<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/NCT02988700</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00008718/36800</org_study_id>
    <nct_id>NCT02988700</nct_id>
  </id_info>
  <brief_title>Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery</brief_title>
  <acronym>ITVSEpidural</acronym>
  <official_title>Safety and Analgesic Efficacy of Spinal Versus Caudal Block in Pediatric Infra-umbilical Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Caudal analgesia along with general anesthesia is a very popular regional technique for&#xD;
      prolonged postoperative analgesia in different pediatric surgical procedures where the&#xD;
      surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for&#xD;
      approximately 4-6 hours.&#xD;
&#xD;
      Recently, the use of spinal anesthesia in infants and children requiring surgeries of&#xD;
      sub-umbilical region is gaining considerable popularity worldwide.&#xD;
&#xD;
      - The ease of performance and the safety regarding cardio-respiratory functions makes spinal&#xD;
      anesthesia as an alternative to general anesthesia in infants and children undergoing&#xD;
      surgeries of sub-umbilical regions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The historic view that young children neither respond to, nor remember, painful experiences&#xD;
      to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical&#xD;
      patients experienced moderate or severe postoperative pain and 75% had insufficient&#xD;
      analgesia.&#xD;
&#xD;
      -Pediatric acute pain services use techniques of concurrent or co-analgesia based on four&#xD;
      classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory&#xD;
      drugs (NSAIDs), and acetaminophen (paracetamol).&#xD;
&#xD;
      Caudal analgesia along with general anesthesia is a very popular regional technique for&#xD;
      prolonged postoperative analgesia in different pediatric surgical procedures where the&#xD;
      surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for&#xD;
      approximately 4-6 hours.&#xD;
&#xD;
      Recently, the use of spinal anesthesia in infants and children requiring surgeries of&#xD;
      sub-umbilical region is gaining considerable popularity worldwide.&#xD;
&#xD;
      - The ease of performance and the safety regarding cardio-respiratory functions makes spinal&#xD;
      anesthesia as an alternative to general anesthesia in infants and children undergoing&#xD;
      surgeries of sub-umbilical regions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <phase>Phase 2/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>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FLACC Score</measure>
    <time_frame>24 hours</time_frame>
    <description>FLACC scores will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total consumption of rescue analgesics</measure>
    <time_frame>24 hours</time_frame>
    <description>The total consumption of postoperative rescue analgesics will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Agitation</measure>
    <time_frame>60 min.</time_frame>
    <description>Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>24 hours</time_frame>
    <description>Any adverse effect will be treated and recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual motor paralysis</measure>
    <time_frame>6 hours</time_frame>
    <description>By the Modified Bromage scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Spinal group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intrathecal hyperbaric bupivacaine 0.25mg/kg will be give by lumber puncture that will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.&#xD;
be given by .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caudal group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>caudal plain bupivacaine 2.5mg/kg 0.25% will be given caudally in The sacral hiatus between the sacral conru that will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance &quot;give&quot; or &quot;pop&quot; will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%</intervention_name>
    <description>The lumber puncture will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.</description>
    <arm_group_label>Spinal group</arm_group_label>
    <other_name>Marcain</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>caudal plain bupivacaine 2.5mg/kg 0.25%</intervention_name>
    <description>The sacral hiatus between the sacral conru will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance &quot;give&quot; or &quot;pop&quot; will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.</description>
    <arm_group_label>Caudal group</arm_group_label>
    <other_name>Bucain</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 2-12 years.&#xD;
&#xD;
          -  Weight: 15-40 kg.&#xD;
&#xD;
          -  Sex: both males and females.&#xD;
&#xD;
          -  ASA physical status: 1-II.&#xD;
&#xD;
          -  Operation: surgery below umbilicus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic reaction to local anesthetics (LAs).&#xD;
&#xD;
          -  Local or systemic infection (risk of meningitis).&#xD;
&#xD;
          -  Coagulopathy.&#xD;
&#xD;
          -  Intracranial hypertension.&#xD;
&#xD;
          -  Hydrocephalus.&#xD;
&#xD;
          -  Intracranial hemorrhage.&#xD;
&#xD;
          -  Parental refusal.&#xD;
&#xD;
          -  Hypovolemia.&#xD;
&#xD;
          -  Spinal deformities, such as spina bifida or myelomeningocele.&#xD;
&#xD;
          -  Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural&#xD;
             leak.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hala S Abdel-Ghaffar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hala Saad Abdel-Ghaffar</name>
      <address>
        <city>Assiut</city>
        <state>Assiut Governorate</state>
        <zip>715715</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Hala Saad Abdel-Ghaffar</investigator_full_name>
    <investigator_title>Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.</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>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>


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/NCT02988700
org study id: IRB00008718/36800
nct id: NCT02988700
lead sponsor: 
has dmc: Yes
Caudal analgesia along with general anesthesia is a very popular regional technique for
      prolonged postoperative analgesia in different pediatric surgical procedures where the
      surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for
      approximately 4-6 hours.

      Recently, the use of spinal anesthesia in infants and children requiring surgeries of
      sub-umbilical region is gaining considerable popularity worldwide.

      - The ease of performance and the safety regarding cardio-respiratory functions makes spinal
      anesthesia as an alternative to general anesthesia in infants and children undergoing
      surgeries of sub-umbilical regions.
The historic view that young children neither respond to, nor remember, painful experiences
      to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical
      patients experienced moderate or severe postoperative pain and 75% had insufficient
      analgesia.

      -Pediatric acute pain services use techniques of concurrent or co-analgesia based on four
      classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory
      drugs (NSAIDs), and acetaminophen (paracetamol).

      Caudal analgesia along with general anesthesia is a very popular regional technique for
      prolonged postoperative analgesia in different pediatric surgical procedures where the
      surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for
      approximately 4-6 hours.

      Recently, the use of spinal anesthesia in infants and children requiring surgeries of
      sub-umbilical region is gaining considerable popularity worldwide.

      - The ease of performance and the safety regarding cardio-respiratory functions makes spinal
      anesthesia as an alternative to general anesthesia in infants and children undergoing
      surgeries of sub-umbilical regions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: FLACC Score
time frame: 24 hours
description: FLACC scores will be recorded.
measure: Total consumption of rescue analgesics
time frame: 24 hours
description: The total consumption of postoperative rescue analgesics will be recorded.
measure: Postoperative Agitation
time frame: 60 min.
description: Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.
measure: Adverse effects
time frame: 24 hours
description: Any adverse effect will be treated and recorded.
measure: Residual motor paralysis
time frame: 6 hours
description: By the Modified Bromage scale
arm group label: Spinal group
arm group type: Active Comparator
description: Intrathecal hyperbaric bupivacaine 0.25mg/kg will be give by lumber puncture that will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.
be given by .
arm group label: Caudal group
arm group type: Active Comparator
description: caudal plain bupivacaine 2.5mg/kg 0.25% will be given caudally in The sacral hiatus between the sacral conru that will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.
intervention type: Drug
intervention name: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%
description: The lumber puncture will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.
arm group label: Spinal group
other name: Marcain
intervention type: Drug
intervention name: caudal plain bupivacaine 2.5mg/kg 0.25%
description: The sacral hiatus between the sacral conru will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.
arm group label: Caudal group
other name: Bucain
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Hala S Abdel-Ghaffar, MD
role: Principal Investigator
affiliation: Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hala Saad Abdel-Ghaffar
investigator title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No