<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/NCT04463329</url>
  </required_header>
  <id_info>
    <org_study_id>E-18-1955</org_study_id>
    <nct_id>NCT04463329</nct_id>
  </id_info>
  <brief_title>Jedi Grip vs. Double Operator Technique for Axillary Brachial Plexus Block</brief_title>
  <official_title>Is Jedi Grip Efficient And Effective In Ultrasound Guided Peripheral Nerve Block: A Prospective, Randomized, Observer-Blinded Comparison Between Single And 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>
      In this prospective randomized controlled observer-blinded study we aimed to compare the&#xD;
      efficacy of a single operator technique so called Jedi Grip and conventional technique&#xD;
      requiring double operator in ultrasound guided axillary brachial plexus block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients aged between 18 and 65 years, American Society of Anesthesiologists (ASA) physical&#xD;
      status I to II ) undergoing elective hand, wrist and forearm surgery were prospectively&#xD;
      enrolled. Patients were randomly assigned to Group C (conventional technique) or group J&#xD;
      (Jedi technique). In both groups, axillary plexus blockage was provided by applying 5cc of a&#xD;
      mixture of 10 cc 0.5% bupivacaine and 10 cc 2% prilocaine to the ulnar, radial, median and&#xD;
      musculocutaneous nerves. Parameters such as performance time and the number of needle passes&#xD;
      were recorded during procedure. Subsequently, a blinded observer evaluated and recorded&#xD;
      parameters related to the success of blockage. The main outcome variable was performance time&#xD;
      and success rate (surgical anesthesia).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 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>the patients were randomly allocated to one of the two groups as Group C (conventional two-operator axillary brachial plexus blockage) and Group J (axillary brachial plexus block with single operator using Jedi grip)</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>After completion of the block, a blinded observer recorded demographic data and questioned the patients for felt pain related to the block procedure using a 10-cm visual analog scale (0 cm = no pain, 10 cm = worst imaginable pain). Patients were also questioned for symptoms related to the local anesthetic toxicity.&#xD;
Subsequently, measurements of brachial plexus blockade were carried out every 5 mins until 30 mins by the same blinded observer.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>block performance time</measure>
    <time_frame>during procedure</time_frame>
    <description>the sum of imaging and needling times</description>
  </primary_outcome>
  <primary_outcome>
    <measure>success rate</measure>
    <time_frame>during operation</time_frame>
    <description>patients percentage with provided successful anesthesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Onset time of sensory block</measure>
    <time_frame>before operation</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 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>Onset time of motor block</measure>
    <time_frame>before operation</time_frame>
    <description>Motor 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 3-point scale: 0 = no block, 1 = paresis and 2 = paralysis.[</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Brachial Plexus Block</condition>
  <condition>Ultrasound, Interventional</condition>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional two-operator axillary brachial plexus blockage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group J</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>axillary brachial plexus block with single operator using Jedi grip</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage</intervention_name>
    <description>on goup C, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic. On Group J 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.</description>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group J</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, serious cardiac or pulmoner disease, local or systemic&#xD;
             infection, sepsis, coagulation disorder, neurological, muscular or psychiatric&#xD;
             disease, body mass index (BMI) below 18.5 or above 35, drug and substance abuse,&#xD;
             pregnancy, refusal of regional anesthesia, history of allergy to local anesthetics,&#xD;
             mental-motor retardation (inability to consent or assess the visual analog scale(VAS)&#xD;
             pain score), preoperative long-term NSAIDs or opioid use and prior surgery in the&#xD;
             axillary regions.&#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 Bilkent</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 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 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>Brachial Plexus Block, Ultrasound-Guided, Jedi Grip, Double operator peripheric nerve 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/NCT04463329
org study id: E-18-1955
nct id: NCT04463329
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this prospective randomized controlled observer-blinded study we aimed to compare the
      efficacy of a single operator technique so called Jedi Grip and conventional technique
      requiring double operator in ultrasound guided axillary brachial plexus block.
Patients aged between 18 and 65 years, American Society of Anesthesiologists (ASA) physical
      status I to II ) undergoing elective hand, wrist and forearm surgery were prospectively
      enrolled. Patients were randomly assigned to Group C (conventional technique) or group J
      (Jedi technique). In both groups, axillary plexus blockage was provided by applying 5cc of a
      mixture of 10 cc 0.5% bupivacaine and 10 cc 2% prilocaine to the ulnar, radial, median and
      musculocutaneous nerves. Parameters such as performance time and the number of needle passes
      were recorded during procedure. Subsequently, a blinded observer evaluated and recorded
      parameters related to the success of blockage. The main outcome variable was performance time
      and success rate (surgical anesthesia).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: the patients were randomly allocated to one of the two groups as Group C (conventional two-operator axillary brachial plexus blockage) and Group J (axillary brachial plexus block with single operator using Jedi grip)
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: After completion of the block, a blinded observer recorded demographic data and questioned the patients for felt pain related to the block procedure using a 10-cm visual analog scale (0 cm = no pain, 10 cm = worst imaginable pain). Patients were also questioned for symptoms related to the local anesthetic toxicity.
Subsequently, measurements of brachial plexus blockade were carried out every 5 mins until 30 mins by the same blinded observer.
measure: block performance time
time frame: during procedure
description: the sum of imaging and needling times
measure: success rate
time frame: during operation
description: patients percentage with provided successful anesthesia
measure: Onset time of sensory block
time frame: before operation
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 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: Onset time of motor block
time frame: before operation
description: Motor 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 3-point scale: 0 = no block, 1 = paresis and 2 = paralysis.[
arm group label: Group C
arm group type: Active Comparator
description: conventional two-operator axillary brachial plexus blockage
arm group label: Group J
arm group type: Active Comparator
description: axillary brachial plexus block with single operator using Jedi grip
intervention type: Procedure
intervention name: conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage
description: on goup C, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic. On Group J 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.
arm group label: Group C
arm group label: Group J
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 Bilkent
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: Principal Investigator
sharing ipd: No