<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/NCT03283865</url>
  </required_header>
  <id_info>
    <org_study_id>H-40844</org_study_id>
    <nct_id>NCT03283865</nct_id>
  </id_info>
  <brief_title>Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children</brief_title>
  <official_title>Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Caudal blocks are one of the most commonly performed regional anesthetics in children and are&#xD;
      performed daily for a host of infra-umbilical surgical procedures. A caudal block is an&#xD;
      epidural injection, most commonly of local anesthetic into the epidural space as accessed via&#xD;
      the sacral hiatus. In children, the sacral hiatus is a normally occurring aperture in which&#xD;
      the epidural space may be accessed with extremely minimal risk; as neural tissue ends more&#xD;
      proximally. Due to this measure of safety, caudal blocks are preferred in children when&#xD;
      compared with standard lumbar epidurals. Caudal blocks are performed blindly using palpation&#xD;
      and tactile feedback to assess if the medication is being administered in the correct&#xD;
      location. As a result of blind injection, administration of local anesthetic totally or&#xD;
      partially outside of the correct site can often be unnoticed or identified after a&#xD;
      significant volume has already been injected. With the potential for toxicity of local&#xD;
      anesthetic, this may result in either the inability to give a complete dose or an&#xD;
      unintentional and often unnoticed sham block &quot;incorrect site of injection&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Caudal blocks are one of the most commonly performed regional anesthetics in children and are&#xD;
      performed daily for a host of infra-umbilical surgical procedures. A caudal block is an&#xD;
      epidural injection, most commonly of local anesthetic into the epidural space as accessed via&#xD;
      the sacral hiatus. In children, the sacral hiatus is a normally occurring aperture in which&#xD;
      the epidural space may be accessed with extremely minimal risk; as neural tissue ends more&#xD;
      proximally. Due to this measure of safety, caudal blocks are preferred in children when&#xD;
      compared with standard lumbar epidurals. Caudal blocks are performed blindly using palpation&#xD;
      and tactile feedback to assess if the medication is being administered in the correct&#xD;
      location. As a result of blind injection, administration of local anesthetic totally or&#xD;
      partially outside of the correct site can often be unnoticed or identified after a&#xD;
      significant volume has already been injected. With the potential for toxicity of local&#xD;
      anesthetic, this may result in either the inability to give a complete dose or an&#xD;
      unintentional and often unnoticed sham block &quot;incorrect site of injection&quot;.&#xD;
&#xD;
      Use of ultrasound has been proposed for identification of caudal block placement and correct&#xD;
      medication spread. However, a recent review of the Pediatric Regional Anesthesia Network&#xD;
      database reveals that ultrasound is reportedly only used in less that 3% of blocks. The&#xD;
      benefit of ultrasound is safe and real-time confirmation of injection. Ultrasound allows the&#xD;
      provider to determine with minimal local anesthetic or even saline injection if the correct&#xD;
      space is accessed. Without ultrasound, failed blocks are either identified after significant&#xD;
      percentage of the total dose of local anesthetic is incorrectly administered or intra or post&#xD;
      operatively when the patient demonstrates a significant opioid requirement. This is&#xD;
      problematic given that one of the primary benefits of a caudal block in children is the&#xD;
      ability to avoid opioids.&#xD;
&#xD;
      Review of local practice here at Texas Children's Hospital for quality improvement purposes&#xD;
      revealed a failure rate of caudal blocks to be 18%. Failure was defined as a heart rate&#xD;
      increase with incision of &gt;20% despite a caudal block and &gt;1MAC of gas for the patient age.&#xD;
      These patients all required opioids both intra and post operatively in addition to surgical&#xD;
      levels of inhaled anesthetic agent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    doesnt meet criteria for clinical trial reporting&#xD;
  </why_stopped>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single blinded prospective trial in which all patients serve as their own clinical control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Single blinded prospective trial in which all patients serve as their own clinical control group.&#xD;
Provider doing the procedure will be blinded to intervention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Identify the rate at which blindly placed caudal blocks are not within the epidural space</measure>
    <time_frame>15 minutes</time_frame>
    <description>Assess the percentage of providers not recognizing wrong site of injection without ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identify the rate at which ultrasound can guide a wrong block into the correct location</measure>
