<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/NCT04468685</url>
  </required_header>
  <id_info>
    <org_study_id>12-2020</org_study_id>
    <nct_id>NCT04468685</nct_id>
  </id_info>
  <brief_title>Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy</brief_title>
  <official_title>Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Hepatology &amp; Tropical Medicine Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Hepatology &amp; Tropical Medicine Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal&#xD;
      invasiveness, less post-operative pain and early recovery when compared to the open&#xD;
      conventional cholecystectomy. However, patients who have undergone LC still complain of&#xD;
      postoperative pain. It has been reported that ondansetron produces numbness when injected&#xD;
      under the skin and has local anesthetic effect that is 15 times more potent than lidocaine&#xD;
      the most widely used local anesthetic and probably explains its antiemetic action. It&#xD;
      possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions&#xD;
      as a 5-HT3 receptor antagonist, a Na channel blocker, and a mu-opioid agonist which may have&#xD;
      a potential role in decreasing pain. The study aimed to demonstrate the effectiveness of IP&#xD;
      administration of ondansetron on pain management post LC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">December 18, 2020</completion_date>
  <primary_completion_date type="Actual">December 18, 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in postoperative pain between the two groups using visual analogue score (VAS)</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Cholecystitis</condition>
  <arm_group>
    <arm_group_label>Ondansetron</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ondansetron intraperitoneal in the gall bladder bed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline intraperitoneal in the gall bladder bed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>Interperitoneal administration in the gall bladder bed</description>
    <arm_group_label>Ondansetron</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Interperitoneal administration in the gall bladder bed</description>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are scheduled to undergo elective LC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing chronic pain treatment&#xD;
&#xD;
          -  Previous allergic response to local anesthetics or 5-HT3 receptor antagonists&#xD;
&#xD;
          -  Patients who received analgesics or sedatives 24 h before scheduled surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The National Hepatology and Tropical Research medicine institute</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Hepatology &amp; Tropical Medicine Research Institute</investigator_affiliation>
    <investigator_full_name>Doaa abdelaziz</investigator_full_name>
    <investigator_title>Lecturer of clinical pharmacy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ondansetron</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/NCT04468685
org study id: 12-2020
nct id: NCT04468685
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal
      invasiveness, less post-operative pain and early recovery when compared to the open
      conventional cholecystectomy. However, patients who have undergone LC still complain of
      postoperative pain. It has been reported that ondansetron produces numbness when injected
      under the skin and has local anesthetic effect that is 15 times more potent than lidocaine
      the most widely used local anesthetic and probably explains its antiemetic action. It
      possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions
      as a 5-HT3 receptor antagonist, a Na channel blocker, and a mu-opioid agonist which may have
      a potential role in decreasing pain. The study aimed to demonstrate the effectiveness of IP
      administration of ondansetron on pain management post LC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: change in postoperative pain between the two groups using visual analogue score (VAS)
time frame: 24 hours
arm group label: Ondansetron
arm group type: Experimental
description: Ondansetron intraperitoneal in the gall bladder bed
arm group label: Saline
arm group type: Placebo Comparator
description: Normal saline intraperitoneal in the gall bladder bed
intervention type: Drug
intervention name: Ondansetron
description: Interperitoneal administration in the gall bladder bed
arm group label: Ondansetron
intervention type: Drug
intervention name: Normal saline
description: Interperitoneal administration in the gall bladder bed
arm group label: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: National Hepatology & Tropical Medicine Research Institute
investigator full name: Doaa abdelaziz
investigator title: Lecturer of clinical pharmacy
mesh term: Cholecystitis
mesh term: Ondansetron
sharing ipd: No