<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/NCT03762343</url>
  </required_header>
  <id_info>
    <org_study_id>N-11/s /2015/MD</org_study_id>
    <nct_id>NCT03762343</nct_id>
  </id_info>
  <brief_title>Ultrasound-guided Greater Occipital Nerve Block in Children Undergoing Posterior Fossa Craniotomy</brief_title>
  <official_title>Ultrasound-guided Greater Occipital Nerve Block in Children Undergoing Posterior Fossa Craniotomy: Randomized, Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgery within the posterior fossa is associated with the highest incidence and greatest&#xD;
      severity of acute postoperative pain that may persist beyond the immediate postoperative&#xD;
      period.&#xD;
&#xD;
      The utilization of local nerve blocks of the scalp in children may provide analgesia with&#xD;
      stable hemodynamics while reducing the need for other anesthetics such as inhaled anesthetics&#xD;
      and opioids. This could in turn result in less side effects, higher patient and family&#xD;
      satisfaction, and better outcomes.&#xD;
&#xD;
      The use of ultrasound-guided greater occipital nerve block (GONB) for perioperative pain&#xD;
      management of posterior fossa surgery in pediatrics is not previously reported.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgery within the posterior fossa is associated with the highest incidence and greatest&#xD;
      severity of acute postoperative pain that may persist beyond the immediate postoperative&#xD;
      period.&#xD;
&#xD;
      Despite a greater awareness of pain after all types of intracranial surgery, clinicians&#xD;
      remain reluctant to administer opioids to patients undergoing intracranial surgery because&#xD;
      the opioid side effects that may mask signs of neurologic decompensation.&#xD;
&#xD;
      Furthermore, opioids can depress minute ventilation, leading to hypercapnia and increased&#xD;
      intracranial pressures. These concerns may be of greater relevance for surgery of the&#xD;
      posteriorfossa. However, untreated, pain can also be detrimental. Patients in pain may appear&#xD;
      agitated, uncooperative, and experience longer-term pain-related sequelae.&#xD;
&#xD;
      The utilization of local nerve blocks of the scalp in children may thus provide analgesia&#xD;
      with stable hemodynamics while reducing the need for other anesthetics such as inhaled&#xD;
      anesthetics and opioids: this could in turn result in less side effects, higher patient and&#xD;
      family satisfaction, and better outcomes.&#xD;
&#xD;
      The use of ultrasound-guided greater occipital nerve block (GONB) for perioperative pain&#xD;
      management of posterior fossa surgery in pediatrics is not previously reported.&#xD;
&#xD;
      The authors hypothesize that ultrasound-guided greater occipital nerve block (GONB) for&#xD;
      perioperative pain management of posterior fossa is feasible and superior to conventional&#xD;
      methods for perioperative pain management.&#xD;
&#xD;
      After institutional research ethics committee approval, 40 children aged (2-10 years), ASA&#xD;
      physical status I or II, Glasgow Coma Scale (GCS) 15, scheduled for craniotomy for posterior&#xD;
      fossa tumors will be recruited and a written informed consent will be obtained from the&#xD;
      patient guardians.&#xD;
&#xD;
      Anesthetic management:&#xD;
&#xD;
      Patients will not receive any premedication. Upon arrival to the operating room heart rate,&#xD;
      noninvasive blood pressure NBP and oxygen saturation SPO2 will be monitored using standard&#xD;
      monitor (drȁger infinity vista XL) before inhalational induction of anesthesia using&#xD;
      sevoflurane titration (2-8%). 20 or 22 G canula will be inserted after the patient is put to&#xD;
      sleep. Anesthesia will be completed by fentanyl (2µg/kg) and atracurium 0.5mg/kg. if IV&#xD;
      canula is present anesthesia will be induced by propofol (1-2 mg/kg), fentanyl (2µg/kg) and&#xD;
      atracurium 0.5mg/kg After tracheal intubation anesthesia will be maintained using isoflurane&#xD;
      1% in oxygen and air (FIO2 0.6), atracurium infusion at a rate of 0.5 mg/kg/h. Controlled&#xD;
      ventilation will be adjusted to maintain moderate hyperventilation (end tidal CO2 30-35&#xD;
