<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/NCT01690156</url>
  </required_header>
  <id_info>
    <org_study_id>Probeposition</org_study_id>
    <nct_id>NCT01690156</nct_id>
  </id_info>
  <brief_title>Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks</brief_title>
  <official_title>Double Blinded Randomized Control Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ultrasound has been used to guide a needle to inject local anesthetics around nerves. This is&#xD;
      usually done in the same plane as the ultrasound beam in America and is known as an in-plane&#xD;
      technique. When done correctly, the entire needle is visualized on the ultrasound screen as&#xD;
      it approaches the nerves which are also seen on the same screen the entire time. The&#xD;
      ultrasound probe can be held perpendicular or parallel to the shoulders of the person&#xD;
      performing the in-plane technique. Our hypothesis is that holding the ultrasound probe&#xD;
      perpendicular to the shoulder is superior to holding the probe parallel to the shoulder&#xD;
      during an in-plane ultrasound guided regional anesthesia technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Right handed volunteers with no prior exposure to ultrasound techniques are used in this&#xD;
      study. They will be randomly assigned to be shown an instructional video on how to perform an&#xD;
      in-plane ultrasound guided needling technique on a realistic simulation target. The two&#xD;
      videos are identical with the exception of the probe position. A blinded assessor will time&#xD;
      the volunteers performance behind a screen and note the duration in which the needle is not&#xD;
      visualized in the ultrasound screen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time taken to perform a simulated interscalene block</measure>
    <time_frame>1 hour</time_frame>
    <description>Time taken to perform a simulated interscalene block after watching an instructional video on ultrasound guided regional anesthesia on the simulated targets</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration where the entire needle is not visualized when performing the simulated interscalene block</measure>
    <time_frame>1 hour</time_frame>
    <description>Time taken to perform a simulated interscalene block after watching an instructional video on ultrasound guided regional anesthesia on the simulated targets</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>In-plane Ultrasound-guided Regional Anesthesia Performance</condition>
  <arm_group>
    <arm_group_label>Parallel Probe Position</arm_group_label>
    <description>Performing the simulated interscalene block with the ultrasound probe parallel to the shoulders of the person performing the block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Perpendicular Probe Position</arm_group_label>
    <description>Performing the simulated interscalene block with the ultrasound probe perpendicular to the shoulders of the person performing the block</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers naiive to ultrasound techniques&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  Right handed&#xD;
&#xD;
          -  Aged 18 to 55&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any person who has prior knowledge about ultrasound imaging or regional anesthesia&#xD;
&#xD;
          -  Any person who has prior experience with laparoscopy or biopsy&#xD;
&#xD;
          -  Any person who has problems with depth of field or simple hand eye co-ordination task&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas C Lam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>In-plane</keyword>
  <keyword>Ultrasound-guided regional anesthesia performance</keyword>
  <keyword>Probe position</keyword>
  <keyword>Needle visualization</keyword>
  <!-- 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/NCT01690156
org study id: Probeposition
nct id: NCT01690156
lead sponsor: 
has dmc: No
Ultrasound has been used to guide a needle to inject local anesthetics around nerves. This is
      usually done in the same plane as the ultrasound beam in America and is known as an in-plane
      technique. When done correctly, the entire needle is visualized on the ultrasound screen as
      it approaches the nerves which are also seen on the same screen the entire time. The
      ultrasound probe can be held perpendicular or parallel to the shoulders of the person
      performing the in-plane technique. Our hypothesis is that holding the ultrasound probe
      perpendicular to the shoulder is superior to holding the probe parallel to the shoulder
      during an in-plane ultrasound guided regional anesthesia technique.
Right handed volunteers with no prior exposure to ultrasound techniques are used in this
      study. They will be randomly assigned to be shown an instructional video on how to perform an
      in-plane ultrasound guided needling technique on a realistic simulation target. The two
      videos are identical with the exception of the probe position. A blinded assessor will time
      the volunteers performance behind a screen and note the duration in which the needle is not
      visualized in the ultrasound screen.
observational model: Case-Control
time perspective: Prospective
measure: Time taken to perform a simulated interscalene block
time frame: 1 hour
description: Time taken to perform a simulated interscalene block after watching an instructional video on ultrasound guided regional anesthesia on the simulated targets
measure: Duration where the entire needle is not visualized when performing the simulated interscalene block
time frame: 1 hour
description: Time taken to perform a simulated interscalene block after watching an instructional video on ultrasound guided regional anesthesia on the simulated targets
arm group label: Parallel Probe Position
description: Performing the simulated interscalene block with the ultrasound probe parallel to the shoulders of the person performing the block
arm group label: Perpendicular Probe Position
description: Performing the simulated interscalene block with the ultrasound probe perpendicular to the shoulders of the person performing the block
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nicholas C Lam, MD
role: Principal Investigator
affiliation: University of New Mexico
facility: 
country: United States
responsible party type: Sponsor