<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/NCT02973451</url>
  </required_header>
  <id_info>
    <org_study_id>3</org_study_id>
    <nct_id>NCT02973451</nct_id>
  </id_info>
  <brief_title>Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Infiltration in Gynecologic Laparoscopy.</brief_title>
  <official_title>Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Local Anesthetic Infiltration in Gynecologic Laparoscopy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site&#xD;
      Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      two groups of patients who are eligible for Gynecologic Laparoscopy were randomized to either&#xD;
      Laparoscopic Guided Transversus Abdominis Plane Block or Trocar Site Infiltration at the end&#xD;
      of the operation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Scores</measure>
    <time_frame>24 Hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Post Operative Local Anaesthesia</condition>
  <arm_group>
    <arm_group_label>Laparoscopic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic Guided Transversus Abdominis Plane Block using Bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>local</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trocar Site Infiltration of Bupivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Laparoscopic Guided Bupivacaine</intervention_name>
    <description>Bupivacaine Laparoscopic GuidedTransversus Abdominis Plane Block</description>
    <arm_group_label>Laparoscopic</arm_group_label>
    <other_name>marcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>local Bupivacaine</intervention_name>
    <description>Bupivacaine Trocar Site Infiltration</description>
    <arm_group_label>local</arm_group_label>
    <other_name>marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients Need Gynecologic Laparoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed with chronic pain syndrome&#xD;
&#xD;
          -  have a postoperative intraperitoneal drain&#xD;
&#xD;
          -  necessitating alteration to laparotomy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ibrahim A el sharkwy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zagazig University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>September 3, 2018</last_update_submitted>
  <last_update_submitted_qc>September 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>IBRAHIM ABD ELGAFOR</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <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/NCT02973451
org study id: 3
nct id: NCT02973451
lead sponsor: 
has dmc: Yes
to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site
      Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.
two groups of patients who are eligible for Gynecologic Laparoscopy were randomized to either
      Laparoscopic Guided Transversus Abdominis Plane Block or Trocar Site Infiltration at the end
      of the operation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain Scores
time frame: 24 Hours
arm group label: Laparoscopic
arm group type: Active Comparator
description: Laparoscopic Guided Transversus Abdominis Plane Block using Bupivacaine
arm group label: local
arm group type: Active Comparator
description: Trocar Site Infiltration of Bupivacaine
intervention type: Drug
intervention name: Laparoscopic Guided Bupivacaine
description: Bupivacaine Laparoscopic GuidedTransversus Abdominis Plane Block
arm group label: Laparoscopic
other name: marcaine
intervention type: Drug
intervention name: local Bupivacaine
description: Bupivacaine Trocar Site Infiltration
arm group label: local
other name: marcaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ibrahim A el sharkwy, MD
role: Principal Investigator
affiliation: Zagazig University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: IBRAHIM ABD ELGAFOR
investigator title: assistant professor
mesh term: Bupivacaine