      mmHg). A core temperature will be measured using nasopharyngeal probe and a Foley's catheter&#xD;
      will be inserted in the urinary bladder. 22G radial arterial canula will be inserted for&#xD;
      invasive blood pressure monitoring and blood sampling and central venous line (CVP) will be&#xD;
      inserted under complete aseptic condition with ultrasound guidance and wide bore peripheral&#xD;
      canula for fluid management.&#xD;
&#xD;
      Greater occipital nerve block:&#xD;
&#xD;
      After the patient is positioned in the prone position with mild neck flexion and after&#xD;
      disinfection of the skin; the GON will be located in the short axis plane using the (M-Turbo&#xD;
      TM) ultrasound system with a 6-13 MHz high-resolution linear ultrasound transducer (Sonosite,&#xD;
      USA).&#xD;
&#xD;
      The ultrasound probe will be placed in a transverse plane over the classical block site, at&#xD;
      the level of the superior nuchal line, with the center of the probe at about 2-3 cm lateral&#xD;
      to the external occipital protuberance. The GON will be identified in the short axis plane,&#xD;
      Then, under real-time scanning, A 22 G canula will be advanced guided with ultrasound using&#xD;
      an in-plane (IP) technique from lateral to medial to position the tip of the canula exactly&#xD;
      at the center of the nerve. Thereafter, 2 ml of bupivacaine 0.5% will be injected to block&#xD;
      the nerve. This technique will then be repeated on the other side.&#xD;
&#xD;
      Vital signs (heart rate, arterial blood pressure, and SpO2) will be monitored continuously&#xD;
      And recorded every 30 minutes intraoperatively, and at 2, 4, 6, 8, 12, 16, and 24 hours&#xD;
      postoperatively. Bradycardia (heart rate less than 60 beats/minute) will be treated with&#xD;
      atropine (0.02mg/kg IV). Fentanyl 0.5 µg /kg as rescue analgesia will be given if HR and&#xD;
      systolic BP increased &gt;20% of base line up to maximum 5 µg/ kg. 15 mg/kg of IV paracetamol&#xD;
      will be given at the beginning of dural closure at the end of the procedure for both groups.&#xD;
&#xD;
      Postoperative assessment and analgesic regimen:&#xD;
&#xD;
      Objective Pain Scale (OPS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours&#xD;
      postoperatively. The time to the first request of rescue postoperative analgesic will be:&#xD;
      &quot;the time interval between the onset of GONB and the first request to postoperative analgesia&#xD;
      and or OPS score ˃2-3&quot;. When patients first complain of pain (OPS score ˃2-3) an intravenous&#xD;
      paracetamol 15mg/kg will be given and will be repeated every 6 hours. Persistent or&#xD;
      breakthrough pain will be managed with incremental intravenous morphine at a dose of&#xD;
      0.05mg/kg to maintain resting OPS at &lt; 2-3. Cumulative 24 hours analgesic consumption will be&#xD;
      recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into two study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator performing the block and assessing study outcomes will all be blinded to the study group allocation. The intraoperative study outcomes will be assessed by an anesthetist who is not involved in the block performance and postoperative data will be collected by PICU trained nurses who are blinded to the study groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Pain Scale (OPS) at 12 hours postoperative.</measure>
    <time_frame>at 12 hours postoperative</time_frame>
    <description>the score has five items(systolic blood pressure, crying, movement,agitation and complain of pain) with a minimum of zero and a maximum of 2 for each item.&#xD;
total score = SUM of all points for all parameters&#xD;
Minimum score: 0&#xD;
Maximum score: 10&#xD;
Maximum score if too young to complain of pain: 8 if the score is used with 5 items, a score exceeding the number 3 requires therapeutically effective analgesic. if the score is used with its 4 items, a score exceeding the number 2 requires therapeutic effective analgesic.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first request of postoperative rescue analgesics</measure>
    <time_frame>within 24 hours</time_frame>
    <description>the time interval between the onset of GONB and the first request to postoperative analgesia and or OPS score ˃2- 3&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Pain Scale (OPS) up to 24 hours.</measure>
