<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/NCT02982031</url>
  </required_header>
  <id_info>
    <org_study_id>302/2559(EC4)</org_study_id>
    <nct_id>NCT02982031</nct_id>
  </id_info>
  <brief_title>A Comparison of Visualization Between Shamrock Technique and Paramedian Transverse Scan in Lumbar Plexus Blockade</brief_title>
  <official_title>A Comparison of Visualization Between Shamrock Technique and Paramedian Transverse Scan in Lumbar Plexus Blockade</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study was to compare ultrasound visibility of the lumbar plexus&#xD;
      at the intertransverse space between paramedian transverse scan and shamrock technique.&#xD;
      Moreover obtaining a clear image of relevant structures is imperative. Thus, the secondary&#xD;
      objective was to assess ultrasound visibility of each relevant structure and overall&#xD;
      visibility between these two methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Ultrasound-guided lumbar plexus block (USG LPB) is regarded as a form of advanced&#xD;
      ultrasound-guided regional anesthesia (USGRA). One of the key challenges of USG LPB is&#xD;
      visualization of the lumbar plexus. That are currently in use for ultrasound-guided lumbar&#xD;
      plexus blockade - paramedian transverse scan (PMTS) and shamrock technique.&#xD;
&#xD;
      Method: Twenty-three healthy adult volunteers aged ≥ 18 years were enrolled in this&#xD;
      prospective cohort study. Ultrasound visualization results were compared between methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Video (VDO) loops visualization of lumbar plexus</measure>
    <time_frame>1 month</time_frame>
    <description>Percentage of Video (VDO) loops visualization of lumbar plexus comparing between two techniques</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasound visibility score of each relevant structures</measure>
    <time_frame>1 month</time_frame>
    <description>10 structures: Erector spinae muscle, Quadratus lumborum muscle, Psoas muscle, Vertebral body, Inferior vena cava, Articular process of the lumbar vertebra, Lumbar paravertebral space, lumbar nerve root, Lumbar plexus nerve, Psoas compartment Using 4-point Likert scale (0, not visible; 1, hardly visible; 2, well visible; 3, very well visible)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall ultrasound visibility score of 10 structures</measure>
    <time_frame>1 month</time_frame>
    <description>Sum of ultrasound visibility score of 10 relevant structures: Erector spinae muscle, Quadratus lumborum muscle, Psoas muscle, Vertebral body, Inferior vena cava, Articular process of the lumbar vertebra, Lumbar paravertebral space, lumbar nerve root, Lumbar plexus nerve, Psoas compartment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Lumbar Plexus Blockade</condition>
  <arm_group>
    <arm_group_label>shamrock</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>shamrock: both left and right sided scan,both intertransverse and transverse process window</description>
  </arm_group>
  <arm_group>
    <arm_group_label>paramedian transverse scan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>paramedian transverse scan (PMTS): both left and right, both intertransverse and transverse process window</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>shamrock</intervention_name>
    <description>This scanning technique is performed in the lateral decubitus position with the side of interest facing upwards. The transducer is placed in the transverse plane on the flank of the patient cranially to the iliac crest. The quadratus lumborum muscle is identified medial to the aponeurosis of the transversus abdominis muscle. With the psoas muscle anterior to the transverse process, the erector spinae muscle posterior to the transverse process, and the quadratus lumborum muscle attached to the apex of the transverse process of L4.</description>
    <arm_group_label>shamrock</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>paramedian transverse scan</intervention_name>
    <description>The ultrasound transducer is positioned 4 cm lateral to the midline along the intercristal line and just above the iliac crest. The transducer is also directed slightly medially.</description>
    <arm_group_label>paramedian transverse scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteer, age &gt;/= 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  spinal deformity and history of previous back or spine surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pawinee Pawinee, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>66864001721</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siriraj hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ultrasound-guided lumbar plexus blockade</keyword>
  <keyword>Shamrock technique</keyword>
  <keyword>Paramedian transverse scan</keyword>
  <keyword>USG LPB</keyword>
  <keyword>USGRA</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/NCT02982031
org study id: 302/2559(EC4)
nct id: NCT02982031
lead sponsor: 
has dmc: Yes
The primary objective of this study was to compare ultrasound visibility of the lumbar plexus
      at the intertransverse space between paramedian transverse scan and shamrock technique.
      Moreover obtaining a clear image of relevant structures is imperative. Thus, the secondary
      objective was to assess ultrasound visibility of each relevant structure and overall
      visibility between these two methods.
Background: Ultrasound-guided lumbar plexus block (USG LPB) is regarded as a form of advanced
      ultrasound-guided regional anesthesia (USGRA). One of the key challenges of USG LPB is
      visualization of the lumbar plexus. That are currently in use for ultrasound-guided lumbar
      plexus blockade - paramedian transverse scan (PMTS) and shamrock technique.

      Method: Twenty-three healthy adult volunteers aged ≥ 18 years were enrolled in this
      prospective cohort study. Ultrasound visualization results were compared between methods.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Percentage of Video (VDO) loops visualization of lumbar plexus
time frame: 1 month
description: Percentage of Video (VDO) loops visualization of lumbar plexus comparing between two techniques
measure: Ultrasound visibility score of each relevant structures
time frame: 1 month
description: 10 structures: Erector spinae muscle, Quadratus lumborum muscle, Psoas muscle, Vertebral body, Inferior vena cava, Articular process of the lumbar vertebra, Lumbar paravertebral space, lumbar nerve root, Lumbar plexus nerve, Psoas compartment Using 4-point Likert scale (0, not visible; 1, hardly visible; 2, well visible; 3, very well visible)
measure: Overall ultrasound visibility score of 10 structures
time frame: 1 month
description: Sum of ultrasound visibility score of 10 relevant structures: Erector spinae muscle, Quadratus lumborum muscle, Psoas muscle, Vertebral body, Inferior vena cava, Articular process of the lumbar vertebra, Lumbar paravertebral space, lumbar nerve root, Lumbar plexus nerve, Psoas compartment
arm group label: shamrock
arm group type: Sham Comparator
description: shamrock: both left and right sided scan,both intertransverse and transverse process window
arm group label: paramedian transverse scan
arm group type: Active Comparator
description: paramedian transverse scan (PMTS): both left and right, both intertransverse and transverse process window
intervention type: Procedure
intervention name: shamrock
description: This scanning technique is performed in the lateral decubitus position with the side of interest facing upwards. The transducer is placed in the transverse plane on the flank of the patient cranially to the iliac crest. The quadratus lumborum muscle is identified medial to the aponeurosis of the transversus abdominis muscle. With the psoas muscle anterior to the transverse process, the erector spinae muscle posterior to the transverse process, and the quadratus lumborum muscle attached to the apex of the transverse process of L4.
arm group label: shamrock
intervention type: Procedure
intervention name: paramedian transverse scan
description: The ultrasound transducer is positioned 4 cm lateral to the midline along the intercristal line and just above the iliac crest. The transducer is also directed slightly medially.
arm group label: paramedian transverse scan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pawinee Pawinee, M.D
role: Principal Investigator
affiliation: 66864001721
facility: 
country: Thailand
responsible party type: Sponsor
sharing ipd: No