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/NCT06039150</url>
    </required_header>
    <id_info>
      <org_study_id>GULHANEELAERTEN</org_study_id>
      <nct_id>NCT06039150</nct_id>
    </id_info>
    <brief_title>Modified Thoracoabdominal Nerve Block(M-TAPA) in Pediatric Laparoscopic Appendectomies</brief_title>
    <acronym>M-TAPA</acronym>
    <official_title>Medical Doctor of Anesthesiology and Reanimation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gulhane Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gulhane Training and Research Hospital</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        To compare the effect of M-TAPA block and port-site local anesthetic infiltration on&#xD;
        postoperative pain in pediatric laparoscopic appendectomies. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
          -  Is M-TAPA block more effective in reducing pain?&#xD;
  &#xD;
          -  How M-TAPA block affects the use of rescue analgesics in the postoperative period?&#xD;
             Participants will have the same anaesthetic agents during surgery, before extubation&#xD;
             they will have same analgesic agent for postoperative pain. Participants in the M-TAPA&#xD;
             group will undergo USG-guided M-TAPA block bilaterally with % 0.025 Bupivacaine max dose&#xD;
             of 2 mg/kg by the same experienced anesthesiologist before extubation. Participants in&#xD;
             the LAI group will be administered 0.025% Bupivacaine at a maximum dose of 2mg/kg&#xD;
             divided equally and administered by the surgeon at 3 port entry sites before the patient&#xD;
             is extubated.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">December 21, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 21, 2023</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>Total number of rescue analgesic applications</measure>
      <time_frame>Postoperative first 24 hours</time_frame>
      <description>During the first 24 hours postoperatively, patients' pain will be monitored by Visual Analogue Scale (VAS) scoring. Paracetamol will be given intravenously at a dose of 10mg/kg if the VAS is greater than 4 in pain assessment in the postoperative period. We will record the number of times the patient received rescue analgesics over a 24-hour period.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Comparison of pain between 2 groups in the postoperative period</measure>
      <time_frame>Postoperative first 24 hours</time_frame>
      <description>The Visual Analogue Scale (VAS) scores were recorded postoperatively at 0 (PACU), 1, 4, 6, 12, and 24 h.&#xD;
  Visual Analogue Scale (VAS)&#xD;
  Scale vertical or horizontal from a 10 cm long line drawn as is formed. At the two ends of this line are the two end descriptor word (0 = &quot;no pain at all&quot;, 10 = worst/unbearable pain&quot;).The patient is asked to place a mark in the appropriate place for the intensity of the pain.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Comparison of postoperative complications</measure>
      <time_frame>Postoperative first 24 hours</time_frame>
      <description>Patients will be followed up for 24 hours postoperatively for complications including nausea and vomiting and shoulder pain. And it will be recorded.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Post Operative Pain</condition>
    <condition>Laparoscopic Surgery</condition>
    <condition>Pediatrics</condition>
    <condition>Regional Anesthesia</condition>
    <condition>Local Anesthetic</condition>
    <arm_group>
      <arm_group_label>M-TAPA group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The group to be administered 0.025% Bupivacaine by the anesthesiologist bilaterally in M-TAPA block with a maximum dose of 2 mg/kg before extubation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LAİ group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The group to be divided and administered 0.025% Bupivacaine with a maximum dose of 2 mg/kg by the surgeon to 3 port entry sites before extubation</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>M-TAPA Block</intervention_name>
      <description>M-TAPA Block; The block will be done by the same experienced anesthesiologist by using ultrasound(USG) after the surgical intervention is completed.The external oblique, internal oblique, and transversus abdominis muscles were shown on the costochondral angle in the sagittal plane at the 10th costal margin by using a high-frequency linear probe. Bilaterally in the midclavicular line at the level of the 10th rib (arcus costarum),0,5 ml/kg 0.25% Bupivacaine (maximum dose 2mg/kg) was administered to between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue.</description>
      <arm_group_label>M-TAPA group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Local anesthetic infltration to port sites</intervention_name>
      <description>Local anesthetic infiltration to port sites; The surgeon infiltrated 0.5 ml/kg of 0.25% Bupivacaine (maximum dose of 2mg/kg) in the skin, subcutaneous tissue, and muscle fascia at each of the three laparoscopic port areas at the end of the surgery.</description>
      <arm_group_label>LAİ group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with American society of Anesthesiologists (ASA) physical status I-II,&#xD;
  &#xD;
            -  Patients which will undergo Laparoscopic appendectomy due to the diagnosis of acute&#xD;
               appendicitis,&#xD;
  &#xD;
            -  Patients whose parents or legal heirs have consented to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with Society of Anesthesiologists (ASA) III-IV status,&#xD;
  &#xD;
            -  Patients whose parents or legal heirs' disapproval,&#xD;
  &#xD;
            -  Patients inability to cooperate,&#xD;
  &#xD;
            -  Patients who have allergy to any of the medications used in the study,&#xD;
  &#xD;
            -  Patients with perforated appendix&#xD;
  &#xD;
            -  When the Laparoscopic surgery returns to open shape&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ELA ERTEN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Anesthesiology and Reanimation department</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Gulhane Training and Research Hospital</name>
        <address>
          <city>Ankara</city>
          <state>Kecioren</state>
          <zip>06010</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.</citation>
      <PMID>21504934</PMID>
    </reference>
    <reference>
      <citation>Ozen V, Acik ME, Ozen N. The modified thoracoabdominal nerve block for post-operative analgesia in paediatric laparoscopic cholecystectomy. J Minim Access Surg. 2023 May 10. doi: 10.4103/jmas.jmas_174_22. Online ahead of print.</citation>
      <PMID>37282431</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gulhane Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>ELA ERTEN</investigator_full_name>
      <investigator_title>Medical Doctor</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>Anesthetics</mesh_term>
      <mesh_term>Anesthetics, Local</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06039150
  org study id: GULHANEELAERTEN
  nct id: NCT06039150
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To compare the effect of M-TAPA block and port-site local anesthetic infiltration on
        postoperative pain in pediatric laparoscopic appendectomies. The main questions it aims to
        answer are:
  
          -  Is M-TAPA block more effective in reducing pain?
