<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/NCT03790566</url>
  </required_header>
  <id_info>
    <org_study_id>72109855-604.01.01-53213</org_study_id>
    <nct_id>NCT03790566</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases</brief_title>
  <acronym>ESPPOP</acronym>
  <official_title>Comparison of Erector Spinae Plane Block With Transversus Abdominus Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aybike Onur Gonen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ayse Cigdem Tutuncu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaya, Guner, M.D.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rahsan Ozcan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Regional anesthesia decreases the need for intravenous analgesia in the peri-operative&#xD;
      period. Erector spinae plane (ESP) and transversus abdominus plane (TAP) blocks are two&#xD;
      common regional anesthesia techniques shown to be effective in open abdominal surgeries. We&#xD;
      aim to compare effectiveness of ESP block with TAP block for peri-operative analgesia in&#xD;
      pediatric open pyeloplasty patients with a flank incision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regional anesthesia for effective post-operative pain management is a part of the pediatric&#xD;
      Enhanced Recovery After Surgery (ERAS) protocol. Epidural anesthesia is the gold standard for&#xD;
      analgesia for open abdominal surgeries, however difficulties in application and possible&#xD;
      complications deter clinicians from utilizing this method. Safe and effective alternatives to&#xD;
      epidural anesthesia has been a critical and popular focus of clinical research in recent&#xD;
      years. Transversus abdominus plane (TAP) block is an alternative technique shown to be&#xD;
      effective in pediatric open abdominal surgeries.&#xD;
&#xD;
      Erector spinae plane (ESP) block was described as an effective block for multi-dermatome pain&#xD;
      after thoracic surgery. It is emerging as a safe and easy-to-perform alternative to epidural&#xD;
      anesthesia for pelvic, abdominal and thoracic surgery.&#xD;
&#xD;
      During an open pyeloplasty, the flank incision goes through the transversus abdominus plane,&#xD;
      where the local anesthetic is injected for TAP block. This may weaken the analgesic effect of&#xD;
      the block. In the ESP block, local anesthetic diffuses cranio-caudally through the fascia of&#xD;
      erector spinae muscles and the flank incision does not disturb this plane. We aim to compare&#xD;
      the effectiveness of ESP block with TAP block in open pyeloplasty patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Anticipated">September 25, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2, 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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Remifentanil need</measure>
    <time_frame>During the operation</time_frame>
    <description>Intraoperative remifentanil requirement as rescue analgesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative analgesia need</measure>
    <time_frame>24 hours post-operatively</time_frame>
    <description>Pain score is assessed with FLACC (Face, Legs, Activity, Cry, Consolability) scale. A score of 2, 3, 4 or 5 warrants for intravenous paracetamol need and a score of 6 and above warrants for intravenous tramadol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parental satisfaction with analgesia</measure>
    <time_frame>24 hours post-operatively</time_frame>
    <description>Parents will be asked how satisfied they are with the patient's pain control: 1. Dissatisfied, 2. Partially satisfied 3. Satisfied</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Anesthesia and Analgesia</condition>
  <condition>Pediatrics</condition>
  <condition>Urologic Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>Erector spinae plane block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With the patient in lateral decubitus position (surgical side up), the transverse processes of T10-T12 vertebrae and erector spinae (ES) fascia are visualized 1-2 cm lateral to the vertebral spine using a linear ultrasound probe. A 22G peripheral block needle is introduced with in-plane technique under the ES muscle and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected in this plane after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transversus abdominus plane block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>With the patient in supine position, three layers of abdominal muscle are visualized using the linear ultrasound probe held with the long axis on the mid-axillary line above the iliac crest. 22G peripheral block needle is introduced in-plane into the fascia between the internal oblique and transversus abdominus muscles and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected in this plane after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>0.5 ml/kg 0.25% bupivacaine</description>
    <arm_group_label>Erector spinae plane block</arm_group_label>
    <arm_group_label>Transversus abdominus plane block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologist class I, II or III&#xD;
&#xD;
          -  Patients scheduled for elective open pyeloplasty surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Local anesthetic allergy or other contraindication to local anesthetic use&#xD;
&#xD;
          -  Coagulation disorders&#xD;
&#xD;
          -  History of chronic pain&#xD;
&#xD;
          -  Patient/Family refusal&#xD;
&#xD;
          -  History of scoliosis, spinae bifida, abdominal wall defect&#xD;
&#xD;
          -  Past surgical procedures with abdominal wall incision&#xD;
&#xD;
          -  Plan to extend the flank incision for additional surgical intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pinar Kendigelen, Assoc. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University Cerrahpasa Medical Faculty</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pinar Kendigelen, Assoc. Prof.</last_name>
