<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/NCT03831581</url>
  </required_header>
  <id_info>
    <org_study_id>UdeA1003</org_study_id>
    <nct_id>NCT03831581</nct_id>
  </id_info>
  <brief_title>Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block</brief_title>
  <official_title>Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Antioquia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Antioquia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Interventional study that evaluate dermatomal distribution and its demographic determinants&#xD;
      in patients who underwent to Erector Spinae Plane (ESP) block&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interventional study that evaluate dermatomal distribution with pinprick and cold, and its&#xD;
      demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block with&#xD;
      20 ml of bupivacaine 0.5% at the thoracic level in patients with pain in the thorax and upper&#xD;
      abdomen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Assignment interventional</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dermatomes with sensitive block</measure>
    <time_frame>60 minutes</time_frame>
    <description>Number (average) of dermatomes with sensitive block with pinprick and cold achieved at 60 minutes after the Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5%. Also, observe the distribution pattern.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>weight</measure>
    <time_frame>60 minutes</time_frame>
    <description>weight in kilograms and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>60 minutes and 24 hours</time_frame>
    <description>Frequency of adverse events (hypotension, pneumothorax, neurological deficit, bradycardia) after the Erector Spinae Plane (ESP) block.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success rate</measure>
    <time_frame>60 minutes and 24 hours</time_frame>
    <description>Success rate (Blocking of at least 2 continuous dermatomes at the puncture site measured with pinprick and cold)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of satisfaction</measure>
    <time_frame>60 minutes and 24 hours</time_frame>
    <description>Degree of satisfaction evaluated with the Likert scale of 4 points (1 dissatisfied, 2 slightly dissatisfied, 3 slightly satisfied, 4 satisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>60 minutes and 24 hours</time_frame>
    <description>Change From Baseline in Pain Scores on the Visual analogue scale (VAS) from 1 to 10 at 60 minutes and 24 hours after the ESP block.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>60 minutes</time_frame>
    <description>Height in meters and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age</measure>
    <time_frame>60 minutes</time_frame>
    <description>Age in years and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Pain, Chronic</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Erector Spinae Plane Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with chest pain or upper abdomen underwent Erector Spinae Plane Block guided by ultrasound, bupivacaine 0.5% 20 ml was administered in the interfascial plane between the transverse process of T5 and the erector muscles of the spine, 60 minutes after dermatomes distribution was evaluated with pinprick and cold.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector Spinae Plane Block</intervention_name>
    <description>In patients with chest pain, ultrasound-guided Erector Spinae Plane Block block was performed at T5 transverse process in the cephalo-caudal direction with Tuohy 18 gauge needle in plane until the needle tip was located in the interfascial plane between the transverse process and the erector spinae muscles, 20 ml of bupivacaine 0.5% was administered and a catheter was inserted if indicated.</description>
    <arm_group_label>Erector Spinae Plane Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years, in the acute / chronic pain service that presents pain&#xD;
             in the thoracic region and / or upper hemiabdomen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women in pregnancy&#xD;
&#xD;
          -  Patients with less than 50 Kg of weight&#xD;
&#xD;
          -  Dissent of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adriana Cadavid</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad de Antioquia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>hospital universitario San Vicente Fundacion</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Erector Spinae Plane</keyword>
  <keyword>Erector Spinae Plane Block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only final results of research</ipd_description>
  </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/NCT03831581
org study id: UdeA1003
nct id: NCT03831581
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Interventional study that evaluate dermatomal distribution and its demographic determinants
      in patients who underwent to Erector Spinae Plane (ESP) block
Interventional study that evaluate dermatomal distribution with pinprick and cold, and its
      demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block with
      20 ml of bupivacaine 0.5% at the thoracic level in patients with pain in the thorax and upper
      abdomen.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Assignment interventional
primary purpose: Treatment
masking: None (Open Label)
measure: Dermatomes with sensitive block
time frame: 60 minutes
description: Number (average) of dermatomes with sensitive block with pinprick and cold achieved at 60 minutes after the Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5%. Also, observe the distribution pattern.
measure: weight
time frame: 60 minutes
description: weight in kilograms and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
measure: Adverse events
time frame: 60 minutes and 24 hours
description: Frequency of adverse events (hypotension, pneumothorax, neurological deficit, bradycardia) after the Erector Spinae Plane (ESP) block.
measure: Success rate
time frame: 60 minutes and 24 hours
description: Success rate (Blocking of at least 2 continuous dermatomes at the puncture site measured with pinprick and cold)
measure: Degree of satisfaction
time frame: 60 minutes and 24 hours
description: Degree of satisfaction evaluated with the Likert scale of 4 points (1 dissatisfied, 2 slightly dissatisfied, 3 slightly satisfied, 4 satisfied).
measure: Visual Analogue Scale (VAS)
time frame: 60 minutes and 24 hours
description: Change From Baseline in Pain Scores on the Visual analogue scale (VAS) from 1 to 10 at 60 minutes and 24 hours after the ESP block.
measure: Height
time frame: 60 minutes
description: Height in meters and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
measure: Age
time frame: 60 minutes
description: Age in years and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
arm group label: Erector Spinae Plane Block
arm group type: Experimental
description: Patients with chest pain or upper abdomen underwent Erector Spinae Plane Block guided by ultrasound, bupivacaine 0.5% 20 ml was administered in the interfascial plane between the transverse process of T5 and the erector muscles of the spine, 60 minutes after dermatomes distribution was evaluated with pinprick and cold.
intervention type: Procedure
intervention name: Erector Spinae Plane Block
description: In patients with chest pain, ultrasound-guided Erector Spinae Plane Block block was performed at T5 transverse process in the cephalo-caudal direction with Tuohy 18 gauge needle in plane until the needle tip was located in the interfascial plane between the transverse process and the erector spinae muscles, 20 ml of bupivacaine 0.5% was administered and a catheter was inserted if indicated.
arm group label: Erector Spinae Plane Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Adriana Cadavid
role: Study Chair
affiliation: Universidad de Antioquia
facility: 
country: Colombia
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Chronic Pain
sharing ipd: No
ipd description: Only final results of research