  
          -  How M-TAPA block affects the use of rescue analgesics in the postoperative period?
             Participants will have the same anaesthetic agents during surgery, before extubation
             they will have same analgesic agent for postoperative pain. Participants in the M-TAPA
             group will undergo USG-guided M-TAPA block bilaterally with % 0.025 Bupivacaine max dose
             of 2 mg/kg by the same experienced anesthesiologist before extubation. Participants in
             the LAI group will be administered 0.025% Bupivacaine at a maximum dose of 2mg/kg
             divided equally and administered by the surgeon at 3 port entry sites before the patient
             is extubated.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Total number of rescue analgesic applications
  time frame: Postoperative first 24 hours
  description: During the first 24 hours postoperatively, patients' pain will be monitored by Visual Analogue Scale (VAS) scoring. Paracetamol will be given intravenously at a dose of 10mg/kg if the VAS is greater than 4 in pain assessment in the postoperative period. We will record the number of times the patient received rescue analgesics over a 24-hour period.
  measure: Comparison of pain between 2 groups in the postoperative period
  time frame: Postoperative first 24 hours
  description: The Visual Analogue Scale (VAS) scores were recorded postoperatively at 0 (PACU), 1, 4, 6, 12, and 24 h.
  Visual Analogue Scale (VAS)
  Scale vertical or horizontal from a 10 cm long line drawn as is formed. At the two ends of this line are the two end descriptor word (0 = "no pain at all", 10 = worst/unbearable pain").The patient is asked to place a mark in the appropriate place for the intensity of the pain.
  measure: Comparison of postoperative complications
  time frame: Postoperative first 24 hours
  description: Patients will be followed up for 24 hours postoperatively for complications including nausea and vomiting and shoulder pain. And it will be recorded.
  arm group label: M-TAPA group
  arm group type: Experimental
  description: The group to be administered 0.025% Bupivacaine by the anesthesiologist bilaterally in M-TAPA block with a maximum dose of 2 mg/kg before extubation.
  arm group label: LAİ group
  arm group type: Active Comparator
  description: The group to be divided and administered 0.025% Bupivacaine with a maximum dose of 2 mg/kg by the surgeon to 3 port entry sites before extubation
  intervention type: Procedure
  intervention name: M-TAPA Block
  description: M-TAPA Block; The block will be done by the same experienced anesthesiologist by using ultrasound(USG) after the surgical intervention is completed.The external oblique, internal oblique, and transversus abdominis muscles were shown on the costochondral angle in the sagittal plane at the 10th costal margin by using a high-frequency linear probe. Bilaterally in the midclavicular line at the level of the 10th rib (arcus costarum),0,5 ml/kg 0.25% Bupivacaine (maximum dose 2mg/kg) was administered to between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue.
  arm group label: M-TAPA group
  intervention type: Procedure
  intervention name: Local anesthetic infltration to port sites
  description: Local anesthetic infiltration to port sites; The surgeon infiltrated 0.5 ml/kg of 0.25% Bupivacaine (maximum dose of 2mg/kg) in the skin, subcutaneous tissue, and muscle fascia at each of the three laparoscopic port areas at the end of the surgery.
  arm group label: LAİ group
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: ELA ERTEN
  role: Principal Investigator
  affiliation: Anesthesiology and Reanimation department
  facility: 
  country: Turkey
  citation: Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.
  PMID: 21504934
  citation: Ozen V, Acik ME, Ozen N. The modified thoracoabdominal nerve block for post-operative analgesia in paediatric laparoscopic cholecystectomy. J Minim Access Surg. 2023 May 10. doi: 10.4103/jmas.jmas_174_22. Online ahead of print.
  PMID: 37282431
  responsible party type: Principal Investigator
  investigator affiliation: Gulhane Training and Research Hospital
  investigator full name: ELA ERTEN
  investigator title: Medical Doctor
  mesh term: Pain, Postoperative
  mesh term: Anesthetics
  mesh term: Anesthetics, Local
  sharing ipd: No