<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/NCT04405336</url>
  </required_header>
  <id_info>
    <org_study_id>tab block</org_study_id>
    <nct_id>NCT04405336</nct_id>
  </id_info>
  <brief_title>Tab Block and Patient Controlled Analgesia in CS</brief_title>
  <official_title>Effect of Tab Block and Patient Controlled Analgesia in Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aljazeera Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aljazeera 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>
      cesarean section rate become increasing nowadays&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      indication of cesarean section are different from case to case and the use of pain&#xD;
      controlling agents is very important to relieve post operative pain&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 2021</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of women who will feel less pain post CS</measure>
    <time_frame>2 days</time_frame>
    <description>the degree of pain that will be felt post CS</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>giving tab block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>giving patients tab block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>giving PCA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Giving PCA to patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients who will not receive PCA or tab block</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No tab block or PCA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tab block</intervention_name>
    <description>injection of tab block to women who are doing cs</description>
    <arm_group_label>giving tab block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PCA</intervention_name>
    <description>giving women PCA</description>
    <arm_group_label>giving PCA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>women who will not receive tab block or PCA</intervention_name>
    <description>no tab block or PCA will be given</description>
    <arm_group_label>giving PCA</arm_group_label>
    <arm_group_label>giving tab block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women coming for an elective CS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women who has a n emergency CS or complicated normal deivery needs urgent CS&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women undergoing CS</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud Alalfy, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Algezeera hospitaland National Research Centre ,Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aljazeera( Al Gazeera) hospital</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 21, 2021</last_update_submitted>
  <last_update_submitted_qc>May 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_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/NCT04405336
org study id: tab block
nct id: NCT04405336
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
cesarean section rate become increasing nowadays
indication of cesarean section are different from case to case and the use of pain
      controlling agents is very important to relieve post operative pain
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: The number of women who will feel less pain post CS
time frame: 2 days
description: the degree of pain that will be felt post CS
arm group label: giving tab block
arm group type: Active Comparator
description: giving patients tab block
arm group label: giving PCA
arm group type: Active Comparator
description: Giving PCA to patients
arm group label: Patients who will not receive PCA or tab block
arm group type: No Intervention
description: No tab block or PCA
intervention type: Drug
intervention name: tab block
description: injection of tab block to women who are doing cs
arm group label: giving tab block
intervention type: Drug
intervention name: PCA
description: giving women PCA
arm group label: giving PCA
intervention type: Drug
intervention name: women who will not receive tab block or PCA
description: no tab block or PCA will be given
arm group label: giving PCA
arm group label: giving tab block
criteria: 
gender: Female
gender based: Yes
gender description: Women undergoing CS
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud Alalfy, PhD
role: Study Chair
affiliation: Algezeera hospitaland National Research Centre ,Egypt
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Agnosia