<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/NCT03808129</url>
  </required_header>
  <id_info>
    <org_study_id>P0001</org_study_id>
    <nct_id>NCT03808129</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane Block for Peroperative Analgesia and Intraabdominal Tissue Oxygenation</brief_title>
  <acronym>ESPB</acronym>
  <official_title>The Evaluation of Ultrasonography-guided Erector Spinae Plane Block in Perioperative Analgesia and Intraabdominal Tissue Oxygenation in Pediatric Patients Undergoing Lower Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif 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>
      Brief summary: Regional anesthesia decreases the need for intravenous analgesia in the&#xD;
      peri-operative period. Erector spinae plane (ESP) is a regional anesthesia technique shown to&#xD;
      be effective at the dorsal and ventral rami of the thoracic spinal nerve along with&#xD;
      sympathetic nerve fibers. The purpose is to demonstrate the contribution of ESP block to the&#xD;
      postoperative analgesia by ultrasonography and to increase intraabdominal tissue oxygenation&#xD;
      compared to the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 patients with American Society of Anesthesiologists (ASA) physical score I-II were&#xD;
      randomly divided into 25 patients in the ESP group and 25 patients in the control group.&#xD;
      Patients were premedicated with oral midazolam 0.5 mg kg-1, 30 minutes before surgery&#xD;
      Anesthesia monitorization was made with electrocardiogram, non-invasive blood pressure,&#xD;
      peripheral oxygen saturation (SpO2), end-tidal carbon dioxide, temperature, Bispectral index&#xD;
      (BIS), and Regional tissue saturation (rSO2). Anesthesia was induced with a face mask&#xD;
      distributing 8% sevoflurane and 50% air in oxygen while the patients were breathing&#xD;
      spontaneously. After anesthesia induction, peripheral venous access was established and&#xD;
      propofol 2 mg kg-1 and fentanyl citrate 1 μg kg-1 were administered. Laryngeal mask airways&#xD;
      were used to secure the upper airways. Anesthesia was maintained with sevoflurane and 50% air&#xD;
      in oxygen. The concentration of sevoflurane was adjusted by targeting BIS scores at 50-60 in&#xD;
      all groups. During the operations, fentanyl was administered at a dose of 0.5 μg kg-1 if the&#xD;
      blood pressure and heart rates were 20% higher than the baseline value. In ESP blok groups,&#xD;
      after general anesthesia induced, patients were placed in the lateral position and ESP block&#xD;
      was performed under ultrasound guidance. For ESP block, 1: 1 ratio of 0.25% bupivacaine and&#xD;
      0.4 ml / kg of 1% lidocaine was administered. In all groups, regional tissue saturation&#xD;
      (RSO2) was evaluated Continuously with near infrared spectroscopy (NIRS) probe from&#xD;
      anesthesia induction to the end of surgery. Commercially available device (INVOS Cerebral&#xD;
      Oximeter; somatics Corp, Troy, Mich) was used to monitor rSO2 values in the surgery side&#xD;
      flank during surgical intervention. Pain was evaluated and recorded using the FLACC (Face,&#xD;
      Legs, Activity, Cry, Consolability) scale at the 1st, 2nd, 8th, 12th and 24th hours. Total&#xD;
      analgesic consumption was recorded during the operation and postoperative time to first&#xD;
      analgesic drug and number of patients who required analgesic in the first 24 hours, parents&#xD;
      satisfaction score, discharge time as well as adverse effects such as nausea and vomiting&#xD;
      were recorded in the postoperative periods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Actual">April 20, 2019</completion_date>
  <primary_completion_date type="Actual">April 12, 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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>As the patients were under 18 years of age, the details of the procedure were explained to their parents and their consent was obtained. However, the patients were not included in the group. And also outcomes assessor staff were not aware of medication assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>FLACC scale</measure>
    <time_frame>From recovery of anesthesia to end of study ( postoperative 24 hours)</time_frame>
    <description>FLACC scale was used. The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale was a measurement used to assess pain for children between the ages of 6 months and 2 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIRS</measure>
    <time_frame>Before anesthesia induction to end of operation ( intraoperative 2 hours )</time_frame>
    <description>INVOS ;Somatic Corp, Troy, Mic sensors placed in surgical side of patients was used to detect peripheral perfusion and oxygen delivery (rSo2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first analgesic drug</measure>
    <time_frame>first 24 hour</time_frame>
    <description>Time to first analgesic drug will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for analgesic</measure>
    <time_frame>first 24 hour</time_frame>
    <description>Number of patients who required analgesic in the first 24 hour</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Lower Abdominal Surgery</condition>
  <arm_group>
    <arm_group_label>ESP Group: Bupivacaine and lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ESP Group: Bupivacaine and lidocaine: Erector Spinae Plane Block : (1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine) was administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group:</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine and Lidocaine</intervention_name>
    <description>ESP block was administered under general anesthesia before the surgery. Patients with ESP block, 1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine</description>
    <arm_group_label>ESP Group: Bupivacaine and lidocaine</arm_group_label>
    <other_name>ESP block</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children aged 6 months to 2 years&#xD;
&#xD;
          2. According to American Anesthesia Society Anesthesia Risk Scale ASA I-II class patients&#xD;
&#xD;
          3. Patients with lower abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children under 6 months and older than 2 years&#xD;
&#xD;
          2. According to American Anesthesia Society Anesthesia Risk Scale Patients with ASA&#xD;
             III-IV class&#xD;
&#xD;
          3. Patients with contraindication to regional anesthesia&#xD;
&#xD;
          4. Patients with a history of local anesthetic allergy&#xD;
&#xD;
          5. Patients with abnormal coagulation profile&#xD;
&#xD;
          6. Patients with infection at the injection site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PARVIN PINAR</last_name>
    <role>Study Chair</role>
    <affiliation>BEZMİALEM VAKIF UNIVERSITY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parvin Pinar</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>erector spinae plane block</keyword>
  <keyword>postoperative analgesia</keyword>
  <keyword>RSO2</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03808129
org study id: P0001
nct id: NCT03808129
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Brief summary: Regional anesthesia decreases the need for intravenous analgesia in the
      peri-operative period. Erector spinae plane (ESP) is a regional anesthesia technique shown to
      be effective at the dorsal and ventral rami of the thoracic spinal nerve along with
      sympathetic nerve fibers. The purpose is to demonstrate the contribution of ESP block to the
      postoperative analgesia by ultrasonography and to increase intraabdominal tissue oxygenation
      compared to the control group.
