<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/NCT02990702</url>
  </required_header>
  <id_info>
    <org_study_id>31</org_study_id>
    <nct_id>NCT02990702</nct_id>
  </id_info>
  <brief_title>Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese Patients</brief_title>
  <official_title>Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kahramanmaras Sutcu Imam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kahramanmaras Sutcu Imam University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between&#xD;
      the needle and the ultrasound beam. Retroclavicular approach has already been proven&#xD;
      effective and safe in the past. The general objective is to provide a formal comparison&#xD;
      between the retroclavicular approach and coracoid infraclavicular approach for brachial&#xD;
      plexus anaesthesia. This study should represent the differences between the two techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Classic infraclavicular approach of the brachial plexus involves a needle puncture below the&#xD;
      clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. The aim&#xD;
      is to advanced the block needle posterior to the axillary artery and to deposit the local&#xD;
      anesthetic at that point, near the posterior cord. A &quot;U&quot; shaped spread around the artery&#xD;
      should ensure distribution around all three cords. Ultrasound guidance is highly recommended&#xD;
      and neurostimulation is optional.&#xD;
&#xD;
      The retroclavicular approach is a variant to this classical technique. Ultrasound probe is&#xD;
      positioned initially below the clavicle in a manner similar to the classic approach but is&#xD;
      then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for&#xD;
      about 25-35 degrees. The puncture site is just behind the clavicle at the most lateral point&#xD;
      available. If initial entry point is optimal, needle direction is then parallel to ultrasound&#xD;
      probe. The final aim and position of block needle is identical to classical approach. Entry&#xD;
      point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling&#xD;
      almost perfect visualization of both artery, cords and block needle. This is turn optimizes&#xD;
      safety, rapidity of technique, efficiency and efficacy.&#xD;
&#xD;
      It is recognized that regional anesthesia is more difficult to perform in obese patients.&#xD;
      Anatomic landmarks are harder to localize in this population and ultrasound guidance is more&#xD;
      difficult because of the attenuation of the ultrasound beam by adipose tissue. The&#xD;
      complication rate of regional techniques is also reported to be higher in the obese patient&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>Phase 4</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>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technique duration</measure>
    <time_frame>Measured directly during the procedure with a chronometer.</time_frame>
    <description>The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes. Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgery completion under regional block</measure>
    <time_frame>Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed</time_frame>
    <description>Success rate is defined as the completion of the intended surgery under regional anaesthesia with retroclavicular block without the need for a rescue technique.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensorial block progression</measure>
    <time_frame>Assessed 10, 20 and 30 minutes after block completion</time_frame>
    <description>Progress of the sensory block in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand at 10, 20 and 30 minutes after block completion. The scale used is: 0:no sensitive block, 1:analgesia (loss of pain but not tactile sensation), 2:anesthesia (loss of pain and tactile sensation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Block Progression</measure>
    <time_frame>Assessed 10, 20, 30 minutes after the block completion</time_frame>
    <description>Progress of the motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand at 10, 20, and 30 minutes after block completion. The scale used is: 0: no motor block, 1: paresis, 2: paralysis. No units are attached to this scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Needle visualization</measure>
    <time_frame>Assessed one week after study completion</time_frame>
    <description>Procedures will be recorded and reviewed simultaneously after study completion by 2 independent anesthesiologists skilled in US-guided regional anesthesia using a 5-point Likert scale to rate needle visibility (1=very poor,2=poor,3=fair,4=good,5=very good)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Forearm Injuries</condition>
  <condition>Hand Injuries</condition>
  <arm_group>
    <arm_group_label>Ultrasound guided retroclavicular block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound guided infraclavicular block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound guided retroclavicular block</intervention_name>
    <description>Ultrasound guided retroclavicular block for forearm or hand surgery</description>
    <arm_group_label>Ultrasound guided infraclavicular block</arm_group_label>
    <arm_group_label>Ultrasound guided retroclavicular block</arm_group_label>
    <other_name>Group R</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound guided coracoid infraclavicular block</intervention_name>
    <description>Ultrasound guided infraclavicular block for forearm or hand surgery</description>
    <arm_group_label>Ultrasound guided infraclavicular block</arm_group_label>
    <arm_group_label>Ultrasound guided retroclavicular block</arm_group_label>
    <other_name>Group C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <arm_group_label>Ultrasound guided infraclavicular block</arm_group_label>
    <arm_group_label>Ultrasound guided retroclavicular block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <arm_group_label>Ultrasound guided infraclavicular block</arm_group_label>
    <arm_group_label>Ultrasound guided retroclavicular block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-80 years&#xD;
&#xD;
          -  BMI&gt;30&#xD;
&#xD;
          -  Forearm- Hand surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years&#xD;
&#xD;
          -  Local infection&#xD;
&#xD;
          -  Coagulopaty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kahramanmaras Sutcu Imam University</investigator_affiliation>
    <investigator_full_name>Bora Bilal</investigator_full_name>
    <investigator_title>Assistant Proffesor</investigator_title>
  </responsible_party>
  <keyword>Infraclavicular block</keyword>
  <keyword>Retroclavicular block</keyword>
  <keyword>Ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Hand Injuries</mesh_term>
    <mesh_term>Forearm Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_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/NCT02990702
org study id: 31
nct id: NCT02990702
lead sponsor: 
has dmc: No
The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between
      the needle and the ultrasound beam. Retroclavicular approach has already been proven
      effective and safe in the past. The general objective is to provide a formal comparison
      between the retroclavicular approach and coracoid infraclavicular approach for brachial
      plexus anaesthesia. This study should represent the differences between the two techniques.
