<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/NCT01686243</url>
  </required_header>
  <id_info>
    <org_study_id>12-560</org_study_id>
    <nct_id>NCT01686243</nct_id>
  </id_info>
  <brief_title>Real-time Ultrasound-guided Paramedian Epidural Access: Evaluation of a Novel In-plane Transverse View Technique</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to demonstrate the feasibility of a new technique using real time&#xD;
      ultrasound guided paramedian approach to the epidural space. This approach will use&#xD;
      transverse view of the spine utilizing curvilinear low frequency ultrasound probe &quot;Sonosite S&#xD;
      nerve&quot; and echogenic 17G tuohy needles &quot; Pajunk TuohySono&quot;&#xD;
&#xD;
      The investigators believe that this new technique is helpful to get the best anatomic&#xD;
      landmark for epidural catheter placement using the real-time ultrasound.&#xD;
&#xD;
      Measurable outcomes:&#xD;
&#xD;
        -  Block performance time.&#xD;
&#xD;
        -  Block success rate.&#xD;
&#xD;
        -  Needle Depth to epidural space&#xD;
&#xD;
      Block success rate will be measured as the rate of cases that will have successful insertion&#xD;
      of the epidural catheter using ultrasound guidance and the case is done completely under&#xD;
      epidural anesthesia.&#xD;
&#xD;
      All cases that will be converted to general anesthesia will be counted unsuccessful.&#xD;
&#xD;
      Other measurable outcome data that will be collected will include needle depth to the&#xD;
      epidural space, and ultrasound measured depth to the lamina&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">November 25, 2016</completion_date>
  <primary_completion_date type="Actual">November 25, 2016</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Real-time ultrasound-guided paramedian epidural access:</measure>
    <time_frame>Day 1</time_frame>
    <description>Block success rate will be measured as the rate of cases that will have succesful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia. The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe &quot;Sonosite S nerve&quot; and echogenic 17G tuohy needles &quot; Pajunk TuohySono&quot;</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Epidural Placement</condition>
  <arm_group>
    <arm_group_label>echogenic 17G tuohy needles &quot; Pajunk TuohySono</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Epidural will be placed with the aid of ultrasound and echogenic 17G Tuohy needles (Pajunk TuohySono).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard epidural needles</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Epidural will be placed in standard practice with standard needles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)</intervention_name>
    <description>Anesthesiologist will place epidural with aid of ultrasound and placement with echogenic 17G Tuohy needles (Pajunk TuohySono)</description>
    <arm_group_label>echogenic 17G tuohy needles &quot; Pajunk TuohySono</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard epidural placement</intervention_name>
    <description>Anesthesiologist will place epidural within standard practice, with standard needles.</description>
    <arm_group_label>standard epidural needles</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult Patients 30 to 80 years old at time of surgery.&#xD;
&#xD;
          -  Patients in whom epidural anesthesia is planned to be used as the for surgery &quot;&#xD;
             Surgical epidural&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or recent drug abuse (within past 6 months).&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Patient refusal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherif Zaky, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>April 4, 2019</last_update_submitted>
  <last_update_submitted_qc>April 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Loran Mounir Solimin, MD</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>epidural</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/NCT01686243
org study id: 12-560
nct id: NCT01686243
lead sponsor: 
has dmc: No
The aim of this study is to demonstrate the feasibility of a new technique using real time
      ultrasound guided paramedian approach to the epidural space. This approach will use
      transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S
      nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"

      The investigators believe that this new technique is helpful to get the best anatomic
      landmark for epidural catheter placement using the real-time ultrasound.

      Measurable outcomes:

        -  Block performance time.

        -  Block success rate.

        -  Needle Depth to epidural space

      Block success rate will be measured as the rate of cases that will have successful insertion
      of the epidural catheter using ultrasound guidance and the case is done completely under
      epidural anesthesia.

      All cases that will be converted to general anesthesia will be counted unsuccessful.

      Other measurable outcome data that will be collected will include needle depth to the
      epidural space, and ultrasound measured depth to the lamina
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Real-time ultrasound-guided paramedian epidural access:
time frame: Day 1
description: Block success rate will be measured as the rate of cases that will have succesful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia. The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"
arm group label: echogenic 17G tuohy needles " Pajunk TuohySono
arm group type: Experimental
description: Epidural will be placed with the aid of ultrasound and echogenic 17G Tuohy needles (Pajunk TuohySono).
arm group label: standard epidural needles
arm group type: Placebo Comparator
description: Epidural will be placed in standard practice with standard needles.
intervention type: Other
intervention name: epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)
description: Anesthesiologist will place epidural with aid of ultrasound and placement with echogenic 17G Tuohy needles (Pajunk TuohySono)
arm group label: echogenic 17G tuohy needles " Pajunk TuohySono
intervention type: Other
intervention name: standard epidural placement
description: Anesthesiologist will place epidural within standard practice, with standard needles.
arm group label: standard epidural needles
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sherif Zaky, M.D.
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Loran Mounir Solimin, MD
investigator title: M.D.