    <phone>+905325868734</phone>
    <email>pinarken@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aybike Onur Gonen, MD</last_name>
    <phone>+905322701086</phone>
    <email>aybikeonur@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Istanbul University Cerrahpasa Medical Faculty</name>
      <address>
        <city>Istanbul</city>
        <state>Please Select</state>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pinar Kendigelen, Assoc.Prof.</last_name>
      <phone>+905325868734</phone>
      <email>pinarken@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Aybike Onur Gonen, MD</last_name>
      <phone>+905322701086</phone>
      <email>aybikeonur@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Pınar Kendigelen, Assoc.Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ayse C Tutuncu, Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guner Kaya, Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aybike Onur Gonen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rahsan Ozcan, Assoc.Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>pinar kendigelen</investigator_full_name>
    <investigator_title>Assoc. Prof.</investigator_title>
  </responsible_party>
  <keyword>ESP block</keyword>
  <keyword>TAP block</keyword>
  <keyword>pyeloplasty</keyword>
  <keyword>erector spina plane block</keyword>
  <keyword>transversus abdominus plane block</keyword>
  <keyword>flank incision</keyword>
  <keyword>post-op analgesia</keyword>
  <keyword>peri-op analgesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03790566
org study id: 72109855-604.01.01-53213
nct id: NCT03790566
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Regional anesthesia decreases the need for intravenous analgesia in the peri-operative
      period. Erector spinae plane (ESP) and transversus abdominus plane (TAP) blocks are two
      common regional anesthesia techniques shown to be effective in open abdominal surgeries. We
      aim to compare effectiveness of ESP block with TAP block for peri-operative analgesia in
      pediatric open pyeloplasty patients with a flank incision.
Regional anesthesia for effective post-operative pain management is a part of the pediatric
      Enhanced Recovery After Surgery (ERAS) protocol. Epidural anesthesia is the gold standard for
      analgesia for open abdominal surgeries, however difficulties in application and possible
      complications deter clinicians from utilizing this method. Safe and effective alternatives to
      epidural anesthesia has been a critical and popular focus of clinical research in recent
      years. Transversus abdominus plane (TAP) block is an alternative technique shown to be
      effective in pediatric open abdominal surgeries.

      Erector spinae plane (ESP) block was described as an effective block for multi-dermatome pain
      after thoracic surgery. It is emerging as a safe and easy-to-perform alternative to epidural
      anesthesia for pelvic, abdominal and thoracic surgery.

      During an open pyeloplasty, the flank incision goes through the transversus abdominus plane,
      where the local anesthetic is injected for TAP block. This may weaken the analgesic effect of
      the block. In the ESP block, local anesthetic diffuses cranio-caudally through the fascia of
      erector spinae muscles and the flank incision does not disturb this plane. We aim to compare
      the effectiveness of ESP block with TAP block in open pyeloplasty patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Remifentanil need
time frame: During the operation
description: Intraoperative remifentanil requirement as rescue analgesia
measure: Post-operative analgesia need
time frame: 24 hours post-operatively
description: Pain score is assessed with FLACC (Face, Legs, Activity, Cry, Consolability) scale. A score of 2, 3, 4 or 5 warrants for intravenous paracetamol need and a score of 6 and above warrants for intravenous tramadol
measure: Parental satisfaction with analgesia
time frame: 24 hours post-operatively
description: Parents will be asked how satisfied they are with the patient's pain control: 1. Dissatisfied, 2. Partially satisfied 3. Satisfied
arm group label: Erector spinae plane block
arm group type: Experimental
description: With the patient in lateral decubitus position (surgical side up), the transverse processes of T10-T12 vertebrae and erector spinae (ES) fascia are visualized 1-2 cm lateral to the vertebral spine using a linear ultrasound probe. A 22G peripheral block needle is introduced with in-plane technique under the ES muscle and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected in this plane after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP.
arm group label: Transversus abdominus plane block
arm group type: Active Comparator
description: With the patient in supine position, three layers of abdominal muscle are visualized using the linear ultrasound probe held with the long axis on the mid-axillary line above the iliac crest. 22G peripheral block needle is introduced in-plane into the fascia between the internal oblique and transversus abdominus muscles and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected in this plane after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP.
intervention type: Drug
intervention name: Bupivacaine
description: 0.5 ml/kg 0.25% bupivacaine
arm group label: Erector spinae plane block
arm group label: Transversus abdominus plane block
criteria: 
gender: All
minimum age: 1 Year
maximum age: 10 Years
healthy volunteers: No
last name: Pinar Kendigelen, Assoc. Prof.
role: Principal Investigator
affiliation: Istanbul University Cerrahpasa Medical Faculty
last name: Pinar Kendigelen, Assoc. Prof.
phone: +905325868734
email: pinarken@gmail.com
last name: Aybike Onur Gonen, MD
phone: +905322701086
email: aybikeonur@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: pinar kendigelen
investigator title: Assoc. Prof.
mesh term: Bupivacaine
sharing ipd: Undecided