    <time_frame>at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively</time_frame>
    <description>the score has five items(systolic blood pressure, crying, movement,agitation and complain of pain) with a minimum of zero and a maximum of 2 for each item.&#xD;
total score = SUM of all points for all parameters&#xD;
Minimum score: 0&#xD;
Maximum score: 10&#xD;
Maximum score if too young to complain of pain: 8 if the score is used with 5 items, a score exceeding the number 3 requires therapeutically effective analgesic. if the score is used with its 4 items, a score exceeding the number 2 requires therapeutic effective analgesic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative hemodynamic parameters</measure>
    <time_frame>every 30 minutes intraoperative and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively</time_frame>
    <description>Heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>within 24 hours</time_frame>
    <description>number of patients who develop scalp hematoma in the GONB group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>within 24 hours</time_frame>
    <description>number of patients who develop postoperative nausea and vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative hemodynamic parameters</measure>
    <time_frame>every 30 minutes intraoperative and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively</time_frame>
    <description>systolic and diastolic arterial blood pressure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Posterior Fossa Tumor</condition>
  <arm_group>
    <arm_group_label>Greater occipital nerve block group (group GONB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient in this group will receive 2 ml of bupivacaine 0.5% (up to a maximum of 2 mg/kg) subcutaneous under ultrasound guidance in the greater occipital nerve region bilaterally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group (group C):</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient in this group will receive the intraoperative standard of care(intraoperative intravenous fentanyl and paracetamol)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ultrasound guided Greater occipital nerve block</intervention_name>
    <description>ultrasound guided Greater occipital nerve block with 2 ml of bupivacaine 0.5% (up to a maximum of 2 mg/kg) subcutaneous under ultrasound guidance in the greater occipital nerve region bilaterally.</description>
    <arm_group_label>Greater occipital nerve block group (group GONB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>control group C</intervention_name>
    <description>Patient in this group will receive the intraoperative standard of care(intraoperative intravenous fentanyl and paracetamol)</description>
    <arm_group_label>Control group (group C):</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status I or II,&#xD;
&#xD;
          -  Glasgow Coma Scale (GCS) 15,&#xD;
&#xD;
          -  children scheduled for craniotomy for posterior fossa tumors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of patients guardians&#xD;
&#xD;
          -  Patients with suspected or proved allergic to local anesthetics&#xD;
&#xD;
          -  Emergency surgery,&#xD;
&#xD;
          -  Children with GCS &lt; 15&#xD;
&#xD;
          -  Craniotomy incision beyond the coverage of the block will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>August 11, 2022</last_update_submitted>
  <last_update_submitted_qc>August 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Khaled Abdelfattah Abdallah Sarhan</investigator_full_name>
    <investigator_title>lecturer of anesthesia, SICU and pain management</investigator_title>
  </responsible_party>
  <keyword>greater occipital nerve block</keyword>
  <keyword>posterior fossa</keyword>
  <keyword>ultrasound</keyword>
  <keyword>pain</keyword>
  <keyword>craniotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infratentorial Neoplasms</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/NCT03762343
org study id: N-11/s /2015/MD
nct id: NCT03762343
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Surgery within the posterior fossa is associated with the highest incidence and greatest
      severity of acute postoperative pain that may persist beyond the immediate postoperative
      period.

