<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/NCT02976571</url>
  </required_header>
  <id_info>
    <org_study_id>0198-16-WOMC</org_study_id>
    <nct_id>NCT02976571</nct_id>
  </id_info>
  <brief_title>Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief</brief_title>
  <official_title>Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy,&#xD;
      regarding post operative pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      4 randomly assigned groups. Grop 1 will get sub cutaneous and intraperitoneal marcain. Grop 2&#xD;
      will get sub cutaneous marcaine and intraperitoneal saline. Grop 3 will get sub cutaneus&#xD;
      saline and intraperitoneal marcaine. Grop 4 will get ub cutaneous and intraperitoneal saline&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain level during movement, 8 hours after laparoscopy</measure>
    <time_frame>8 hours</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Sub cutaneous+Intraperitoneal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub cutaneous+Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo+Intraperitoneal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo+Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Sub cutaneous and/or Intraperitoneal Marcaine application</description>
    <arm_group_label>Placebo+Intraperitoneal</arm_group_label>
    <arm_group_label>Placebo+Placebo</arm_group_label>
    <arm_group_label>Sub cutaneous+Intraperitoneal</arm_group_label>
    <arm_group_label>Sub cutaneous+Placebo</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective laparoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to&#xD;
             pelvic pain Pregnancy Operations lasts more than 3 hours&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ohad Gluck, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wolfson Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ohad Gluck, MD</last_name>
    <phone>97235028329</phone>
    <email>ohadgluck@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elad Barer, MD</last_name>
    <phone>9725028329</phone>
    <email>elad.barber@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wolfson medical center</name>
      <address>
        <city>H̱olon</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ohad Gluck, MD</last_name>
      <phone>97235028329</phone>
      <email>ohadgluck@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>May 8, 2018</last_update_submitted>
  <last_update_submitted_qc>May 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2018</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>Pain, Postoperative</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <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/NCT02976571
org study id: 0198-16-WOMC
nct id: NCT02976571
lead sponsor: 
has dmc: No
A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy,
      regarding post operative pain.
4 randomly assigned groups. Grop 1 will get sub cutaneous and intraperitoneal marcain. Grop 2
      will get sub cutaneous marcaine and intraperitoneal saline. Grop 3 will get sub cutaneus
      saline and intraperitoneal marcaine. Grop 4 will get ub cutaneous and intraperitoneal saline
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain level during movement, 8 hours after laparoscopy
time frame: 8 hours
arm group label: Sub cutaneous+Intraperitoneal
arm group type: Experimental
description: Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine
arm group label: Sub cutaneous+Placebo
arm group type: Active Comparator
description: Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%
arm group label: Placebo+Intraperitoneal
arm group type: Active Comparator
description: Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine
arm group label: Placebo+Placebo
arm group type: Placebo Comparator
description: Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%
intervention type: Drug
intervention name: Bupivacaine
description: Sub cutaneous and/or Intraperitoneal Marcaine application
arm group label: Placebo+Intraperitoneal
arm group label: Placebo+Placebo
arm group label: Sub cutaneous+Intraperitoneal
arm group label: Sub cutaneous+Placebo
other name: Marcaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ohad Gluck, MD
role: Principal Investigator
affiliation: Wolfson Medical Center
last name: Ohad Gluck, MD
phone: 97235028329
email: ohadgluck@gmail.com
last name: Elad Barer, MD
phone: 9725028329
email: elad.barber@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Postoperative Complications
mesh term: Bupivacaine
sharing ipd: No