<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/NCT03781388</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00101530</org_study_id>
    <nct_id>NCT03781388</nct_id>
  </id_info>
  <brief_title>ED90 for Hyperbaric Bupivacaine in Super Obese Parturients</brief_title>
  <official_title>ED90 for Hyperbaric Bupivacaine in Spinal Anesthesia for Cesarean Delivery in Super Obese Parturients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the&#xD;
      super obese population undergoing cesarean section under a combined spinal epidural&#xD;
      technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">December 6, 2022</completion_date>
  <primary_completion_date type="Actual">December 6, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Blinded study drugs will be prepared by an anesthesia provider not involved in the study. The anesthesia provider providing care to the patient will be blinded to the dosage of the hyperbaric bupivacaine. In order to preserve the blinding of the provider, the total volume of study drug will be maintained at a constant of 2.05mL. The difference in total volume based on the variation of hyperbaric bupivacaine dosing will be replaced with preservative free normal saline.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of successful blocks for induction (success induction)</measure>
    <time_frame>10 minutes after intrathecal drug administration</time_frame>
    <description>bilateral T6 sensory level to pinprick by</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of successful blocks for operation (success operation)</measure>
    <time_frame>during surgery up to 90 minutes after intrathecal injection</time_frame>
    <description>successful initial sensory level without requiring additional epidural anesthetic</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Obesity, Morbid</condition>
  <condition>Spinal Anesthesia</condition>
  <condition>Cesarean Delivery</condition>
  <arm_group>
    <arm_group_label>Starting dose of Bupivacaine (9 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subsequent dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Determination of the dose will rely on the outcomes of the preceding 7 patients receiving the same dose, as the number of previous patients to consider is a function of the target dose. Among all patients who received a certain dose, a proportion of successful outcomes will be determined (P(d)); if P(d) &lt;0.90, and at least one of the previous 7 patients who received the same dose had an unsatisfactory outcome, the next patient will receive a pre-determined increment of 0.75 mg of bupivacaine. Alternatively, if P(d) 0.90 and the previous 7 patients who received the same dose had successful outcomes, the next patient will receive a pre-determined decrement of 0.75mg of bupivacaine. Otherwise, the dose will remain the same.</description>
    <arm_group_label>Starting dose of Bupivacaine (9 mg)</arm_group_label>
    <arm_group_label>Subsequent dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) class 2 and 3&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Gestational age &gt; 36 weeks&#xD;
&#xD;
          -  Scheduled for cesarean delivery under combined spinal epidural anesthesia&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  BMI &gt; 50 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of past or current intravenous drug or chronic opioid abuse&#xD;
&#xD;
          -  Allergy or contraindication to any study medications&#xD;
&#xD;
          -  Intrapartum cesarean delivery under epidural anesthesia&#xD;
&#xD;
          -  Cesarean delivery under general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashraf S Habib, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bupivacaine ED90</keyword>
  <keyword>Cesarean Delivery</keyword>
  <keyword>Obesity</keyword>
  <keyword>Spinal Anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <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/NCT03781388
org study id: Pro00101530
nct id: NCT03781388
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the
      super obese population undergoing cesarean section under a combined spinal epidural
      technique.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Blinded study drugs will be prepared by an anesthesia provider not involved in the study. The anesthesia provider providing care to the patient will be blinded to the dosage of the hyperbaric bupivacaine. In order to preserve the blinding of the provider, the total volume of study drug will be maintained at a constant of 2.05mL. The difference in total volume based on the variation of hyperbaric bupivacaine dosing will be replaced with preservative free normal saline.
measure: Percent of successful blocks for induction (success induction)
time frame: 10 minutes after intrathecal drug administration
description: bilateral T6 sensory level to pinprick by
measure: Percent of successful blocks for operation (success operation)
time frame: during surgery up to 90 minutes after intrathecal injection
description: successful initial sensory level without requiring additional epidural anesthetic
arm group label: Starting dose of Bupivacaine (9 mg)
arm group type: Experimental
description: The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).
arm group label: Subsequent dose
arm group type: Experimental
intervention type: Drug
intervention name: Bupivacaine
description: Determination of the dose will rely on the outcomes of the preceding 7 patients receiving the same dose, as the number of previous patients to consider is a function of the target dose. Among all patients who received a certain dose, a proportion of successful outcomes will be determined (P(d)); if P(d) <0.90, and at least one of the previous 7 patients who received the same dose had an unsatisfactory outcome, the next patient will receive a pre-determined increment of 0.75 mg of bupivacaine. Alternatively, if P(d) 0.90 and the previous 7 patients who received the same dose had successful outcomes, the next patient will receive a pre-determined decrement of 0.75mg of bupivacaine. Otherwise, the dose will remain the same.
arm group label: Starting dose of Bupivacaine (9 mg)
arm group label: Subsequent dose
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ashraf S Habib, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity, Morbid
mesh term: Bupivacaine
sharing ipd: No