<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/NCT03805958</url>
  </required_header>
  <id_info>
    <org_study_id>30-2018-81</org_study_id>
    <nct_id>NCT03805958</nct_id>
  </id_info>
  <brief_title>Ultrasound-guided Combined Spinal-epidural Anesthesia: Pre-procedure Versus Real-time Scan</brief_title>
  <official_title>A Randomized Comparison of the Ultrasound-guided Combined Spinal-epidural Anesthesia Technique: Pre-procedure Scan Versus Real-time Scan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The investigators will compare the success rate, the consumed time, the number of needle&#xD;
      passing, the depth and angle of the needle, the anesthetic effect, complications, pain and&#xD;
      patient's satisfaction between 'Real-time scan' and 'Pre-procedure scan', when we performing&#xD;
      spinal/epidural combined anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traditionally, spinal/epidural combined anesthesia has been performed by palpation of the&#xD;
      landmark like Tuffier's line. There are some studies that using ultrasound improves the&#xD;
      success rate to regional anesthesia. There are two methods of using ultrasonography,&#xD;
      'Real-time scan' and 'Pre-procedure scan'. Direct comparison of these two methods is not yet&#xD;
      studied. So investigators will compare the success rate, the consumed time, the number of&#xD;
      needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain&#xD;
      and patient's satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 15, 2019</start_date>
  <completion_date type="Anticipated">January 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2020</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of needle pass</measure>
    <time_frame>intraoperative</time_frame>
    <description>Number of needle pass</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Regional Anesthesia Morbidity</condition>
  <condition>Ultrasonography</condition>
  <arm_group>
    <arm_group_label>Pre-procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Confirmed landmark by ultrasound scan before procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Real time</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Confirmed landmark by ultrasound scan during procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>realtime ultrasonography</intervention_name>
    <description>Applying realtime ultrasound during the combined anesthesia</description>
    <arm_group_label>Real time</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>prescan ultrasonography</intervention_name>
    <description>Applying realtime ultrasound before the combined anesthesia</description>
    <arm_group_label>Pre-procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spinal/Epidural combined anesthesia is required.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin infection or trauma&#xD;
&#xD;
          -  Abnormal coagulation lab&#xD;
&#xD;
          -  History of spine surgery&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Abnormal structure of spine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tae Kyong Kim, Kim</last_name>
    <role>Study Director</role>
    <affiliation>SMG-SNU Boramae hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tae Kyong Kim, MD, phD</last_name>
    <phone>+82-2-870-2519</phone>
    <email>ktkktk@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.</citation>
    <PMID>11172514</PMID>
  </reference>
  <reference>
    <citation>Kil HK, Cho JE, Kim WO, Koo BN, Han SW, Kim JY. Prepuncture ultrasound-measured distance: an accurate reflection of epidural depth in infants and small children. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):102-6. doi: 10.1016/j.rapm.2006.10.005.</citation>
    <PMID>17350519</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>September 20, 2019</last_update_submitted>
  <last_update_submitted_qc>September 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Tae Kyong Kim</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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/NCT03805958
org study id: 30-2018-81
nct id: NCT03805958
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators will compare the success rate, the consumed time, the number of needle
      passing, the depth and angle of the needle, the anesthetic effect, complications, pain and
      patient's satisfaction between 'Real-time scan' and 'Pre-procedure scan', when we performing
      spinal/epidural combined anesthesia.
Traditionally, spinal/epidural combined anesthesia has been performed by palpation of the
      landmark like Tuffier's line. There are some studies that using ultrasound improves the
      success rate to regional anesthesia. There are two methods of using ultrasonography,
      'Real-time scan' and 'Pre-procedure scan'. Direct comparison of these two methods is not yet
      studied. So investigators will compare the success rate, the consumed time, the number of
      needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain
      and patient's satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of needle pass
time frame: intraoperative
description: Number of needle pass
arm group label: Pre-procedure
arm group type: Experimental
description: Confirmed landmark by ultrasound scan before procedure
arm group label: Real time
arm group type: Active Comparator
description: Confirmed landmark by ultrasound scan during procedure
intervention type: Procedure
intervention name: realtime ultrasonography
description: Applying realtime ultrasound during the combined anesthesia
arm group label: Real time
intervention type: Procedure
intervention name: prescan ultrasonography
description: Applying realtime ultrasound before the combined anesthesia
arm group label: Pre-procedure
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Tae Kyong Kim, Kim
role: Study Director
affiliation: SMG-SNU Boramae hospital
last name: Tae Kyong Kim, MD, phD
phone: +82-2-870-2519
email: ktkktk@gmail.com
citation: Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.
PMID: 11172514
citation: Kil HK, Cho JE, Kim WO, Koo BN, Han SW, Kim JY. Prepuncture ultrasound-measured distance: an accurate reflection of epidural depth in infants and small children. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):102-6. doi: 10.1016/j.rapm.2006.10.005.
PMID: 17350519
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Tae Kyong Kim
investigator title: Assistant Professor
sharing ipd: No