      The utilization of local nerve blocks of the scalp in children may provide analgesia with
      stable hemodynamics while reducing the need for other anesthetics such as inhaled anesthetics
      and opioids. This could in turn result in less side effects, higher patient and family
      satisfaction, and better outcomes.

      The use of ultrasound-guided greater occipital nerve block (GONB) for perioperative pain
      management of posterior fossa surgery in pediatrics is not previously reported.
Surgery within the posterior fossa is associated with the highest incidence and greatest
      severity of acute postoperative pain that may persist beyond the immediate postoperative
      period.

      Despite a greater awareness of pain after all types of intracranial surgery, clinicians
      remain reluctant to administer opioids to patients undergoing intracranial surgery because
      the opioid side effects that may mask signs of neurologic decompensation.

      Furthermore, opioids can depress minute ventilation, leading to hypercapnia and increased
      intracranial pressures. These concerns may be of greater relevance for surgery of the
      posteriorfossa. However, untreated, pain can also be detrimental. Patients in pain may appear
      agitated, uncooperative, and experience longer-term pain-related sequelae.

      The utilization of local nerve blocks of the scalp in children may thus provide analgesia
      with stable hemodynamics while reducing the need for other anesthetics such as inhaled
      anesthetics and opioids: this could in turn result in less side effects, higher patient and
      family satisfaction, and better outcomes.

      The use of ultrasound-guided greater occipital nerve block (GONB) for perioperative pain
      management of posterior fossa surgery in pediatrics is not previously reported.

      The authors hypothesize that ultrasound-guided greater occipital nerve block (GONB) for
      perioperative pain management of posterior fossa is feasible and superior to conventional
      methods for perioperative pain management.

      After institutional research ethics committee approval, 40 children aged (2-10 years), ASA
      physical status I or II, Glasgow Coma Scale (GCS) 15, scheduled for craniotomy for posterior
      fossa tumors will be recruited and a written informed consent will be obtained from the
      patient guardians.

      Anesthetic management:

      Patients will not receive any premedication. Upon arrival to the operating room heart rate,
      noninvasive blood pressure NBP and oxygen saturation SPO2 will be monitored using standard
      monitor (drȁger infinity vista XL) before inhalational induction of anesthesia using
      sevoflurane titration (2-8%). 20 or 22 G canula will be inserted after the patient is put to
      sleep. Anesthesia will be completed by fentanyl (2µg/kg) and atracurium 0.5mg/kg. if IV
      canula is present anesthesia will be induced by propofol (1-2 mg/kg), fentanyl (2µg/kg) and
      atracurium 0.5mg/kg After tracheal intubation anesthesia will be maintained using isoflurane
      1% in oxygen and air (FIO2 0.6), atracurium infusion at a rate of 0.5 mg/kg/h. Controlled
      ventilation will be adjusted to maintain moderate hyperventilation (end tidal CO2 30-35
      mmHg). A core temperature will be measured using nasopharyngeal probe and a Foley's catheter
      will be inserted in the urinary bladder. 22G radial arterial canula will be inserted for
      invasive blood pressure monitoring and blood sampling and central venous line (CVP) will be
      inserted under complete aseptic condition with ultrasound guidance and wide bore peripheral
      canula for fluid management.

      Greater occipital nerve block:

      After the patient is positioned in the prone position with mild neck flexion and after
      disinfection of the skin; the GON will be located in the short axis plane using the (M-Turbo
      TM) ultrasound system with a 6-13 MHz high-resolution linear ultrasound transducer (Sonosite,
      USA).

      The ultrasound probe will be placed in a transverse plane over the classical block site, at
      the level of the superior nuchal line, with the center of the probe at about 2-3 cm lateral
      to the external occipital protuberance. The GON will be identified in the short axis plane,
      Then, under real-time scanning, A 22 G canula will be advanced guided with ultrasound using
      an in-plane (IP) technique from lateral to medial to position the tip of the canula exactly
      at the center of the nerve. Thereafter, 2 ml of bupivacaine 0.5% will be injected to block
      the nerve. This technique will then be repeated on the other side.

      Vital signs (heart rate, arterial blood pressure, and SpO2) will be monitored continuously
      And recorded every 30 minutes intraoperatively, and at 2, 4, 6, 8, 12, 16, and 24 hours
      postoperatively. Bradycardia (heart rate less than 60 beats/minute) will be treated with
      atropine (0.02mg/kg IV). Fentanyl 0.5 µg /kg as rescue analgesia will be given if HR and
      systolic BP increased >20% of base line up to maximum 5 µg/ kg. 15 mg/kg of IV paracetamol
      will be given at the beginning of dural closure at the end of the procedure for both groups.

