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/NCT05999734</url>
    </required_header>
    <id_info>
      <org_study_id>MTP block</org_study_id>
      <nct_id>NCT05999734</nct_id>
    </id_info>
    <brief_title>Mid-transverse Process to Pleura Block in Pediatric Thoracotomy</brief_title>
    <official_title>Ultrasound-Guided Mid-Transverse Process to Pleura Block for Analgesia in Pediatric Thoracotomy: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The aim of this study is to assess the effectiveness of analgesia of US guided MTP block in&#xD;
        pediatrics undergoing thoracotomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pain following surgery is a universal phenomenon which up to now is often underestimated and&#xD;
        undertreated especially in pediatrics. Any postoperative analgesic technique should meet&#xD;
        three criteria, which are effectiveness, universal applicability and safety.&#xD;
  &#xD;
        Thoracotomy is widely known to cause severe acute pain. This pain can be very distressing for&#xD;
        both children and their parents. If not treated properly, it may acutely cause&#xD;
        ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics. It&#xD;
        may lead to a delay in recovery, with some long-term sequelae. As a part of multimodal&#xD;
        analgesia, many regional blocks have been described.&#xD;
  &#xD;
        Regional anesthesia techniques are increasingly used in all surgical settings. Even in the&#xD;
        context of thoracic surgery, new peripheral regional anesthesia techniques are being tested&#xD;
        as alternatives to those already used. This proliferation of new techniques is explained, on&#xD;
        the one hand, by the evolution of surgical techniques, which are becoming less and less&#xD;
        invasive, and on the other hand, by the frequency and severity of the complications induced&#xD;
        by thoracic epidural anesthesia and paravertebral block - currently the gold standards in&#xD;
        context of pediatric setting.&#xD;
  &#xD;
        Paravertebral block (PVB) has gained more popularity than other regional analgesic techniques&#xD;
        including epidural for perioperative analgesia in pediatric surgery. Thoracic PVB provides&#xD;
        adequate postoperative analgesia with favorable adverse effects. The use of thoracic PVB is&#xD;
        associated with decreased pain severity and opioid consumption in both adults and children.&#xD;
  &#xD;
        Many clinicians hesitate to apply the PVB technique due to the risk of serious complications&#xD;
        such as pneumothorax. Therefore, the safest and most effective methods are being tried by&#xD;
        clinicians. In a study conducted on cadavers claimed that mid-transverse process to pleura&#xD;
        (MTP) block (an injection point midway between the pleura and posterior border of the&#xD;
        transverse process) provides a paravertebral block due to the paravertebral spread of the&#xD;
        local anesthetic agent through fenestrations and septations in the superior costotransverse&#xD;
        ligament. They thought that MTP block may be as effective as PVB in postoperative pain&#xD;
        management with less risk of possible complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">August 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, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The total dose of morphine consumption in the first postoperative 24 hours.</measure>
      <time_frame>24 hours postoperative</time_frame>
      <description>The total dose of morphine consumption in the first postoperative 24 hours.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain will be assessed by the face, legs, activity, cry and consolability (FLACC) score in children at 1, 2, 6, 12, 18 and 24 hours postoperative.</measure>
      <time_frame>1, 2, 6, 12, 18 and 24 hours postoperative.</time_frame>
      <description>Pain will be assessed by the face, legs, activity, cry and consolability (FLACC) score in children at 1, 2, 6, 12, 18 and 24 hours postoperative.The scale is scored in a range of 0 to 10 with 0 representing no pain, 10 representing the maxim</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery.</measure>
      <time_frame>from induction of anesthesia till the end of surgery.</time_frame>
      <description>Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).</measure>
      <time_frame>Immediately 15 minutes preoperative and 15 minutes postoperative</time_frame>
      <description>Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Ultrasound Guided Block</condition>
    <condition>Pediatric Surgery</condition>
    <condition>Analgesia</condition>
    <arm_group>
      <arm_group_label>Patients undergoing pediatric thoracotomy will receive general anesthesia alone.</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>the patients will receive general anesthesia alone. Anesthesia will be induced by inhalation of sevoflurane at 8% concentration which will decreased gradually down to 2% concentration carried by 100% oxygen, with loss of consciousness; a peripheral intra venous cannula with suitable size will be inserted, then the neuromuscular blockade will be facilitated by cisatracurium 0.15 mg/ kg to allow tracheal intubation with appropriate sized endotracheal tube. Fentanyl 1μg/ kg will be given and anesthesia will be maintained with air and O2 (50:50) and along with 2% end tidal concentration of sevoflurane to control the depth of anesthesia. At the end of surgery residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>general anesthesia and ultrasound guided MTP block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>midpoint between the transverse process and the pleura 0.5mL/kg 0.25% bupivacaine will be injected.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine</intervention_name>
      <description>Before skin incision, under complete aseptic precautions and sterilization, the patient will be placed in a lateral position. The spinous process of the fourth thoracic vertebra will be identified and marked. The ultrasound guided MTP block will be done by high frequency linear transducer will be placed in position just lateral to the spinous processes of thoracic vertebra target of the paravertebral space. A 50 mm 22-gauge echogenic needle will be inserted in an in plane technique from a caudal to a cephalad direction and will be advanced. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline will be injected. Once the needle tip has been confirmed and after careful aspiration to demonstrate the absence of air or blood, 0.5mL/kg 0.25% bupivacaine will be injected.</description>
      <arm_group_label>general anesthesia and ultrasound guided MTP block</arm_group_label>
      <other_name>Mid transverse process to pleural block</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The study will include 50 pediatric patients of both sexes aged from 5 to 15 years old&#xD;
               with American Society of Anesthesiologists physical status I&amp; II undergoing elective&#xD;
               open thoracotomy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of parents.&#xD;
  &#xD;
            -  Repeated thoracotomy.&#xD;
  &#xD;
            -  Emergency surgery.&#xD;
  &#xD;
            -  Mechanically ventilated patients.&#xD;
  &#xD;
            -  Bleeding disorders.&#xD;
  &#xD;
            -  Allergy to study drugs.&#xD;
  &#xD;
            -  Infection at the site of the needle puncture.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Heba Gawish, Master</last_name>
      <phone>01069914549</phone>
      <email>Hebasalah78100@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mohammed Shebl Abdelghany, MD</last_name>
      <phone>+20 106 334 5623</phone>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Heba Salah Eldin Gawish</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <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>
  
