<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/NCT03770013</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/182/18</org_study_id>
    <nct_id>NCT03770013</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine Versus Clonidine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section</brief_title>
  <official_title>Role of Co-administered Dexmedetomidine Or Clonidine With Bupivacaine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section: A Randomized, Double-blind Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Aim to study the efficacy of co-administered Dexmedetomidine Or Clonidine with Bupivacaine&#xD;
      and that of bupivacaine 0.25% alone for Transversus Abdominis Plane (TAP) Block for&#xD;
      Postoperative Analgesia in Patients Undergoing Elective Caesarean Section.&#xD;
&#xD;
        -  Group 1: bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml&#xD;
           each side) was used for the TAP block.)&#xD;
&#xD;
        -  Group 2: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml&#xD;
           each side) was used for the TAP&#xD;
&#xD;
        -  Group3: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used&#xD;
           for the TAP A prospective Randomized Interventional double-blind study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women, following Caesarean delivery, have even more compelling reasons to receive optimal&#xD;
      post-operative pain relief, for improved maternal and neonatal well-being. Also, adequate&#xD;
      pain relief helps the patient to ambulate early and prevent any thrombotic incidents .&#xD;
      Dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of&#xD;
      medetomidine that displays specific and selective α 2-adrenoceptor agonist activity and&#xD;
      causes sedation, analgesia without any delirium, or respiratory depression. The mechanism of&#xD;
      action is unique and differs from those of currently used agents, including clonidine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>
    <intervention_model_description>A prospective Randomized Interventional double-blind study.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double-blind study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The time for first rescue analgesia after the TAP block</measure>
    <time_frame>24 hours post operative</time_frame>
    <description>calculation the time needed for first rescue analgesia after the TAP block</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total dose of rescue analgesia</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>calculation of Total dose of rescue analgesia required in 24 h post-operatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>Adverse effects like pruritus, nausea and vomiting, hypotension, bradycardia, and sedation.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>bupivacaine 0.25% and Dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bupivacaine and clonidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bupivacaine and placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupivacaine</intervention_name>
    <description>bupivacaine 0.25% a total volume of 40 ml (20 ml each side</description>
    <arm_group_label>bupivacaine 0.25% and Dexmedetomidine</arm_group_label>
    <arm_group_label>bupivacaine and clonidine</arm_group_label>
    <arm_group_label>bupivacaine and placebo</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine 0.5 mcg/kg</description>
    <arm_group_label>bupivacaine 0.25% and Dexmedetomidine</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>clonidine</intervention_name>
    <description>1ug/kg clonidine</description>
    <arm_group_label>bupivacaine and clonidine</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>add placebo 9normal saline)</description>
    <arm_group_label>bupivacaine and placebo</arm_group_label>
    <other_name>placebo comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parturients scheduled to undergo cesarean section under spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refused spinal anesthesia&#xD;
&#xD;
          -  women with chronic pelvic pain or on chronic morphine use&#xD;
&#xD;
          -  history of drug allergy&#xD;
&#xD;
          -  coagulation disorder&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patients Undergoing Elective Caesarean Section.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hany f sallam, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aswan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aswan University</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>hany farouk</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Bupivacaine</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Clonidine</keyword>
  <keyword>Transversus Abdominis Plane Block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clonidine</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03770013
org study id: aswu/182/18
nct id: NCT03770013
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aim to study the efficacy of co-administered Dexmedetomidine Or Clonidine with Bupivacaine
      and that of bupivacaine 0.25% alone for Transversus Abdominis Plane (TAP) Block for
      Postoperative Analgesia in Patients Undergoing Elective Caesarean Section.

        -  Group 1: bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml
           each side) was used for the TAP block.)

        -  Group 2: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml
           each side) was used for the TAP

        -  Group3: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used
           for the TAP A prospective Randomized Interventional double-blind study.
Women, following Caesarean delivery, have even more compelling reasons to receive optimal
      post-operative pain relief, for improved maternal and neonatal well-being. Also, adequate
      pain relief helps the patient to ambulate early and prevent any thrombotic incidents .
      Dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of
      medetomidine that displays specific and selective α 2-adrenoceptor agonist activity and
      causes sedation, analgesia without any delirium, or respiratory depression. The mechanism of
      action is unique and differs from those of currently used agents, including clonidine.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective Randomized Interventional double-blind study.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double-blind study.
measure: The time for first rescue analgesia after the TAP block
time frame: 24 hours post operative
description: calculation the time needed for first rescue analgesia after the TAP block
measure: Total dose of rescue analgesia
time frame: 24 hours postoperative
description: calculation of Total dose of rescue analgesia required in 24 h post-operatively
measure: Adverse effects
time frame: 24 hours postoperative
description: Adverse effects like pruritus, nausea and vomiting, hypotension, bradycardia, and sedation.
arm group label: bupivacaine 0.25% and Dexmedetomidine
arm group type: Active Comparator
description: bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)
arm group label: bupivacaine and clonidine
arm group type: Active Comparator
description: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP
arm group label: bupivacaine and placebo
arm group type: Placebo Comparator
description: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP
intervention type: Drug
intervention name: bupivacaine
description: bupivacaine 0.25% a total volume of 40 ml (20 ml each side
arm group label: bupivacaine 0.25% and Dexmedetomidine
arm group label: bupivacaine and clonidine
arm group label: bupivacaine and placebo
other name: Active Comparator
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine 0.5 mcg/kg
arm group label: bupivacaine 0.25% and Dexmedetomidine
other name: Active Comparator
intervention type: Drug
intervention name: clonidine
description: 1ug/kg clonidine
arm group label: bupivacaine and clonidine
other name: Active Comparator
intervention type: Drug
intervention name: placebo
description: add placebo 9normal saline)
arm group label: bupivacaine and placebo
other name: placebo comparator
criteria: 
gender: Female
gender based: Yes
gender description: Patients Undergoing Elective Caesarean Section.
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: hany f sallam, md
role: Principal Investigator
affiliation: Aswan University Hospital
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: Principal Investigator
mesh term: Pain, Postoperative
mesh term: Clonidine
mesh term: Dexmedetomidine
mesh term: Bupivacaine
sharing ipd: Undecided