<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/NCT03779568</url>
  </required_header>
  <id_info>
    <org_study_id>STU 082018-026</org_study_id>
    <nct_id>NCT03779568</nct_id>
  </id_info>
  <brief_title>ED50 and ED95 of Isobaric Bupivacaine for Post-Partum Bilateral Tubal Ligation</brief_title>
  <official_title>Determination of ED50 and ED95 of Isobaric Bupivacaine for Post-Partum Bilateral Tubal Ligation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      Spinal anesthesia is one of the preferred anesthetic techniques for post-partum bilateral&#xD;
      tubal ligation (PBTL). Bupivacaine is the most commonly used local anesthetic for neuraxial&#xD;
      anesthesia for post-partum tubal ligation. Typically, hyperbaric bupivacaine would be&#xD;
      injected into the spinal (intrathecal) space via a spinal needle; however, ongoing medication&#xD;
      shortages have resulted in limited availability on a local and national level. One proposed&#xD;
      alternative is isobaric bupivacaine; however, studies investigating its use for post-partum&#xD;
      bilateral tubal ligation are limited.&#xD;
&#xD;
      The purpose of this prospective study is to determine the minimal effective dose (ED50 and&#xD;
      ED95) of isobaric bupivacaine for adequate anesthesia during post-partum tubal ligation after&#xD;
      vaginal delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study proposes to enroll 40 post-partum women who are undergoing elective&#xD;
      post-partum bilateral tubal ligation. The patient will be positioned sitting, and combined&#xD;
      spinal anesthesia will be performed at L2-3 or L3-4 level. The presence of an epidural&#xD;
      catheter enables the provider to supplement the spinal anesthetic if required. The starting&#xD;
      dose of isobaric bupivacaine will be 10 mg based on prior similar studies1,4 and our&#xD;
      institution's current practice. The dose of intrathecal isobaric bupivacaine was decided by&#xD;
      using the up-down sequential method.&#xD;
&#xD;
      The motor block will be graded by a modified Bromage score: Score 1 = complete block, unable&#xD;
      to move feet or knees; 2 = almost complete block, able to move feet only; 3 = partial block,&#xD;
      just able to move knees; 4 = detectable weakness of hip flexion while supine, full flexion of&#xD;
      knees; 5 = no detectable weakness of hip flexion while supine; and 6 = able to perform&#xD;
      partial knee bend. The score of 1 or 2 within 10-15 minutes of injection will be evaluated as&#xD;
      successful motor block.&#xD;
&#xD;
      The success of the sensory spinal block will be noted when bilateral T6 sensory level to&#xD;
      pinprick is attained after 10 mins from the intrathecal drug administration, this is in&#xD;
      accordance with previous studies1.&#xD;
&#xD;
      If spinal anesthesia is inadequate, the epidural catheter will be dosed up for&#xD;
      supplementation. All observations, including block characteristics and the associated outcome&#xD;
      (i.e., adequate or inadequate block), will be evaluated by a dedicated anesthesia provider.&#xD;
&#xD;
      Intraoperative adverse effects, such as hypotension, bradycardia, nausea, or vomiting,&#xD;
      pruritus, or shivering were noted. Hypotension is defined as a decrease of more than 20% in&#xD;
      basal systolic blood pressure within 30 minutes of intrathecal injection. The management of&#xD;
      blood pressure including dose of pressor: phenylephrine and ephedrine will be at the&#xD;
      discretion of the attending anesthesiologist. The use of pressor and anti-emetics will also&#xD;
      be recorded.&#xD;
&#xD;
      The study will be take place in standard clinical context. The study does not deviate from&#xD;
      our current practice, which includes the use of combined spinal anesthesia where the epidural&#xD;
      catheter is available if supplemental local anesthetic is required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">April 9, 2020</completion_date>
  <primary_completion_date type="Actual">June 17, 2019</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success or failure of the intrathecal block</measure>
    <time_frame>Perioperative</time_frame>
    <description>The score of 1 or 2 within 10-15 minutes of injection will be evaluated as successful motor block.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Dose adjustment of bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will receive isobaric bupivacaine based on previous patient experience.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dose adjustment of bupivacaine</intervention_name>
    <description>Spinal bupivacaine dose will be adjusted according to previous patient experience.</description>
    <arm_group_label>Dose adjustment of bupivacaine</arm_group_label>
    <other_name>Spinal bupivacaine dose adjustment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and older&#xD;
&#xD;
          -  Patients undergoing elective post-partum bilateral tubal ligation after vaginal&#xD;
             delivery&#xD;
&#xD;
          -  Patients receiving spinal epidural anesthesia with combination of bupivacaine and&#xD;
             fentanyl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status score &gt;3,&#xD;
&#xD;
          -  Contraindications to neuraxial analgesia&#xD;
&#xD;
          -  Patients in whom a combined spinal epidural cannot be performed&#xD;
&#xD;
          -  Body mass index &gt;40 kg/m2&#xD;
&#xD;
          -  Allergy or hypersensitivity to local anesthetics and fentanyl&#xD;
&#xD;
          -  Severe liver, kidney or respiratory disease.&#xD;
&#xD;
          -  Inability to understand the study protocol&#xD;
&#xD;
          -  Refusal to provide written consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seema Dave, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkland Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 15, 2020</last_update_submitted>
  <last_update_submitted_qc>May 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03779568
org study id: STU 082018-026
nct id: NCT03779568
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Spinal anesthesia is one of the preferred anesthetic techniques for post-partum bilateral
      tubal ligation (PBTL). Bupivacaine is the most commonly used local anesthetic for neuraxial
      anesthesia for post-partum tubal ligation. Typically, hyperbaric bupivacaine would be
      injected into the spinal (intrathecal) space via a spinal needle; however, ongoing medication
      shortages have resulted in limited availability on a local and national level. One proposed
      alternative is isobaric bupivacaine; however, studies investigating its use for post-partum
      bilateral tubal ligation are limited.

