<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/NCT03825172</url>
  </required_header>
  <id_info>
    <org_study_id>72109855-604.01.01-103424</org_study_id>
    <nct_id>NCT03825172</nct_id>
  </id_info>
  <brief_title>Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients</brief_title>
  <official_title>Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pinar Kendigelen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ayse Cigdem Tutuncu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaya, Guner, M.D.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Detailed study of ultrasonographic caudal epidural anatomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Caudal epidural block is one of the most common methods to provide analgesia for an&#xD;
      infraumbilical surgery in children. Although it can be carried out safely and easily, many&#xD;
      complications have been described so far, because of inaccurate needle injections. To perform&#xD;
      a successful block, a good caudal epidural anatomic assessment is essential. Ultrasonography&#xD;
      is an important tool to perform pediatric regional blocks, including caudal blocks. We&#xD;
      believe that caudal epidural ultrasound evaluation can be an important option to decrease&#xD;
      complications and to achieve a successful attempt; due to that we will try to describe caudal&#xD;
      epidural ultrasound imaging and changes from one month to 84 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">January 20, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Definition Of Dural Sac Termination Level By Ultrasonography</measure>
    <time_frame>5 minutes</time_frame>
    <description>After general anesthesia, patient will be placed in lateral decubitus position. First, a 12 MHz lineer ultrasound transducer will be placed transversely to obtain the transverse view of sacral hiatus; in this view we will try to show two sacral cornua, sacrococcygeal ligament, posterior sacral bone and caudal epidural depth. Secondly, transducer will be turned parallel to the midline or paravertebral to obtain longitudinal view; in longitudinal view we will try to obtain the images of sacral vertebral corpuses, caudal epidural area and dural sac. We will try to determine the level of dural sac termination according to a part of vertabral corpus or an intervertebral distance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle</measure>
    <time_frame>5 minutes</time_frame>
    <description>Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle will be measured under longitudinal ultrasound view</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Definition Of Average Caudal Epidural Depth By Ultrasonography</measure>
    <time_frame>5 minutes</time_frame>
    <description>Definition of caudal epidural depth by ultrasonography will be obtained under transverse view for every patient and average value will be defined for every age group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination Of Sacral Cornua As An Anatomic Landmark And Confirmation By Ultrasonography</measure>
    <time_frame>5 minutes</time_frame>
    <description>Sacral cornua will be palpated and than will be scanned under transverse ultrasound view. Also results will be compared.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">348</enrollment>
  <condition>Anesthesia, Caudal</condition>
  <condition>Anatomy</condition>
  <condition>Ultrasonography</condition>
  <condition>Pediatrics</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <description>Caudal Epidural Ultrasonography will be performed in patients aged between 1-24 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <description>Caudal Epidural Ultrasonography will be performed in patients aged between 25-48 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III</arm_group_label>
    <description>Caudal Epidural Ultrasonography will be performed in patients aged between 49-84 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Caudal Epidural Ultrasonography</intervention_name>
    <description>Ultrasonographic Measurement</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_label>Group III</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients who are admitted to operating room for any pediatric surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients who applied for any pediatric surgery from 20 january to 20 july&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Premature patients&#xD;
&#xD;
          -  Patients who have any sendromic diagnosis&#xD;
&#xD;
          -  Patients who have any musculoskeletal abnormalities&#xD;
&#xD;
          -  Patients who have any spinal abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>84 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celal Kaya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cerrahpasa Medical Faculty</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>December 22, 2021</last_update_submitted>
  <last_update_submitted_qc>December 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Celal Kaya</investigator_full_name>
    <investigator_title>resident</investigator_title>
  </responsible_party>
  <keyword>Caudal block</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Children</keyword>
  <keyword>Regional block anatomy</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03825172
org study id: 72109855-604.01.01-103424
nct id: NCT03825172
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Detailed study of ultrasonographic caudal epidural anatomy
Caudal epidural block is one of the most common methods to provide analgesia for an
      infraumbilical surgery in children. Although it can be carried out safely and easily, many
      complications have been described so far, because of inaccurate needle injections. To perform
      a successful block, a good caudal epidural anatomic assessment is essential. Ultrasonography
      is an important tool to perform pediatric regional blocks, including caudal blocks. We
      believe that caudal epidural ultrasound evaluation can be an important option to decrease
      complications and to achieve a successful attempt; due to that we will try to describe caudal
      epidural ultrasound imaging and changes from one month to 84 months.
observational model: Case-Only
time perspective: Prospective
measure: Definition Of Dural Sac Termination Level By Ultrasonography
time frame: 5 minutes
description: After general anesthesia, patient will be placed in lateral decubitus position. First, a 12 MHz lineer ultrasound transducer will be placed transversely to obtain the transverse view of sacral hiatus; in this view we will try to show two sacral cornua, sacrococcygeal ligament, posterior sacral bone and caudal epidural depth. Secondly, transducer will be turned parallel to the midline or paravertebral to obtain longitudinal view; in longitudinal view we will try to obtain the images of sacral vertebral corpuses, caudal epidural area and dural sac. We will try to determine the level of dural sac termination according to a part of vertabral corpus or an intervertebral distance.
measure: Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle
time frame: 5 minutes
description: Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle will be measured under longitudinal ultrasound view
measure: Definition Of Average Caudal Epidural Depth By Ultrasonography
time frame: 5 minutes
description: Definition of caudal epidural depth by ultrasonography will be obtained under transverse view for every patient and average value will be defined for every age group.
measure: Determination Of Sacral Cornua As An Anatomic Landmark And Confirmation By Ultrasonography
time frame: 5 minutes
description: Sacral cornua will be palpated and than will be scanned under transverse ultrasound view. Also results will be compared.
arm group label: Group I
description: Caudal Epidural Ultrasonography will be performed in patients aged between 1-24 months
arm group label: Group II
description: Caudal Epidural Ultrasonography will be performed in patients aged between 25-48 months
arm group label: Group III
description: Caudal Epidural Ultrasonography will be performed in patients aged between 49-84 months
intervention type: Diagnostic Test
intervention name: Caudal Epidural Ultrasonography
description: Ultrasonographic Measurement
arm group label: Group I
arm group label: Group II
arm group label: Group III
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 84 Months
healthy volunteers: No
last name: Celal Kaya, MD
role: Principal Investigator
affiliation: Istanbul University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Celal Kaya
investigator title: resident
sharing ipd: Undecided