50 patients with American Society of Anesthesiologists (ASA) physical score I-II were
      randomly divided into 25 patients in the ESP group and 25 patients in the control group.
      Patients were premedicated with oral midazolam 0.5 mg kg-1, 30 minutes before surgery
      Anesthesia monitorization was made with electrocardiogram, non-invasive blood pressure,
      peripheral oxygen saturation (SpO2), end-tidal carbon dioxide, temperature, Bispectral index
      (BIS), and Regional tissue saturation (rSO2). Anesthesia was induced with a face mask
      distributing 8% sevoflurane and 50% air in oxygen while the patients were breathing
      spontaneously. After anesthesia induction, peripheral venous access was established and
      propofol 2 mg kg-1 and fentanyl citrate 1 μg kg-1 were administered. Laryngeal mask airways
      were used to secure the upper airways. Anesthesia was maintained with sevoflurane and 50% air
      in oxygen. The concentration of sevoflurane was adjusted by targeting BIS scores at 50-60 in
      all groups. During the operations, fentanyl was administered at a dose of 0.5 μg kg-1 if the
      blood pressure and heart rates were 20% higher than the baseline value. In ESP blok groups,
      after general anesthesia induced, patients were placed in the lateral position and ESP block
      was performed under ultrasound guidance. For ESP block, 1: 1 ratio of 0.25% bupivacaine and
      0.4 ml / kg of 1% lidocaine was administered. In all groups, regional tissue saturation
      (RSO2) was evaluated Continuously with near infrared spectroscopy (NIRS) probe from
      anesthesia induction to the end of surgery. Commercially available device (INVOS Cerebral
      Oximeter; somatics Corp, Troy, Mich) was used to monitor rSO2 values in the surgery side
      flank during surgical intervention. Pain was evaluated and recorded using the FLACC (Face,
      Legs, Activity, Cry, Consolability) scale at the 1st, 2nd, 8th, 12th and 24th hours. Total
      analgesic consumption was recorded during the operation and postoperative time to first
      analgesic drug and number of patients who required analgesic in the first 24 hours, parents
      satisfaction score, discharge time as well as adverse effects such as nausea and vomiting
      were recorded in the postoperative periods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: As the patients were under 18 years of age, the details of the procedure were explained to their parents and their consent was obtained. However, the patients were not included in the group. And also outcomes assessor staff were not aware of medication assignment.
measure: FLACC scale
time frame: From recovery of anesthesia to end of study ( postoperative 24 hours)
description: FLACC scale was used. The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale was a measurement used to assess pain for children between the ages of 6 months and 2 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
measure: NIRS
time frame: Before anesthesia induction to end of operation ( intraoperative 2 hours )
description: INVOS ;Somatic Corp, Troy, Mic sensors placed in surgical side of patients was used to detect peripheral perfusion and oxygen delivery (rSo2)
measure: Time to first analgesic drug
time frame: first 24 hour
description: Time to first analgesic drug will be recorded
measure: Need for analgesic
time frame: first 24 hour
description: Number of patients who required analgesic in the first 24 hour
arm group label: ESP Group: Bupivacaine and lidocaine
arm group type: Active Comparator
description: ESP Group: Bupivacaine and lidocaine: Erector Spinae Plane Block : (1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine) was administered.
arm group label: control group
arm group type: No Intervention
description: Control Group:
intervention type: Drug
intervention name: Bupivacaine and Lidocaine
description: ESP block was administered under general anesthesia before the surgery. Patients with ESP block, 1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine
arm group label: ESP Group: Bupivacaine and lidocaine
other name: ESP block
criteria: 
gender: All
minimum age: 6 Months
maximum age: 2 Years
healthy volunteers: Accepts Healthy Volunteers
last name: PARVIN PINAR
role: Study Chair
affiliation: BEZMİALEM VAKIF UNIVERSITY
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Lidocaine
mesh term: Bupivacaine