
arm group label: Group 2
arm group type: Active Comparator
description: USG guided infraclavicular block with conventional double operator technique
intervention type: Procedure
intervention name: USG guided infraclavicular block
description: USG guided infraclavicular block was applied to patients either by conventional two-person technique or by one person Jedi technique according to the allocated group. On Group I single operator controlled the probe with one hand while controlling the needle and the syringe on the other hand with the Jedi technique. The needle was held between the index finger and the middle phalanx of the middle finger, and the syringe was held with fingers 4 and 5, with the plunger part to the thumb in the palm. On Group II, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic.
arm group label: Group 2
arm group label: Group I
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 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
responsible party type: Principal Investigator
investigator affiliation: Ankara City Hospital Bilkent
investigator full name: ismail aytaç
investigator title: assistant professor
sharing ipd: No