<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/NCT02233309</url>
  </required_header>
  <id_info>
    <org_study_id>IRB14-00119</org_study_id>
    <nct_id>NCT02233309</nct_id>
  </id_info>
  <brief_title>A Prospective Observational Study of Epidural Pressures During Caudal Epidural in the Pediatric Population</brief_title>
  <official_title>Epidural Pressure Changes Following Caudal Blockade: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jessica Goeller</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective study of epidural pressure changes when local anesthetic is&#xD;
      injected from the caudal route. All patients will receive the same weight based volume dose&#xD;
      of local anesthetic after induction of general anesthesia, and a CVP transducer will be&#xD;
      attached to the standard caudal needle for measurement of pressure: under the skin, after&#xD;
      entering the epidural space, and every 15 seconds for 3 minutes after completion of injection&#xD;
      with the needle in situ. The placement of the caudal epidural will follow current standard of&#xD;
      care and administration, the only variation will be the addition of a pressure transducer to&#xD;
      the stopcock where the local anesthetic syringe is attached that will allow for pressure&#xD;
      monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval of the Internal Review Board, the patients and families will be given the&#xD;
      opportunity to participate in the proposed research study if inclusion criteria are met. The&#xD;
      patient/family will sign the anesthesia consent form, as per protocol, by initialing the box&#xD;
      at the bottom that states 'I do want, if indicated, regional anesthetic techniques employed&#xD;
      for anesthetic maintenance and/or port operative pain relief for my child.' The primary&#xD;
      anesthesia team (anesthesiologist/CNRA/resident) will be made aware that the need for a&#xD;
      pressure transducer for the caudal epidural injection will be required and that a member of&#xD;
      the research team will be documenting pressures during the procedure. Premedication with&#xD;
      midazolam will be at the discretion of the attending anesthesiologist covering the case.&#xD;
      Anesthesia induction may be performed with either intravenous medications or mask inhalation&#xD;
      at the attending anesthesiologist's discretion; however no narcotics will be administered&#xD;
      during induction, as is common when a caudal epidural is utilized for post-operative pain&#xD;
      control. The airway will be secured using an oral endotracheal tube or laryngeal mask airway&#xD;
      (LMA).&#xD;
&#xD;
      The single shot caudal epidural block with pressure monitoring will be performed by one of&#xD;
      the study investigators. Ropivicaine/Bupivacaine 0.125-0.25% will be used as the local&#xD;
      anesthetic for the caudal epidural with a total dose not to exceed 1 ml/kg. Pressure&#xD;
      transduction will be constantly in place, with pressures being recorded by a research nurse:&#xD;
      1) prior to entering the epidural space, but after needle introduction under the skin, 2)&#xD;
      after loss of resistance upon entering the epidural space, 3) at 5 second intervals during&#xD;
      injection of the 1 mL/kg bolus of local anesthetic 4) continuing with pressure monitoring for&#xD;
      an additional minute, in 10 second increments, after the injection is completed. Following&#xD;
      placement of the block, a band-aidwill be placed, where appropriate, and the patient will be&#xD;
      prepped for the surgical procedure. The primary anesthesia team will continue delivering the&#xD;
      general anesthetic for the remainder of the case. Maintenance anesthesia will be carried out&#xD;
      per our usual routine.&#xD;
&#xD;
      Upon completion of the surgical procedure, the patient's airway device will be removed and&#xD;
      the patient will be transferred to the post-anesthesia care unit (PACU). In the PACU, the&#xD;
      principal or co-investigator will review the patient's treatment needs for pain in the PACU&#xD;
      to determine whether the block was efficacious; fentanyl 0.5 µg/kg, or the&#xD;
      morphine-equivalent dose, will be administered as necessary based on the pain assessment. The&#xD;
      patients will be discharged from PACU when discharge criteria are met per the Aldrete score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Pressure in the Caudal Epidural Space</measure>
    <time_frame>Immediately post bolus</time_frame>
    <description>After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Anesthesia, Caudal</condition>
  <arm_group>
    <arm_group_label>Monitoring of pressures during caudal anesthesia</arm_group_label>
    <description>Patients receiving caudal anesthesia as standard of care for a surgical procedure.&#xD;
Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Monitoring of pressures during caudal anesthesia</intervention_name>
    <description>The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.</description>
    <arm_group_label>Monitoring of pressures during caudal anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who will be receiving caudal anesthesia as part of their surgical procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA physical status I or II&#xD;
&#xD;
          2. Weight ≥ 3 kilograms&#xD;
&#xD;
          3. Undergoing a lower abdominal/pelvic or urologic procedure where caudal epidural&#xD;
             anesthesia is a beneficial adjunct&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Co-morbid diseases (cardiac, pulmonary, neurological disease)&#xD;
&#xD;
          2. Patients with sacral deformities contraindicating a caudal epidural&#xD;
&#xD;
          3. Use of therapeutic dose anticoagulants or presence of a bleeding disorder&#xD;
&#xD;
          4. Other co-existing conditions would preclude the use of neuraxial blockade&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica Goeller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <results_first_submitted>May 13, 2015</results_first_submitted>
  <results_first_submitted_qc>May 13, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 28, 2015</results_first_posted>
  <last_update_submitted>May 13, 2015</last_update_submitted>
  <last_update_submitted_qc>May 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Jessica Goeller</investigator_full_name>
    <investigator_title>Anesthesiology Fellow</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Monitoring of Pressures During Caudal Anesthesia</title>
          <description>Patients receiving caudal anesthesia as standard of care for a surgical procedure.&#xD;
Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.&#xD;
Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Monitoring of Pressures During Caudal Anesthesia</title>
          <description>Patients receiving caudal anesthesia as standard of care for a surgical procedure.&#xD;
Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.&#xD;
Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.21" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pressure in the Caudal Epidural Space</title>
        <description>After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.</description>
        <time_frame>Immediately post bolus</time_frame>
        <population>Due to errors in data collection or protocol violations, 5 patients were excluded leaving 31 patients for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Monitoring of Pressures During Caudal Anesthesia</title>
            <description>Patients receiving caudal anesthesia as standard of care for a surgical procedure.&#xD;
Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.&#xD;
Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pressure in the Caudal Epidural Space</title>
          <description>After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.</description>
          <population>Due to errors in data collection or protocol violations, 5 patients were excluded leaving 31 patients for analysis.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="192.5" spread="93.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Monitoring of Pressures During Caudal Anesthesia</title>
          <description>Patients receiving caudal anesthesia as standard of care for a surgical procedure.&#xD;
Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.&#xD;
Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jessica K. Goeller, DO</name_or_title>
      <organization>University of Nebraska Children's Hospital &amp; Medical Center</organization>
      <phone>(402) 955-4303</phone>
      <email>JGoeller@childrensOmaha.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02233309
org study id: IRB14-00119
nct id: NCT02233309
lead sponsor: 
has dmc: No
This study is a prospective study of epidural pressure changes when local anesthetic is
      injected from the caudal route. All patients will receive the same weight based volume dose
      of local anesthetic after induction of general anesthesia, and a CVP transducer will be
      attached to the standard caudal needle for measurement of pressure: under the skin, after
      entering the epidural space, and every 15 seconds for 3 minutes after completion of injection
      with the needle in situ. The placement of the caudal epidural will follow current standard of
      care and administration, the only variation will be the addition of a pressure transducer to
      the stopcock where the local anesthetic syringe is attached that will allow for pressure
      monitoring.
After approval of the Internal Review Board, the patients and families will be given the
      opportunity to participate in the proposed research study if inclusion criteria are met. The
      patient/family will sign the anesthesia consent form, as per protocol, by initialing the box
      at the bottom that states 'I do want, if indicated, regional anesthetic techniques employed
      for anesthetic maintenance and/or port operative pain relief for my child.' The primary
      anesthesia team (anesthesiologist/CNRA/resident) will be made aware that the need for a
      pressure transducer for the caudal epidural injection will be required and that a member of
      the research team will be documenting pressures during the procedure. Premedication with
      midazolam will be at the discretion of the attending anesthesiologist covering the case.
      Anesthesia induction may be performed with either intravenous medications or mask inhalation
      at the attending anesthesiologist's discretion; however no narcotics will be administered
      during induction, as is common when a caudal epidural is utilized for post-operative pain
      control. The airway will be secured using an oral endotracheal tube or laryngeal mask airway
      (LMA).

      The single shot caudal epidural block with pressure monitoring will be performed by one of
      the study investigators. Ropivicaine/Bupivacaine 0.125-0.25% will be used as the local
      anesthetic for the caudal epidural with a total dose not to exceed 1 ml/kg. Pressure
      transduction will be constantly in place, with pressures being recorded by a research nurse:
      1) prior to entering the epidural space, but after needle introduction under the skin, 2)
      after loss of resistance upon entering the epidural space, 3) at 5 second intervals during
      injection of the 1 mL/kg bolus of local anesthetic 4) continuing with pressure monitoring for
      an additional minute, in 10 second increments, after the injection is completed. Following
      placement of the block, a band-aidwill be placed, where appropriate, and the patient will be
      prepped for the surgical procedure. The primary anesthesia team will continue delivering the
      general anesthetic for the remainder of the case. Maintenance anesthesia will be carried out
      per our usual routine.

      Upon completion of the surgical procedure, the patient's airway device will be removed and
      the patient will be transferred to the post-anesthesia care unit (PACU). In the PACU, the
      principal or co-investigator will review the patient's treatment needs for pain in the PACU
      to determine whether the block was efficacious; fentanyl 0.5 µg/kg, or the
      morphine-equivalent dose, will be administered as necessary based on the pain assessment. The
      patients will be discharged from PACU when discharge criteria are met per the Aldrete score.
observational model: Case-Only
time perspective: Prospective
measure: Pressure in the Caudal Epidural Space
time frame: Immediately post bolus
description: After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.
arm group label: Monitoring of pressures during caudal anesthesia
description: Patients receiving caudal anesthesia as standard of care for a surgical procedure.
Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.
intervention type: Other
intervention name: Monitoring of pressures during caudal anesthesia
description: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.
arm group label: Monitoring of pressures during caudal anesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jessica Goeller, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Jessica Goeller
investigator title: Anesthesiology Fellow
mesh term: Anesthetics
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 