<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/NCT04467463</url>
  </required_header>
  <id_info>
    <org_study_id>N-98-2019</org_study_id>
    <nct_id>NCT04467463</nct_id>
  </id_info>
  <brief_title>Peripheral Nerve Block Techniques During Cleft Palate</brief_title>
  <official_title>Comparing Two Peripheral Nerve Block Techniques for Perioperative Analgesia During Cleft Palate Surgery in Pediatric Patients: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative&#xD;
      analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN)&#xD;
      are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this&#xD;
      study was to compare the analgesic effect as well as the incidence of complications&#xD;
      associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing&#xD;
      palatoplasty surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>
    <intervention_model_description>The two study groups were:&#xD;
Group GPN, 20 patients received bilateral greater palatine nerve block.&#xD;
Group SMN, 20 patients received bilateral suprazygomatic maxillary nerve block.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>masking from the aim of the study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain score</measure>
    <time_frame>the first 12 postoperative hours</time_frame>
    <description>Pain assessment was done immediately postoperative using Objective behavioral pain score</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>GPN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administrated bilateral greater palatine nerve block using levobupivacaine 0.25%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>peripheral nerve block by 0.25% levobupivacaine</intervention_name>
    <description>SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.</description>
    <arm_group_label>GPN</arm_group_label>
    <arm_group_label>SMN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-III scheduled to undergo palatoplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bleeding disorders,&#xD;
&#xD;
          -  skin lesions or wounds at site of proposed needle insertion,&#xD;
&#xD;
          -  congenital heart disease,&#xD;
&#xD;
          -  respiratory or&#xD;
&#xD;
          -  cardiovascular disorders,&#xD;
&#xD;
          -  children scheduled for combined procedures like palatoplasty with cheiloplasty or&#xD;
             submucosal alveolar bone grafting,&#xD;
&#xD;
          -  known hypersensitivity to local anesthetics or opioids and&#xD;
&#xD;
          -  lack of parental consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sherif Abdullah Mohamed, M.D.</last_name>
    <phone>+201002013497</phone>
    <phone_ext>02</phone_ext>
    <email>dr.sherif213@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University hospitals</name>
      <address>
        <city>Cairo</city>
        <state>Manial</state>
        <zip>12511</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ayman Hussam, M.D.</last_name>
      <phone>01004389020</phone>
      <email>Ahhussam@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>anesthesia department at Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.</citation>
    <PMID>460932</PMID>
  </reference>
  <reference>
    <citation>Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947.</citation>
    <PMID>16118385</PMID>
  </reference>
  <reference>
    <citation>3. Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.</citation>
  </reference>
  <reference>
    <citation>Diewert VM. Development of human craniofacial morphology during the late embryonic and early fetal periods. Am J Orthod. 1985 Jul;88(1):64-76. doi: 10.1016/0002-9416(85)90107-1.</citation>
    <PMID>3860013</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>October 27, 2020</last_update_submitted>
  <last_update_submitted_qc>October 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed Elsonbaty</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Suprazygomatic</keyword>
  <keyword>Maxillary</keyword>
  <keyword>Palatine</keyword>
  <keyword>Cleft Palate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Palate</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levobupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>not to share</ipd_description>
  </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/NCT04467463
org study id: N-98-2019
nct id: NCT04467463
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative
      analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN)
      are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this
      study was to compare the analgesic effect as well as the incidence of complications
      associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing
      palatoplasty surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The two study groups were:
Group GPN, 20 patients received bilateral greater palatine nerve block.
Group SMN, 20 patients received bilateral suprazygomatic maxillary nerve block.
primary purpose: Prevention
masking: Single (Care Provider)
masking description: masking from the aim of the study
measure: postoperative pain score
time frame: the first 12 postoperative hours
description: Pain assessment was done immediately postoperative using Objective behavioral pain score
arm group label: GPN
arm group type: Experimental
description: administrated bilateral greater palatine nerve block using levobupivacaine 0.25%
arm group label: SMN
arm group type: Experimental
description: administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%.
intervention type: Procedure
intervention name: peripheral nerve block by 0.25% levobupivacaine
description: SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.
arm group label: GPN
arm group label: SMN
criteria: 
gender: All
minimum age: 6 Months
maximum age: 5 Years
healthy volunteers: No
last name: Sherif Abdullah Mohamed, M.D.
phone: +201002013497
phone ext: 02
email: dr.sherif213@yahoo.com
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
country: Egypt
citation: Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.
PMID: 460932
citation: Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947.
PMID: 16118385
citation: 3. Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
citation: Diewert VM. Development of human craniofacial morphology during the late embryonic and early fetal periods. Am J Orthod. 1985 Jul;88(1):64-76. doi: 10.1016/0002-9416(85)90107-1.
PMID: 3860013
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed Elsonbaty
investigator title: Principal Investigator
mesh term: Cleft Palate
mesh term: Levobupivacaine
sharing ipd: No
ipd description: not to share