      Postoperative assessment and analgesic regimen:

      Objective Pain Scale (OPS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours
      postoperatively. The time to the first request of rescue postoperative analgesic will be:
      "the time interval between the onset of GONB and the first request to postoperative analgesia
      and or OPS score ˃2-3". When patients first complain of pain (OPS score ˃2-3) an intravenous
      paracetamol 15mg/kg will be given and will be repeated every 6 hours. Persistent or
      breakthrough pain will be managed with incremental intravenous morphine at a dose of
      0.05mg/kg to maintain resting OPS at < 2-3. Cumulative 24 hours analgesic consumption will be
      recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into two study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator performing the block and assessing study outcomes will all be blinded to the study group allocation. The intraoperative study outcomes will be assessed by an anesthetist who is not involved in the block performance and postoperative data will be collected by PICU trained nurses who are blinded to the study groups.
measure: Objective Pain Scale (OPS) at 12 hours postoperative.
time frame: at 12 hours postoperative
description: the score has five items(systolic blood pressure, crying, movement,agitation and complain of pain) with a minimum of zero and a maximum of 2 for each item.
total score = SUM of all points for all parameters
Minimum score: 0
Maximum score: 10
Maximum score if too young to complain of pain: 8 if the score is used with 5 items, a score exceeding the number 3 requires therapeutically effective analgesic. if the score is used with its 4 items, a score exceeding the number 2 requires therapeutic effective analgesic.
measure: Time to first request of postoperative rescue analgesics
time frame: within 24 hours
description: the time interval between the onset of GONB and the first request to postoperative analgesia and or OPS score ˃2- 3".
measure: Objective Pain Scale (OPS) up to 24 hours.
time frame: at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively
description: the score has five items(systolic blood pressure, crying, movement,agitation and complain of pain) with a minimum of zero and a maximum of 2 for each item.
total score = SUM of all points for all parameters
Minimum score: 0
Maximum score: 10
Maximum score if too young to complain of pain: 8 if the score is used with 5 items, a score exceeding the number 3 requires therapeutically effective analgesic. if the score is used with its 4 items, a score exceeding the number 2 requires therapeutic effective analgesic.
measure: Perioperative hemodynamic parameters
time frame: every 30 minutes intraoperative and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively
description: Heart rate
measure: side effects
time frame: within 24 hours
description: number of patients who develop scalp hematoma in the GONB group
measure: side effects
time frame: within 24 hours
description: number of patients who develop postoperative nausea and vomiting
measure: Perioperative hemodynamic parameters
time frame: every 30 minutes intraoperative and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively
description: systolic and diastolic arterial blood pressure.
arm group label: Greater occipital nerve block group (group GONB)
arm group type: Experimental
description: Patient in this group will receive 2 ml of bupivacaine 0.5% (up to a maximum of 2 mg/kg) subcutaneous under ultrasound guidance in the greater occipital nerve region bilaterally.
arm group label: Control group (group C):
arm group type: Placebo Comparator
description: Patient in this group will receive the intraoperative standard of care(intraoperative intravenous fentanyl and paracetamol)
intervention type: Drug
intervention name: ultrasound guided Greater occipital nerve block
description: ultrasound guided Greater occipital nerve block with 2 ml of bupivacaine 0.5% (up to a maximum of 2 mg/kg) subcutaneous under ultrasound guidance in the greater occipital nerve region bilaterally.
arm group label: Greater occipital nerve block group (group GONB)
intervention type: Drug
intervention name: control group C
description: Patient in this group will receive the intraoperative standard of care(intraoperative intravenous fentanyl and paracetamol)
arm group label: Control group (group C):
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Khaled Abdelfattah Abdallah Sarhan
investigator title: lecturer of anesthesia, SICU and pain management
mesh term: Infratentorial Neoplasms
sharing ipd: No