<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/NCT03799068</url>
  </required_header>
  <id_info>
    <org_study_id>Cleft Palate</org_study_id>
    <nct_id>NCT03799068</nct_id>
  </id_info>
  <brief_title>Suprazygomatic Nerve Block vs Surgical Site Infiltration in Cleft Palate Repair</brief_title>
  <official_title>Comparative Study of Bilateral Suprazygomatic Maxillary Nerve Block and Surgical Site Infiltration for Perioperative Analgesia in Children Undergoing Cleft Palate Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      The aim of this study is to evaluate the efficacy and duration of effect of bupivacaine given&#xD;
      preoperatively as a bilateral suprazygomatic maxillary nerve block and to compare it with&#xD;
      peri-incisional infiltration with the same agent for perioperative analgesia in children&#xD;
      undergoing cleft palate repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Congenital cleft palate (CP) occurs in children at a rate of about 1.5 per 10 000 births,&#xD;
      Early surgery is necessary to reduce phonation and feeding difficulties and reduce&#xD;
      complications such as frequent sinusitis and other respiratory tract infections. The surgical&#xD;
      procedure can be complicated by airway obstruction and respiratory complications. CP is&#xD;
      painful in the first 24-48 h following surgery.&#xD;
&#xD;
      Different treatment modalities have been used for reducing or ameliorating the pain following&#xD;
      cleft palate repair. These include opioids, paracetamol, non steroidal anti-inflammatory&#xD;
      drugs (NSAIDs), surgical site infiltration and various nerve blocks However, the analgesic&#xD;
      drugs may provide inadequate analgesia and have side effects such as respiratory depression&#xD;
      and bleeding. The inherent disadvantages of analgesic pharmacotherapy in children promoted&#xD;
      interest in nerve blocking techniques for operative analgesia. These became established in&#xD;
      paediatric anaesthetic practice with the accumulating evidence of advantages such as&#xD;
      postoperative pain relief, reduced use of potent narcotics, rapid return of alertness, early&#xD;
      feeding and moving about, and early discharge in day care surgery.&#xD;
&#xD;
      The maxillary nerve, the second division of the trigeminal nerve, leaves the cranial part of&#xD;
      the face through the foramen rotundum, and then passes forward and laterally through the&#xD;
      pterygopalatine fossa, at the bottom of the pterygomaxillary fossa, and reaches the floor of&#xD;
      the orbit by the infra- orbital foramen. This sensory nerve supplies innervation of the lower&#xD;
      eyelid, the upper lip, the skin between them, the roof of the mouth, and the palate.&#xD;
&#xD;
      Maxillary nerve block through the infrazygomatic route, used for the treatment of trigeminal&#xD;
      neuralgia in adults, permits anesthesia of the entire palatine territory. However, this nerve&#xD;
      block has lead to complications such as orbital puncture, intracranial injection, maxillary&#xD;
      artery puncture, or posterior pharyngeal wall injury In adults, approach to the&#xD;
      suprazygomatic MN block (SMB) seems to minimize the risks of the infrazygomatic route&#xD;
      providing effective anaesthesia of the entire sensory territory of the MN and its terminal&#xD;
      branches.&#xD;
&#xD;
      Bupivacaine, a long-acting amide local anaesthetic has been used widely in infants,&#xD;
      particularly for infiltration of wound-edges and nerve blocking.&#xD;
&#xD;
      Pre-incisional infiltration of local anaesthetics has been used both in adults and children&#xD;
      in a variety of surgeries with variable results. submucosal infiltration performed by the&#xD;
      surgeon seems to alter surgical conditions. Maxillary nerve block using the suprazygomatic&#xD;
      approach has demonstrated beneficial effects in adults for trigeminal neuralgia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>By Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) in Young Children (1-7 years) is a behavioral scale for evaluating postoperative pain in young children.&#xD;
Cry No crying +1 Moaning,crying +2 Screaming+3&#xD;
