<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/NCT03777592</url>
  </required_header>
  <id_info>
    <org_study_id>2018-09-017-001</org_study_id>
    <nct_id>NCT03777592</nct_id>
  </id_info>
  <brief_title>Perioperative Erector Spinae Plane Block in Thoracoscopic Surgery</brief_title>
  <official_title>Correlation Between Perioperative Erector Spinae Plane Block and Postoperative Pain in Thoracoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kangbuk Samsung Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kangbuk Samsung 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The erector spinae plane block (ESPB) is a novel myofascial plane block. The ESPB is targeted&#xD;
      at anterior surface of the erector spinae plane, which is oriented cephalocaudally to the&#xD;
      spinal transverse process. Local anaesthetic injected in this plane can block the dorsal rami&#xD;
      and ventral rami and intercostal nerves. The aim of this study was to evaluate the effect of&#xD;
      ESPB on postoperative pain in thoracic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The erector spinae plane block (ESPB) is a newly defined regional anesthesia technique for&#xD;
      thoracic analgesia. The blocks were performed at the T5 level of the spine using an in-plane&#xD;
      approach.Previous studies were not designed as randomized controlled trial. In this study,&#xD;
      the efficacy of ESPB is to confirm with randomized controlled trial design. ESPB will be&#xD;
      performed in video assisted thoracoscopy preoperatively. After the surgery, the efficacy of&#xD;
      ESPB will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain scale</measure>
    <time_frame>the first 5 min after arriving at the recovery room</time_frame>
    <description>11-point numeric rating scale(&#xD;
(Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain scale</measure>
    <time_frame>20 min after arriving at the recovery room</time_frame>
    <description>11-point numeric rating scale (Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Regional Block</condition>
  <arm_group>
    <arm_group_label>ESPB with local agent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ESPB will be performed using 20ml of 0.5% ropivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESPB with saline</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>ESPB will be performed using 20ml of saline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>erector spinae plane block</intervention_name>
    <description>local anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces</description>
    <arm_group_label>ESPB with local agent</arm_group_label>
    <arm_group_label>ESPB with saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists Patients with physical class 1, 2&#xD;
&#xD;
          -  Patients undergoing video assisted thoracoscopic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who experienced side effects on local anesthetics&#xD;
&#xD;
          -  Patients with abnormal blood coagulation tests (INR&gt; 1.5)&#xD;
&#xD;
          -  Pregnant or lactating patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sung Hyun Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kangbuk Samsung Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sung Hyun Lee, MD</last_name>
    <phone>82-2-2001-2323</phone>
    <email>4321hoho@naver.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kyoung-Ho Ryu, MD</last_name>
    <phone>82-2-2001-1376</phone>
    <email>drkhryu@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>KangbukSamsung Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03181</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sung Hyun Lee, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kangbuk Samsung Hospital</investigator_affiliation>
    <investigator_full_name>Sung Hyun Lee</investigator_full_name>
    <investigator_title>Assistant Professor</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>
  <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/NCT03777592
org study id: 2018-09-017-001
nct id: NCT03777592
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The erector spinae plane block (ESPB) is a novel myofascial plane block. The ESPB is targeted
      at anterior surface of the erector spinae plane, which is oriented cephalocaudally to the
      spinal transverse process. Local anaesthetic injected in this plane can block the dorsal rami
      and ventral rami and intercostal nerves. The aim of this study was to evaluate the effect of
      ESPB on postoperative pain in thoracic surgery.
The erector spinae plane block (ESPB) is a newly defined regional anesthesia technique for
      thoracic analgesia. The blocks were performed at the T5 level of the spine using an in-plane
      approach.Previous studies were not designed as randomized controlled trial. In this study,
      the efficacy of ESPB is to confirm with randomized controlled trial design. ESPB will be
      performed in video assisted thoracoscopy preoperatively. After the surgery, the efficacy of
      ESPB will be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pain scale
time frame: the first 5 min after arriving at the recovery room
description: 11-point numeric rating scale(
(Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
measure: Pain scale
time frame: 20 min after arriving at the recovery room
description: 11-point numeric rating scale (Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
arm group label: ESPB with local agent
arm group type: Active Comparator
description: ESPB will be performed using 20ml of 0.5% ropivacaine.
arm group label: ESPB with saline
arm group type: Sham Comparator
description: ESPB will be performed using 20ml of saline.
intervention type: Procedure
intervention name: erector spinae plane block
description: local anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces
arm group label: ESPB with local agent
arm group label: ESPB with saline
criteria: 
gender: All
minimum age: 19 Years
maximum age: 85 Years
healthy volunteers: No
last name: Sung Hyun Lee, MD
role: Principal Investigator
affiliation: Kangbuk Samsung Hospital
last name: Sung Hyun Lee, MD
phone: 82-2-2001-2323
email: 4321hoho@naver.com
last name: Kyoung-Ho Ryu, MD
phone: 82-2-2001-1376
email: drkhryu@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kangbuk Samsung Hospital
investigator full name: Sung Hyun Lee
investigator title: Assistant Professor
mesh term: Pain, Postoperative
sharing ipd: No