      The purpose of this prospective study is to determine the minimal effective dose (ED50 and
      ED95) of isobaric bupivacaine for adequate anesthesia during post-partum tubal ligation after
      vaginal delivery.
This prospective study proposes to enroll 40 post-partum women who are undergoing elective
      post-partum bilateral tubal ligation. The patient will be positioned sitting, and combined
      spinal anesthesia will be performed at L2-3 or L3-4 level. The presence of an epidural
      catheter enables the provider to supplement the spinal anesthetic if required. The starting
      dose of isobaric bupivacaine will be 10 mg based on prior similar studies1,4 and our
      institution's current practice. The dose of intrathecal isobaric bupivacaine was decided by
      using the up-down sequential method.

      The motor block will be graded by a modified Bromage score: Score 1 = complete block, unable
      to move feet or knees; 2 = almost complete block, able to move feet only; 3 = partial block,
      just able to move knees; 4 = detectable weakness of hip flexion while supine, full flexion of
      knees; 5 = no detectable weakness of hip flexion while supine; and 6 = able to perform
      partial knee bend. The score of 1 or 2 within 10-15 minutes of injection will be evaluated as
      successful motor block.

      The success of the sensory spinal block will be noted when bilateral T6 sensory level to
      pinprick is attained after 10 mins from the intrathecal drug administration, this is in
      accordance with previous studies1.

      If spinal anesthesia is inadequate, the epidural catheter will be dosed up for
      supplementation. All observations, including block characteristics and the associated outcome
      (i.e., adequate or inadequate block), will be evaluated by a dedicated anesthesia provider.

      Intraoperative adverse effects, such as hypotension, bradycardia, nausea, or vomiting,
      pruritus, or shivering were noted. Hypotension is defined as a decrease of more than 20% in
      basal systolic blood pressure within 30 minutes of intrathecal injection. The management of
      blood pressure including dose of pressor: phenylephrine and ephedrine will be at the
      discretion of the attending anesthesiologist. The use of pressor and anti-emetics will also
      be recorded.

      The study will be take place in standard clinical context. The study does not deviate from
      our current practice, which includes the use of combined spinal anesthesia where the epidural
      catheter is available if supplemental local anesthetic is required.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Success or failure of the intrathecal block
time frame: Perioperative
description: The score of 1 or 2 within 10-15 minutes of injection will be evaluated as successful motor block.
arm group label: Dose adjustment of bupivacaine
arm group type: Experimental
description: Patient will receive isobaric bupivacaine based on previous patient experience.
intervention type: Other
intervention name: Dose adjustment of bupivacaine
description: Spinal bupivacaine dose will be adjusted according to previous patient experience.
arm group label: Dose adjustment of bupivacaine
other name: Spinal bupivacaine dose adjustment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Seema Dave, MPH
role: Study Chair
affiliation: UT Southwestern Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bupivacaine
sharing ipd: No