Facial expression: Smiling +1 Composed, neutral +2 Grimace +3&#xD;
Verbal responses Positive statements +1 Negative statement +2 Suffering from pain +3&#xD;
Torso Neutral/resting +1 Shifting, shivering, upright +2 Restrained +3&#xD;
Legs Neutral position+1 Squirming/kicking, drawn up, tensed legs +2 Restrained +3 Cheops score of 4 or less indicates no pain. Rescue analgesic consisting of paracetamol 10-15 mg/kg will be given rectally when CHEOPS is &gt; 4.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cleft Palate Children</condition>
  <condition>Block</condition>
  <arm_group>
    <arm_group_label>suprazygomatic maxillary nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the group were given a bilateral suprazygomatic maxillary nerve block with 0.125% bupivacaine, 2 ml on each side, the total dose of bupivacaine not exceeding 2 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgical site infiltraion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the group were given peri-incisional infiltration with 0.125% bupivacaine, 2 ml on each side. In all cases the block was given by the anaesthetist and the infiltration by the surgeon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>suprazygomatic maxillary nerve block</intervention_name>
    <description>bilateral Suprazygomatic maxillary nerve block is performed before surgery in anaesthetized children, after aseptic preparation of the skin. The patient is in supine position with the head in neutral position. The puncture site is at the frontozygomatic angle, at the junction of the upper edge of the zygomatic arch and the frontal process. A 24G needle is attached to a syringe containing the local anaesthetic. It is advanced to reach the greater wing of sphenoid at approximately 20 mm depth, then withdrawn a few millimetres and redirected toward the nasolabial fold in a 20° forward and 10° downward direction. The progression in the pterygopalatine fossa is 35 to 45 mm. Loss of resistance after passing through the temporalis muscle assisted in determining the puncture depth. After a negative blood aspiration test, the calculated dose of the local anaesthetic is injected on each side.</description>
    <arm_group_label>suprazygomatic maxillary nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>surgical site infiltration</intervention_name>
    <description>peri-incisional infiltration of bupivacaine around the incision site given by the surgeon on an anesthetized patient before the incision is done.</description>
    <arm_group_label>surgical site infiltraion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA grade I-III.&#xD;
&#xD;
          -  Aged from1-5 years&#xD;
&#xD;
          -  Undergoing cleft palate repair.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's refusal.&#xD;
&#xD;
          -  Allergy to local anaesthetics.&#xD;
&#xD;
          -  Trigeminal neuralgia.&#xD;
&#xD;
          -  Bleeding diathesis.&#xD;
&#xD;
          -  Inflammation or infection over injection site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut university hospital</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Maha Nasser Abdellatif Elshimy</investigator_full_name>
    <investigator_title>Clinical physician</investigator_title>
  </responsible_party>
  <keyword>bupivacaine</keyword>
  <keyword>suprazygomatic nerve block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Palate</mesh_term>
  </condition_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/NCT03799068
org study id: Cleft Palate
nct id: NCT03799068
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the efficacy and duration of effect of bupivacaine given
      preoperatively as a bilateral suprazygomatic maxillary nerve block and to compare it with
      peri-incisional infiltration with the same agent for perioperative analgesia in children
      undergoing cleft palate repair.
Congenital cleft palate (CP) occurs in children at a rate of about 1.5 per 10 000 births,
      Early surgery is necessary to reduce phonation and feeding difficulties and reduce
      complications such as frequent sinusitis and other respiratory tract infections. The surgical
      procedure can be complicated by airway obstruction and respiratory complications. CP is
      painful in the first 24-48 h following surgery.

