<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/NCT04457115</url>
  </required_header>
  <id_info>
    <org_study_id>ELETTRA</org_study_id>
    <secondary_id>2613</secondary_id>
    <nct_id>NCT04457115</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Pain Control in Modified Radical Mastectomy</brief_title>
  <official_title>Comparison of Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Intra and Postoperative Pain Control in Modified Radical Mastectomy: a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AUSL Romagna Rimini</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AUSL Romagna Rimini</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>
      The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block&#xD;
      versus thoracic paravertebral (TPV) block in the post-operative pain control after radical&#xD;
      mastectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary outcome of our study is to compare the effectiveness of two regional anesthesia&#xD;
      techniques, ESP block and TPV block, in the post-operative pain-control after radical&#xD;
      mastectomy.&#xD;
&#xD;
      We will also evaluate both intra and post-operative opioid consumption, the incidence of&#xD;
      PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and&#xD;
      the incidence of chronic pain 6 months after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 27, 2020</start_date>
  <completion_date type="Actual">November 15, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative pain assessment</measure>
    <time_frame>12 hours</time_frame>
    <description>post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>3 days</time_frame>
    <description>The number of days of hospitalization after surgery will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the incidence and severity of persistent pain 6 months after surgery</measure>
    <time_frame>six months</time_frame>
    <description>Evaluate the incidence and severity of persistent pain 6 months after surgery using Numeric rating scale (from 0, no pain, to 10, worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid use</measure>
    <time_frame>36 hours</time_frame>
    <description>Intra and post-operative opioid use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of PONV</measure>
    <time_frame>36 hours</time_frame>
    <description>Incidence of post operative nausea and vomiting (PONV) in the first 36 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patient satisfaction with the anesthesiological technique</measure>
    <time_frame>36 hours</time_frame>
    <description>Patients is requested to fill out a pre-printed sheet on their judgment of the anesthesiological procedure, in which they can express a value from 0 to 5, where 0 indicates &quot;entirely dissatisfied&quot; and 5 indi- cates &quot;very satisfied&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Breast Surgery</condition>
  <condition>Thoracic Paravertebral Block</condition>
  <condition>Post-operative Pain Control</condition>
  <condition>Erector Spinae Plane Block</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>TPV Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thoracic paravertebral block performed at thoracic level T2-T3 and T4-T5 with administration of Ropivacaine 0.7% 8 ml for each level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESP Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Erector spinae plane block performed at thoracic level T2 and T5 with administration of Ropivacaine 0.5% 12 ml for each level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thoracic paravertebral block</intervention_name>
    <description>Thoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level</description>
    <arm_group_label>TPV Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector spinae plane Block</intervention_name>
    <description>Erector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level</description>
    <arm_group_label>ESP Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged between 18 and 85&#xD;
&#xD;
          -  American Society of Anesthesiologists classification I - III&#xD;
&#xD;
          -  Signature of consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathies and / or use of antiplatelet / anticoagulant drugs&#xD;
&#xD;
          -  Infections and/or lesions at the puncture site,&#xD;
&#xD;
          -  BMI ≥40&#xD;
&#xD;
          -  allergies and / or contraindications to the administration of the drugs used in the&#xD;
             study,&#xD;
&#xD;
          -  use of chronic opioid therapy&#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>Domenico P Santonastaso, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AUSL Romagna, M. Bufalini Hospital, Cesena</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Domenico Pietro Santonastaso</name>
      <address>
        <city>Cesena</city>
        <state>Emilia Romagna</state>
        <zip>47521</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast surgery</keyword>
  <keyword>Thoracic paravertebral block</keyword>
  <keyword>Erector spinae plane block</keyword>
  <keyword>Mastectomy</keyword>
  <keyword>post-operative pain control</keyword>
  <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>
  <pending_results>
    <submitted>October 21, 2022</submitted>
    <returned>September 1, 2023</returned>
  </pending_results>
  <!-- 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/NCT04457115
org study id: ELETTRA
secondary id: 2613
nct id: NCT04457115
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block
      versus thoracic paravertebral (TPV) block in the post-operative pain control after radical
      mastectomy.
Primary outcome of our study is to compare the effectiveness of two regional anesthesia
      techniques, ESP block and TPV block, in the post-operative pain-control after radical
      mastectomy.

      We will also evaluate both intra and post-operative opioid consumption, the incidence of
      PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and
      the incidence of chronic pain 6 months after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post-operative pain assessment
time frame: 12 hours
description: post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)
measure: Length of hospital stay
time frame: 3 days
description: The number of days of hospitalization after surgery will be assessed
measure: Evaluate the incidence and severity of persistent pain 6 months after surgery
time frame: six months
description: Evaluate the incidence and severity of persistent pain 6 months after surgery using Numeric rating scale (from 0, no pain, to 10, worst pain)
measure: Opioid use
time frame: 36 hours
description: Intra and post-operative opioid use
measure: Incidence of PONV
time frame: 36 hours
description: Incidence of post operative nausea and vomiting (PONV) in the first 36 hours
measure: Assessment of patient satisfaction with the anesthesiological technique
time frame: 36 hours
description: Patients is requested to fill out a pre-printed sheet on their judgment of the anesthesiological procedure, in which they can express a value from 0 to 5, where 0 indicates "entirely dissatisfied" and 5 indi- cates "very satisfied"
arm group label: TPV Block
arm group type: Experimental
description: Thoracic paravertebral block performed at thoracic level T2-T3 and T4-T5 with administration of Ropivacaine 0.7% 8 ml for each level.
arm group label: ESP Block
arm group type: Experimental
description: Erector spinae plane block performed at thoracic level T2 and T5 with administration of Ropivacaine 0.5% 12 ml for each level.
intervention type: Procedure
intervention name: Thoracic paravertebral block
description: Thoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level
arm group label: TPV Block
intervention type: Procedure
intervention name: Erector spinae plane Block
description: Erector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level
arm group label: ESP Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Domenico P Santonastaso, MD
role: Principal Investigator
affiliation: AUSL Romagna, M. Bufalini Hospital, Cesena
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No
submitted: October 21, 2022
returned: September 1, 2023