<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/NCT04400721</url>
  </required_header>
  <id_info>
    <org_study_id>UZB-VUB-19-01</org_study_id>
    <secondary_id>2019-003534-17</secondary_id>
    <nct_id>NCT04400721</nct_id>
  </id_info>
  <brief_title>Efficacy of an Erector Spinae Plane Block in VATS/RATS</brief_title>
  <acronym>ESPAM</acronym>
  <official_title>The Effects of Thoracic Nerve Blocks on Postoperative Pain, Respiratory Function and Recovery in Patients Undergoing Thoracoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to study the analgesic and respiratory effects of the erector spinae plane&#xD;
      block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted&#xD;
      thoracic surgery (RATS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 120 subjects will be randomized into three groups (30 per group). Arm A: IV PCIA&#xD;
      Arm B: IV PCIA + ultrasound guided Erector spinae block (ESPB, Single shot of 30ml of 0.5%&#xD;
      solution of Naropin [Ropivacaine]) Arm C: IV PCIA + multilevel intra-thoracic intercostal&#xD;
      nerve block (ICB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) PCIA pumps&#xD;
      for all study cohorts will be programmed according to our institution's standard protocol&#xD;
      (Dipidolor [Piritramide] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). The erector spinae&#xD;
      block will be placed preoperatively, the intercostal block will be placed at the beginning of&#xD;
      the procedure. All patients will receive standard postoperative care. The patients will be&#xD;
      blinded for the study arm.&#xD;
&#xD;
      The primary endpoint of this study is postoperative pain and will be recorded by using the&#xD;
      numerical rating scale (NRS) pain score. Pain scores will be measured by the investigator at&#xD;
      rest and during coughing. Opioid consumption will be monitored and registered for.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 28, 2022</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>
    <intervention_model_description>Single-blinded, single-center, randomized, prospective study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of ESP block in decreasing postoperative pain intensity</measure>
    <time_frame>48 hours</time_frame>
    <description>Pain levels will be assessed using the 10 points Visual analogue Scale (VAS) where zero= no pain and 10= pain as bad as it can be. The vaS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Post-Op Complication</condition>
  <arm_group>
    <arm_group_label>PCIA arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard post-operative treatment with patient-controlled intravenous analgesia (Piritramide bolus = 2mg, bolus interval = 7 minutes, max 4 hour dose = 30mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESP block arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ultrasound guided Erector spinae block (Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine])</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IC block arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 ml of 0.5% solution of Naropin [Ropivacaine] per intercostal space, up to a maximum of 30ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erector spinae plane block with ropivacaine 3.75mg/ml</intervention_name>
    <description>Single shot erector spinae block</description>
    <arm_group_label>ESP block arm</arm_group_label>
    <arm_group_label>IC block arm</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients&#xD;
&#xD;
          -  age between 18 to 100 years old&#xD;
&#xD;
          -  ASA 1-3&#xD;
&#xD;
          -  scheduled for VATS&#xD;
&#xD;
          -  informed consent explained and signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt; 18 years old, &gt; 100 years old&#xD;
&#xD;
          -  ASA physical status &gt; 3&#xD;
&#xD;
          -  previous cardiac surgery or ipsilateral thoracic surgery&#xD;
&#xD;
          -  neuropsychiatric diseases&#xD;
&#xD;
          -  allergy to analgesics or local anesthetics or other medications used in the study&#xD;
&#xD;
          -  abuse of opioids or sedatives&#xD;
&#xD;
          -  contraindication to receive regional anesthesia (e.g. coagulation defect)&#xD;
&#xD;
          -  patients who could not understand the VAS pain-scoring system&#xD;
&#xD;
          -  patient refusal to follow participation&#xD;
&#xD;
          -  expected post operative mechanical ventilation&#xD;
&#xD;
          -  intolerance or allergy to any prescribed medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Domien Vanhonacker, MD</last_name>
    <phone>+32494652763</phone>
    <email>domienvanhonacker@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yanina Jansen, MD</last_name>
    <phone>+3247589116</phone>
    <email>yanina.jansen@uzbrussel.be</email>
  </overall_contact_backup>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</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/NCT04400721
org study id: UZB-VUB-19-01
secondary id: 2019-003534-17
nct id: NCT04400721
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study aims to study the analgesic and respiratory effects of the erector spinae plane
      block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted
      thoracic surgery (RATS).
A total of 120 subjects will be randomized into three groups (30 per group). Arm A: IV PCIA
      Arm B: IV PCIA + ultrasound guided Erector spinae block (ESPB, Single shot of 30ml of 0.5%
      solution of Naropin [Ropivacaine]) Arm C: IV PCIA + multilevel intra-thoracic intercostal
      nerve block (ICB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) PCIA pumps
      for all study cohorts will be programmed according to our institution's standard protocol
      (Dipidolor [Piritramide] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). The erector spinae
      block will be placed preoperatively, the intercostal block will be placed at the beginning of
      the procedure. All patients will receive standard postoperative care. The patients will be
      blinded for the study arm.

      The primary endpoint of this study is postoperative pain and will be recorded by using the
      numerical rating scale (NRS) pain score. Pain scores will be measured by the investigator at
      rest and during coughing. Opioid consumption will be monitored and registered for.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single-blinded, single-center, randomized, prospective study
primary purpose: Supportive Care
masking: Single (Participant)
measure: Efficacy of ESP block in decreasing postoperative pain intensity
time frame: 48 hours
description: Pain levels will be assessed using the 10 points Visual analogue Scale (VAS) where zero= no pain and 10= pain as bad as it can be. The vaS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels
arm group label: PCIA arm
arm group type: No Intervention
description: Standard post-operative treatment with patient-controlled intravenous analgesia (Piritramide bolus = 2mg, bolus interval = 7 minutes, max 4 hour dose = 30mg)
arm group label: ESP block arm
arm group type: Active Comparator
description: ultrasound guided Erector spinae block (Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine])
arm group label: IC block arm
arm group type: Active Comparator
description: 3 ml of 0.5% solution of Naropin [Ropivacaine] per intercostal space, up to a maximum of 30ml
intervention type: Drug
intervention name: Erector spinae plane block with ropivacaine 3.75mg/ml
description: Single shot erector spinae block
arm group label: ESP block arm
arm group label: IC block arm
other name: Naropin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Domien Vanhonacker, MD
phone: +32494652763
email: domienvanhonacker@gmail.com
last name: Yanina Jansen, MD
phone: +3247589116
email: yanina.jansen@uzbrussel.be
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Postoperative Complications
mesh term: Ropivacaine
sharing ipd: No