<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/NCT03231436</url>
  </required_header>
  <id_info>
    <org_study_id>65/PB/BHorosz/2017</org_study_id>
    <nct_id>NCT03231436</nct_id>
  </id_info>
  <brief_title>Fixed Dose Spinal Bupivacaine for Cesarean Delivery</brief_title>
  <acronym>SpinFix-Bupi</acronym>
  <official_title>Fixed Dose Versus Height - Adjusted Dose of Intrathecal Hyperbaric Bupivacaine With Opioid for Cesarean Delivery: a Prospective Double-blinded Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bartosz Horosz, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre of Postgraduate Medical Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre of Postgraduate Medical Education</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>
      The study is designed to compare the effectiveness of spinal anesthesia performed with fixed&#xD;
      dose of hyperbaric bupivacaine regardless of patient's height and weight and anesthesia with&#xD;
      the dose of bupivacaine that is adjusted to their height. Our clinical experience shows that&#xD;
      spinal anesthesia using specific, relatively high dose of hyperbaric bupivacaine combined&#xD;
      with opioid is very effective, regardless of parturient's weight and height, provides very&#xD;
      good surgical conditions and assures patient's comfort while the rate of anesthesia - related&#xD;
      complications is similar or less. Therefore, using height-adjusted protocols, although&#xD;
      preferred in some centres, might not be necessary in order to provide good anaesthesia for&#xD;
      cesarean delivery. Fixed dose regimen may have some additional advantages in obstetric&#xD;
      anesthesia settings, as many of cesareans are performed out of hours, giving less room for&#xD;
      mistakes in less experienced hands.&#xD;
&#xD;
      Two groups of parturients undergoing cesarean section are to be compared: anesthetized with&#xD;
      fixed-dose regimen (intervention group) and anesthetized with height-adjusted dose regimen&#xD;
      (control group). Patients are going to be randomized to one of the above groups, two&#xD;
      anesthetists will be involved in anesthetic procedure: anesthetist that looks after the&#xD;
      patient throughout the procedure will be blinded to the dose of anesthetic given&#xD;
      intrathecally. Therefore his judgment of anesthetic effectiveness is not going to be biased&#xD;
      and all patients will receive the same perioperative care in terms of fluid therapy,&#xD;
      management of possible anesthesia - related complications and postoperative pain control.&#xD;
&#xD;
      Rate of effective spinal anesthetics, defined as adequate block level and no need for&#xD;
      additional intraoperative analgesia has been established as primary outcome measure.&#xD;
      Secondary outcome measures are rate of complications and amount of opioids used&#xD;
      postoperatively. These are going to be statistically compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">June 3, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adequacy of spinal anesthesia</measure>
    <time_frame>60min</time_frame>
    <description>Level of surgical anesthesia at least T5 and no need for additional intraoperative analgesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of complications</measure>
    <time_frame>60min</time_frame>
    <description>Hypotension, bradycardia, nausea, vomiting,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative opioid consumption</measure>
    <time_frame>24hours</time_frame>
    <description>Time to the first dose of morphine and total amount of morphine used postoperatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Spinal Anesthesia</condition>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Fixed dose of 12.5mg bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants that receive the same dose of intrathecal bupivacaine and 25mcg of fentanyl, regardless of their height.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Height-adjusted dose of bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants that receive the dose of intrathecal bupivacaine adjusted to their height and 25mcg of fentanyl</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fixed dose of 12.5mg bupivacaine</intervention_name>
    <description>Spinal anesthesia performed with 12,5mg of bupivacaine with 25mcg fentanyl for cesarean section</description>
    <arm_group_label>Fixed dose of 12.5mg bupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Height-adjusted dose of bupivacaine</intervention_name>
    <description>Spinal anesthesia performed with height-adjusted dose of bupivacaine with 25mcg fentanyl for cesarean section</description>
    <arm_group_label>Height-adjusted dose of bupivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  singleton pregnancy above 37Hbd scheduled for elective cesarean section&#xD;
&#xD;
          -  ASA 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  absolute contraindications to spinal anesthesia&#xD;
&#xD;
          -  delivery in progress&#xD;
&#xD;
          -  non-singleton pregnancy&#xD;