Classic infraclavicular approach of the brachial plexus involves a needle puncture below the
      clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. The aim
      is to advanced the block needle posterior to the axillary artery and to deposit the local
      anesthetic at that point, near the posterior cord. A "U" shaped spread around the artery
      should ensure distribution around all three cords. Ultrasound guidance is highly recommended
      and neurostimulation is optional.

      The retroclavicular approach is a variant to this classical technique. Ultrasound probe is
      positioned initially below the clavicle in a manner similar to the classic approach but is
      then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for
      about 25-35 degrees. The puncture site is just behind the clavicle at the most lateral point
      available. If initial entry point is optimal, needle direction is then parallel to ultrasound
      probe. The final aim and position of block needle is identical to classical approach. Entry
      point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling
      almost perfect visualization of both artery, cords and block needle. This is turn optimizes
      safety, rapidity of technique, efficiency and efficacy.

      It is recognized that regional anesthesia is more difficult to perform in obese patients.
      Anatomic landmarks are harder to localize in this population and ultrasound guidance is more
      difficult because of the attenuation of the ultrasound beam by adipose tissue. The
      complication rate of regional techniques is also reported to be higher in the obese patient
      population.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Investigator, Outcomes Assessor)
measure: Technique duration
time frame: Measured directly during the procedure with a chronometer.
description: The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes. Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach.
measure: Surgery completion under regional block
time frame: Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed
description: Success rate is defined as the completion of the intended surgery under regional anaesthesia with retroclavicular block without the need for a rescue technique.
measure: Sensorial block progression
time frame: Assessed 10, 20 and 30 minutes after block completion
description: Progress of the sensory block in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand at 10, 20 and 30 minutes after block completion. The scale used is: 0:no sensitive block, 1:analgesia (loss of pain but not tactile sensation), 2:anesthesia (loss of pain and tactile sensation).
measure: Motor Block Progression
time frame: Assessed 10, 20, 30 minutes after the block completion
description: Progress of the motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand at 10, 20, and 30 minutes after block completion. The scale used is: 0: no motor block, 1: paresis, 2: paralysis. No units are attached to this scale.
measure: Needle visualization
time frame: Assessed one week after study completion
description: Procedures will be recorded and reviewed simultaneously after study completion by 2 independent anesthesiologists skilled in US-guided regional anesthesia using a 5-point Likert scale to rate needle visibility (1=very poor,2=poor,3=fair,4=good,5=very good)
arm group label: Ultrasound guided retroclavicular block
arm group type: Active Comparator
description: Ultrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine
arm group label: Ultrasound guided infraclavicular block
arm group type: Active Comparator
description: Ultrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine
intervention type: Other
intervention name: Ultrasound guided retroclavicular block
description: Ultrasound guided retroclavicular block for forearm or hand surgery
arm group label: Ultrasound guided infraclavicular block
arm group label: Ultrasound guided retroclavicular block
other name: Group R
intervention type: Other
intervention name: Ultrasound guided coracoid infraclavicular block
description: Ultrasound guided infraclavicular block for forearm or hand surgery
arm group label: Ultrasound guided infraclavicular block
arm group label: Ultrasound guided retroclavicular block
other name: Group C
intervention type: Drug
intervention name: Bupivacaine
arm group label: Ultrasound guided infraclavicular block
arm group label: Ultrasound guided retroclavicular block
intervention type: Device
intervention name: Ultrasound
arm group label: Ultrasound guided infraclavicular block
arm group label: Ultrasound guided retroclavicular block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Kahramanmaras Sutcu Imam University
investigator full name: Bora Bilal
investigator title: Assistant Proffesor
mesh term: Wounds and Injuries
mesh term: Hand Injuries
mesh term: Forearm Injuries
mesh term: Bupivacaine
sharing ipd: No