  
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/NCT05999734
  org study id: MTP block
  nct id: NCT05999734
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to assess the effectiveness of analgesia of US guided MTP block in
        pediatrics undergoing thoracotomy.
  Pain following surgery is a universal phenomenon which up to now is often underestimated and
        undertreated especially in pediatrics. Any postoperative analgesic technique should meet
        three criteria, which are effectiveness, universal applicability and safety.
  
        Thoracotomy is widely known to cause severe acute pain. This pain can be very distressing for
        both children and their parents. If not treated properly, it may acutely cause
        ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics. It
        may lead to a delay in recovery, with some long-term sequelae. As a part of multimodal
        analgesia, many regional blocks have been described.
  
        Regional anesthesia techniques are increasingly used in all surgical settings. Even in the
        context of thoracic surgery, new peripheral regional anesthesia techniques are being tested
        as alternatives to those already used. This proliferation of new techniques is explained, on
        the one hand, by the evolution of surgical techniques, which are becoming less and less
        invasive, and on the other hand, by the frequency and severity of the complications induced
        by thoracic epidural anesthesia and paravertebral block - currently the gold standards in
        context of pediatric setting.
  
        Paravertebral block (PVB) has gained more popularity than other regional analgesic techniques
        including epidural for perioperative analgesia in pediatric surgery. Thoracic PVB provides
        adequate postoperative analgesia with favorable adverse effects. The use of thoracic PVB is
        associated with decreased pain severity and opioid consumption in both adults and children.
  
        Many clinicians hesitate to apply the PVB technique due to the risk of serious complications
        such as pneumothorax. Therefore, the safest and most effective methods are being tried by
        clinicians. In a study conducted on cadavers claimed that mid-transverse process to pleura
        (MTP) block (an injection point midway between the pleura and posterior border of the
        transverse process) provides a paravertebral block due to the paravertebral spread of the
        local anesthetic agent through fenestrations and septations in the superior costotransverse
        ligament. They thought that MTP block may be as effective as PVB in postoperative pain
        management with less risk of possible complications.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: The total dose of morphine consumption in the first postoperative 24 hours.
  time frame: 24 hours postoperative
  description: The total dose of morphine consumption in the first postoperative 24 hours.
  measure: Pain will be assessed by the face, legs, activity, cry and consolability (FLACC) score in children at 1, 2, 6, 12, 18 and 24 hours postoperative.
  time frame: 1, 2, 6, 12, 18 and 24 hours postoperative.
  description: Pain will be assessed by the face, legs, activity, cry and consolability (FLACC) score in children at 1, 2, 6, 12, 18 and 24 hours postoperative.The scale is scored in a range of 0 to 10 with 0 representing no pain, 10 representing the maxim
  measure: Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery.
  time frame: from induction of anesthesia till the end of surgery.
  description: Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery.
  measure: Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).
  time frame: Immediately 15 minutes preoperative and 15 minutes postoperative
  description: Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).
  arm group label: Patients undergoing pediatric thoracotomy will receive general anesthesia alone.
  arm group type: No Intervention
  description: the patients will receive general anesthesia alone. Anesthesia will be induced by inhalation of sevoflurane at 8% concentration which will decreased gradually down to 2% concentration carried by 100% oxygen, with loss of consciousness; a peripheral intra venous cannula with suitable size will be inserted, then the neuromuscular blockade will be facilitated by cisatracurium 0.15 mg/ kg to allow tracheal intubation with appropriate sized endotracheal tube. Fentanyl 1μg/ kg will be given and anesthesia will be maintained with air and O2 (50:50) and along with 2% end tidal concentration of sevoflurane to control the depth of anesthesia. At the end of surgery residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.
  arm group label: general anesthesia and ultrasound guided MTP block
  arm group type: Active Comparator
  description: midpoint between the transverse process and the pleura 0.5mL/kg 0.25% bupivacaine will be injected.
  intervention type: Drug
  intervention name: Bupivacaine
  description: Before skin incision, under complete aseptic precautions and sterilization, the patient will be placed in a lateral position. The spinous process of the fourth thoracic vertebra will be identified and marked. The ultrasound guided MTP block will be done by high frequency linear transducer will be placed in position just lateral to the spinous processes of thoracic vertebra target of the paravertebral space. A 50 mm 22-gauge echogenic needle will be inserted in an in plane technique from a caudal to a cephalad direction and will be advanced. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline will be injected. Once the needle tip has been confirmed and after careful aspiration to demonstrate the absence of air or blood, 0.5mL/kg 0.25% bupivacaine will be injected.
  arm group label: general anesthesia and ultrasound guided MTP block
  other name: Mid transverse process to pleural block
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 15 Years
  healthy volunteers: No
  last name: Heba Gawish, Master
  phone: 01069914549
  email: Hebasalah78100@gmail.com
  last name: Mohammed Shebl Abdelghany, MD
  phone: +20 106 334 5623
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Heba Salah Eldin Gawish
  investigator title: Principal investigator
  mesh term: Bupivacaine
  sharing ipd: No