xml: <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/NCT06007378</url>
    </required_header>
    <id_info>
      <org_study_id>FMASU MS 416 / 2023</org_study_id>
      <nct_id>NCT06007378</nct_id>
    </id_info>
    <brief_title>Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery</brief_title>
    <official_title>Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery by Supplementing Ultrasound-guided Erector Spinae Plane Block With Ketamine or Transdermal Fentanyl Patch</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Erector spinae plane block (ESPB) is a novel regional block technique that was proven to have&#xD;
        superior outcomes in relieving postoperative pain in colorectal surgeries.Ketamine enhances&#xD;
        the impact of local anaesthetics by reducing the duration and extent of motor block while&#xD;
        shortening the onset of sensory and motor block.Transdermal Fentanyl Patch (TFP) was better&#xD;
        than transdermal buprenorphine in postoperative analgesia following abdominal surgeries.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>Prevention</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The total rescue analgesia consumption (mg)</measure>
      <time_frame>in the first 48 hours after surgery</time_frame>
      <description>The total rescue analgesia consumption (mg) in the first 48 hours after surgery</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>Bupivacaine and ketamine</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Bupivacaine and transdermal fentanyl patch</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Bupivacaine</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Bupivacaine and ketamine</intervention_name>
      <description>Bilateral erector spinae plane block (bupivacaine and ketamine)</description>
      <arm_group_label>Bupivacaine and ketamine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Bupivacaine and transdermal fentanyl patch</intervention_name>
      <description>Bilateral erector spinae plane block (bupivacaine) and transdermal fentanyl patch</description>
      <arm_group_label>Bupivacaine and transdermal fentanyl patch</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Bupivacain</intervention_name>
      <description>Bilateral erector spinae plane block (bupivacaine)</description>
      <arm_group_label>Bupivacaine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing laparoscopic colorectal surgery.&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) physical status I or II.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known allergy to one of the study medications.&#xD;
  &#xD;
            -  Skin infections at the site of the needle puncture.&#xD;
  &#xD;
            -  Hepatic, renal or cardiac dysfunction.&#xD;
  &#xD;
            -  Patients diagnosed with obstructive sleep apnoea&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ibrahim Mamdouh Esmat</last_name>
      <phone>01001241928</phone>
      <email>ibrahim_mamdouh@med.asu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ain-Shams University Hospitals</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Ibrahim Mamdouh Esmat</last_name>
        <phone>01001241928</phone>
        <email>ibrahim_mamdouh@med.asu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Dr.Ibrahim Mamdouh Esmat</investigator_full_name>
      <investigator_title>Assistant Professor of Anesthesia and Intensive Care, Faculty of Medicine, Ain- shams University, Cairo, Egypt.</investigator_title>
    </responsible_party>
    <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>Fentanyl</mesh_term>
      <mesh_term>Ketamine</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007378
  org study id: FMASU MS 416 / 2023
  nct id: NCT06007378
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Erector spinae plane block (ESPB) is a novel regional block technique that was proven to have
        superior outcomes in relieving postoperative pain in colorectal surgeries.Ketamine enhances
        the impact of local anaesthetics by reducing the duration and extent of motor block while
        shortening the onset of sensory and motor block.Transdermal Fentanyl Patch (TFP) was better
        than transdermal buprenorphine in postoperative analgesia following abdominal surgeries.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Care Provider)
  measure: The total rescue analgesia consumption (mg)
  time frame: in the first 48 hours after surgery
  description: The total rescue analgesia consumption (mg) in the first 48 hours after surgery
  arm group label: Bupivacaine and ketamine
  arm group type: Other
  arm group label: Bupivacaine and transdermal fentanyl patch
  arm group type: Other
  arm group label: Bupivacaine
  arm group type: Other
  intervention type: Other
  intervention name: Bupivacaine and ketamine
  description: Bilateral erector spinae plane block (bupivacaine and ketamine)
  arm group label: Bupivacaine and ketamine
  intervention type: Other
  intervention name: Bupivacaine and transdermal fentanyl patch
  description: Bilateral erector spinae plane block (bupivacaine) and transdermal fentanyl patch
  arm group label: Bupivacaine and transdermal fentanyl patch
  intervention type: Other
  intervention name: Bupivacain
  description: Bilateral erector spinae plane block (bupivacaine)
  arm group label: Bupivacaine
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ibrahim Mamdouh Esmat
  phone: 01001241928
  email: ibrahim_mamdouh@med.asu.edu.eg
  facility: 
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Dr.Ibrahim Mamdouh Esmat
  investigator title: Assistant Professor of Anesthesia and Intensive Care, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
  mesh term: Pain, Postoperative
  mesh term: Fentanyl
  mesh term: Ketamine
  mesh term: Bupivacaine