    <time_frame>15 minutes</time_frame>
    <description>Assess the number of blocks that are require the use of ultrasound to redirect needle into caudal space</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify if lack of heart rate change on incision can predict successful placement when medication administration is successfully confirmed with ultrasound</measure>
    <time_frame>15 minutes</time_frame>
    <description>With ultrasound identification of correct caudal injection, (successful block), does lack of heart rate change correlated with successful block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify if after using ultrasound to visualize placement, if concentrations of inhaled agents may be reduced in children</measure>
    <time_frame>30 minutes to 3 hours</time_frame>
    <description>With demonstration of successful caudal injection, can inhaled agent concentration be reduced as calculated by MAC hours</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Regional Anesthesia Morbidity</condition>
  <arm_group>
    <arm_group_label>Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The attending anesthesiologist will perform or instruct the placement of a caudal block according to their standard of practice. At the time of administration of local anesthetic into the caudal space, the study collaborator (SC) will ultrasound the caudal space keeping the provider placing the block blinded to the imaging. The provider placing the block will inject 0.5mL of saline. The provider will then be asked to state if they are correctly in the caudal space or not. If the provider feels they are not in the caudal space, they will re-do the procedure. If the provider fails to identify incorrect location and this is noted by ultrasound, the SC will inform the provider to re-do the procedure.&#xD;
All study participants will have ultrasound used for caudal block.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound guidance for caudal block</intervention_name>
    <description>The attending anesthesiologist will perform or instruct the placement of a caudal block according to their standard of practice. At the time of administration of local anesthetic into the caudal space, the study collaborator (SC) will ultrasound the caudal space keeping the provider placing the block blinded to the imaging. The provider placing the block will inject 0.5mL of preservative free saline. The provider will then be asked to state if they are correctly in the caudal space or not. If the provider feels they are not in the caudal space, they will re-do the procedure. If the provider fails to identify incorrect location and this is noted by ultrasound, the SC will inform the provider to re-do the procedure</description>
    <arm_group_label>Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children ages 0-84 months&#xD;
&#xD;
          -  Infra-umbilical procedure for which a caudal block is already planned&#xD;
&#xD;
          -  American Society of Anesthesiology classifications of 1,2 or 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incarcerated hernias&#xD;
&#xD;
          -  Emergency procedures&#xD;
&#xD;
          -  Local Anesthetic allergy&#xD;
&#xD;
          -  Sacral dimple&#xD;
&#xD;
          -  Rash over sacrum&#xD;
&#xD;
          -  Parents/legal guardians unable to consent for surgical procedure in English language&#xD;
             Foster Care/Child protective services as guardians&#xD;
&#xD;
          -  Parental Refusal for caudal block or study participation&#xD;
&#xD;
          -  American Society of Anesthesiology classifications other than 1,2 or 3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam C Adler, MD, FAAP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Childrens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas childrens Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Adam Adler MD, MS, FAAP</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03283865/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03283865
org study id: H-40844
nct id: NCT03283865
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Caudal blocks are one of the most commonly performed regional anesthetics in children and are
      performed daily for a host of infra-umbilical surgical procedures. A caudal block is an
      epidural injection, most commonly of local anesthetic into the epidural space as accessed via
      the sacral hiatus. In children, the sacral hiatus is a normally occurring aperture in which
      the epidural space may be accessed with extremely minimal risk; as neural tissue ends more
      proximally. Due to this measure of safety, caudal blocks are preferred in children when
      compared with standard lumbar epidurals. Caudal blocks are performed blindly using palpation
      and tactile feedback to assess if the medication is being administered in the correct
      location. As a result of blind injection, administration of local anesthetic totally or
      partially outside of the correct site can often be unnoticed or identified after a
      significant volume has already been injected. With the potential for toxicity of local
      anesthetic, this may result in either the inability to give a complete dose or an
      unintentional and often unnoticed sham block "incorrect site of injection".