      Different treatment modalities have been used for reducing or ameliorating the pain following
      cleft palate repair. These include opioids, paracetamol, non steroidal anti-inflammatory
      drugs (NSAIDs), surgical site infiltration and various nerve blocks However, the analgesic
      drugs may provide inadequate analgesia and have side effects such as respiratory depression
      and bleeding. The inherent disadvantages of analgesic pharmacotherapy in children promoted
      interest in nerve blocking techniques for operative analgesia. These became established in
      paediatric anaesthetic practice with the accumulating evidence of advantages such as
      postoperative pain relief, reduced use of potent narcotics, rapid return of alertness, early
      feeding and moving about, and early discharge in day care surgery.

      The maxillary nerve, the second division of the trigeminal nerve, leaves the cranial part of
      the face through the foramen rotundum, and then passes forward and laterally through the
      pterygopalatine fossa, at the bottom of the pterygomaxillary fossa, and reaches the floor of
      the orbit by the infra- orbital foramen. This sensory nerve supplies innervation of the lower
      eyelid, the upper lip, the skin between them, the roof of the mouth, and the palate.

      Maxillary nerve block through the infrazygomatic route, used for the treatment of trigeminal
      neuralgia in adults, permits anesthesia of the entire palatine territory. However, this nerve
      block has lead to complications such as orbital puncture, intracranial injection, maxillary
      artery puncture, or posterior pharyngeal wall injury In adults, approach to the
      suprazygomatic MN block (SMB) seems to minimize the risks of the infrazygomatic route
      providing effective anaesthesia of the entire sensory territory of the MN and its terminal
      branches.

      Bupivacaine, a long-acting amide local anaesthetic has been used widely in infants,
      particularly for infiltration of wound-edges and nerve blocking.

      Pre-incisional infiltration of local anaesthetics has been used both in adults and children
      in a variety of surgeries with variable results. submucosal infiltration performed by the
      surgeon seems to alter surgical conditions. Maxillary nerve block using the suprazygomatic
      approach has demonstrated beneficial effects in adults for trigeminal neuralgia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain assessment
time frame: 24 hours postoperative
description: By Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) in Young Children (1-7 years) is a behavioral scale for evaluating postoperative pain in young children.
Cry No crying +1 Moaning,crying +2 Screaming+3
Facial expression: Smiling +1 Composed, neutral +2 Grimace +3
Verbal responses Positive statements +1 Negative statement +2 Suffering from pain +3
Torso Neutral/resting +1 Shifting, shivering, upright +2 Restrained +3
Legs Neutral position+1 Squirming/kicking, drawn up, tensed legs +2 Restrained +3 Cheops score of 4 or less indicates no pain. Rescue analgesic consisting of paracetamol 10-15 mg/kg will be given rectally when CHEOPS is > 4.
arm group label: suprazygomatic maxillary nerve block
arm group type: Active Comparator
description: the group were given a bilateral suprazygomatic maxillary nerve block with 0.125% bupivacaine, 2 ml on each side, the total dose of bupivacaine not exceeding 2 mg/kg.
arm group label: surgical site infiltraion
arm group type: Active Comparator
description: the group were given peri-incisional infiltration with 0.125% bupivacaine, 2 ml on each side. In all cases the block was given by the anaesthetist and the infiltration by the surgeon.
intervention type: Other
intervention name: suprazygomatic maxillary nerve block
description: bilateral Suprazygomatic maxillary nerve block is performed before surgery in anaesthetized children, after aseptic preparation of the skin. The patient is in supine position with the head in neutral position. The puncture site is at the frontozygomatic angle, at the junction of the upper edge of the zygomatic arch and the frontal process. A 24G needle is attached to a syringe containing the local anaesthetic. It is advanced to reach the greater wing of sphenoid at approximately 20 mm depth, then withdrawn a few millimetres and redirected toward the nasolabial fold in a 20° forward and 10° downward direction. The progression in the pterygopalatine fossa is 35 to 45 mm. Loss of resistance after passing through the temporalis muscle assisted in determining the puncture depth. After a negative blood aspiration test, the calculated dose of the local anaesthetic is injected on each side.
arm group label: suprazygomatic maxillary nerve block
intervention type: Other
intervention name: surgical site infiltration
description: peri-incisional infiltration of bupivacaine around the incision site given by the surgeon on an anesthetized patient before the incision is done.
arm group label: surgical site infiltraion
criteria: 
gender: All
minimum age: 1 Year
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Maha Nasser Abdellatif Elshimy
investigator title: Clinical physician
mesh term: Cleft Palate
sharing ipd: No