&#xD;
          -  BMI&gt;35&#xD;
&#xD;
          -  ultrasound - based estimation of fetal weight below 10 percentile&#xD;
&#xD;
          -  pregnancy-induced hypertension&#xD;
&#xD;
          -  more than 2 cesarean sections in patient's medical history&#xD;
&#xD;
          -  significantly increased risk of obstetric hemorrhage (placenta previa)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Malgorzata Malec-Milewska, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre of Postgraduate Medical Education</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care</name>
      <address>
        <city>Warsaw</city>
        <zip>01-813</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>June 8, 2019</last_update_submitted>
  <last_update_submitted_qc>June 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre of Postgraduate Medical Education</investigator_affiliation>
    <investigator_full_name>Bartosz Horosz, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>intrathecal bupivacaine</keyword>
  <keyword>hyperbaric bupivacaine</keyword>
  <keyword>failed spinal</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03231436
org study id: 65/PB/BHorosz/2017
nct id: NCT03231436
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The study is designed to compare the effectiveness of spinal anesthesia performed with fixed
      dose of hyperbaric bupivacaine regardless of patient's height and weight and anesthesia with
      the dose of bupivacaine that is adjusted to their height. Our clinical experience shows that
      spinal anesthesia using specific, relatively high dose of hyperbaric bupivacaine combined
      with opioid is very effective, regardless of parturient's weight and height, provides very
      good surgical conditions and assures patient's comfort while the rate of anesthesia - related
      complications is similar or less. Therefore, using height-adjusted protocols, although
      preferred in some centres, might not be necessary in order to provide good anaesthesia for
      cesarean delivery. Fixed dose regimen may have some additional advantages in obstetric
      anesthesia settings, as many of cesareans are performed out of hours, giving less room for
      mistakes in less experienced hands.

      Two groups of parturients undergoing cesarean section are to be compared: anesthetized with
      fixed-dose regimen (intervention group) and anesthetized with height-adjusted dose regimen
      (control group). Patients are going to be randomized to one of the above groups, two
      anesthetists will be involved in anesthetic procedure: anesthetist that looks after the
      patient throughout the procedure will be blinded to the dose of anesthetic given
      intrathecally. Therefore his judgment of anesthetic effectiveness is not going to be biased
      and all patients will receive the same perioperative care in terms of fluid therapy,
      management of possible anesthesia - related complications and postoperative pain control.

      Rate of effective spinal anesthetics, defined as adequate block level and no need for
      additional intraoperative analgesia has been established as primary outcome measure.
      Secondary outcome measures are rate of complications and amount of opioids used
      postoperatively. These are going to be statistically compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Adequacy of spinal anesthesia
time frame: 60min
description: Level of surgical anesthesia at least T5 and no need for additional intraoperative analgesia
measure: Number of complications
time frame: 60min
description: Hypotension, bradycardia, nausea, vomiting,
measure: Postoperative opioid consumption
time frame: 24hours
description: Time to the first dose of morphine and total amount of morphine used postoperatively
arm group label: Fixed dose of 12.5mg bupivacaine
arm group type: Experimental
description: Participants that receive the same dose of intrathecal bupivacaine and 25mcg of fentanyl, regardless of their height.
arm group label: Height-adjusted dose of bupivacaine
arm group type: Active Comparator
description: Participants that receive the dose of intrathecal bupivacaine adjusted to their height and 25mcg of fentanyl
intervention type: Drug
intervention name: Fixed dose of 12.5mg bupivacaine
description: Spinal anesthesia performed with 12,5mg of bupivacaine with 25mcg fentanyl for cesarean section
arm group label: Fixed dose of 12.5mg bupivacaine
intervention type: Drug
intervention name: Height-adjusted dose of bupivacaine
description: Spinal anesthesia performed with height-adjusted dose of bupivacaine with 25mcg fentanyl for cesarean section
arm group label: Height-adjusted dose of bupivacaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Malgorzata Malec-Milewska, MD
role: Study Chair
affiliation: Centre of Postgraduate Medical Education
facility: 
country: Poland
responsible party type: Sponsor-Investigator
investigator affiliation: Centre of Postgraduate Medical Education
investigator full name: Bartosz Horosz, MD
investigator title: Principal Investigator
mesh term: Bupivacaine