Caudal blocks are one of the most commonly performed regional anesthetics in children and are
      performed daily for a host of infra-umbilical surgical procedures. A caudal block is an
      epidural injection, most commonly of local anesthetic into the epidural space as accessed via
      the sacral hiatus. In children, the sacral hiatus is a normally occurring aperture in which
      the epidural space may be accessed with extremely minimal risk; as neural tissue ends more
      proximally. Due to this measure of safety, caudal blocks are preferred in children when
      compared with standard lumbar epidurals. Caudal blocks are performed blindly using palpation
      and tactile feedback to assess if the medication is being administered in the correct
      location. As a result of blind injection, administration of local anesthetic totally or
      partially outside of the correct site can often be unnoticed or identified after a
      significant volume has already been injected. With the potential for toxicity of local
      anesthetic, this may result in either the inability to give a complete dose or an
      unintentional and often unnoticed sham block "incorrect site of injection".

      Use of ultrasound has been proposed for identification of caudal block placement and correct
      medication spread. However, a recent review of the Pediatric Regional Anesthesia Network
      database reveals that ultrasound is reportedly only used in less that 3% of blocks. The
      benefit of ultrasound is safe and real-time confirmation of injection. Ultrasound allows the
      provider to determine with minimal local anesthetic or even saline injection if the correct
      space is accessed. Without ultrasound, failed blocks are either identified after significant
      percentage of the total dose of local anesthetic is incorrectly administered or intra or post
      operatively when the patient demonstrates a significant opioid requirement. This is
      problematic given that one of the primary benefits of a caudal block in children is the
      ability to avoid opioids.

      Review of local practice here at Texas Children's Hospital for quality improvement purposes
      revealed a failure rate of caudal blocks to be 18%. Failure was defined as a heart rate
      increase with incision of >20% despite a caudal block and >1MAC of gas for the patient age.
      These patients all required opioids both intra and post operatively in addition to surgical
      levels of inhaled anesthetic agent.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single blinded prospective trial in which all patients serve as their own clinical control group.
primary purpose: Treatment
masking: None (Open Label)
masking description: Single blinded prospective trial in which all patients serve as their own clinical control group.
Provider doing the procedure will be blinded to intervention
measure: Identify the rate at which blindly placed caudal blocks are not within the epidural space
time frame: 15 minutes
description: Assess the percentage of providers not recognizing wrong site of injection without ultrasound
measure: Identify the rate at which ultrasound can guide a wrong block into the correct location
time frame: 15 minutes
description: Assess the number of blocks that are require the use of ultrasound to redirect needle into caudal space
measure: Identify if lack of heart rate change on incision can predict successful placement when medication administration is successfully confirmed with ultrasound
time frame: 15 minutes
description: With ultrasound identification of correct caudal injection, (successful block), does lack of heart rate change correlated with successful block
measure: Identify if after using ultrasound to visualize placement, if concentrations of inhaled agents may be reduced in children
time frame: 30 minutes to 3 hours
description: With demonstration of successful caudal injection, can inhaled agent concentration be reduced as calculated by MAC hours
arm group label: Ultrasound
arm group type: Experimental
description: The attending anesthesiologist will perform or instruct the placement of a caudal block according to their standard of practice. At the time of administration of local anesthetic into the caudal space, the study collaborator (SC) will ultrasound the caudal space keeping the provider placing the block blinded to the imaging. The provider placing the block will inject 0.5mL of saline. The provider will then be asked to state if they are correctly in the caudal space or not. If the provider feels they are not in the caudal space, they will re-do the procedure. If the provider fails to identify incorrect location and this is noted by ultrasound, the SC will inform the provider to re-do the procedure.
All study participants will have ultrasound used for caudal block.
intervention type: Diagnostic Test
intervention name: Ultrasound guidance for caudal block
description: The attending anesthesiologist will perform or instruct the placement of a caudal block according to their standard of practice. At the time of administration of local anesthetic into the caudal space, the study collaborator (SC) will ultrasound the caudal space keeping the provider placing the block blinded to the imaging. The provider placing the block will inject 0.5mL of preservative free saline. The provider will then be asked to state if they are correctly in the caudal space or not. If the provider feels they are not in the caudal space, they will re-do the procedure. If the provider fails to identify incorrect location and this is noted by ultrasound, the SC will inform the provider to re-do the procedure
arm group label: Ultrasound
criteria: 
gender: All
minimum age: N/A
maximum age: 7 Years
healthy volunteers: No
last name: Adam C Adler, MD, FAAP
role: Principal Investigator
affiliation: Texas Childrens Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Adam Adler MD, MS, FAAP
investigator title: Assistant Professor
sharing ipd: No
provided document: 