<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/NCT03016117</url>
  </required_header>
  <id_info>
    <org_study_id>SanSalvatoreH</org_study_id>
    <nct_id>NCT03016117</nct_id>
  </id_info>
  <brief_title>Anesthetic Efficacy of PECS II Block and Parasternal Block</brief_title>
  <official_title>Anesthetic Efficacy of PECS II Block and Parasternal Block for Quadrantectomy With or Without Axillary Dissection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Salvatore Hospital of L'Aquila</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Salvatore Hospital of L'Aquila</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 study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during&#xD;
      quadrantectomy with or without axillary dissection, in breast cancer surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients receive Pecs II block and parasternal block, under ultrasound guidance. Pecs II&#xD;
      block, performed at the 4th rib level, and parasternal block performed at the level of the&#xD;
      2nd and 4th intercostal space level. Data on the anesthesia, side effects and pain, will be&#xD;
      recorded&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">November 29, 2018</completion_date>
  <primary_completion_date type="Actual">October 25, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anesthetic efficacy</measure>
    <time_frame>The anesthetic efficacy was assessed in the first 72 hours, after block</time_frame>
    <description>The anesthetic efficacy is tested by cold and touch test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Painkillers request</measure>
    <time_frame>The painkillers request was assessed in the first 72 hours, after surgery</time_frame>
    <description>mg of morphine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>The side effects recorded in the first 72 hours, after surgery</time_frame>
    <description>Nausea, vomiting, local anesthetic systemic toxicity</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Pecs II block and parasternal block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pecs II block and parasternal block performed to provide anesthesia of breast, before of quadrantectomy with or without axillary dissection. Pecs II block performed at the 4th rib level and 20 ml of 0.5% Levobupivacaine injected, and parasternal block performed at the level of the 2nd and 4th intercostal space level, and 4 ml of 0.375% Levobupivacaine injected</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pecs II block and parasternal block</intervention_name>
    <description>The Pecs II block will be performed under ultrasound guidance, at fourth rib level, on the axillary line, into the fascial plane between pectoralis minor muscle and serratus muscle. The parasternal block will be performed under ultrasound guidance, at the second and fourth intercostal space, between the pectoralis major muscle and the intercostal muscles, near to the external intercostal membrane.</description>
    <arm_group_label>Pecs II block and parasternal block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who need of quadrantectomy with or without axillary dissection&#xD;
&#xD;
          -  ASA I-III patients&#xD;
&#xD;
          -  age between 18 and 75 years&#xD;
&#xD;
          -  filled informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  obesity (BMI &gt; 39,99)&#xD;
&#xD;
          -  radical mastectomy&#xD;
&#xD;
          -  ASA IV patients&#xD;
&#xD;
          -  chest wall abnormalities&#xD;
&#xD;
          -  neurological disorders&#xD;
&#xD;
          -  septic status&#xD;
&#xD;
          -  chest skin infections&#xD;
&#xD;
          -  coagulopathies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierfrancesco Fusco, MDD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Salvatore Academic Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Salvatore Academic Hospital</name>
      <address>
        <city>Coppito</city>
        <state>L'Aquila</state>
        <zip>67100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 19, 2019</last_update_submitted>
  <last_update_submitted_qc>January 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Salvatore Hospital of L'Aquila</investigator_affiliation>
    <investigator_full_name>Emiliano Petrucci</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <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/NCT03016117
org study id: SanSalvatoreH
nct id: NCT03016117
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during
      quadrantectomy with or without axillary dissection, in breast cancer surgery
All patients receive Pecs II block and parasternal block, under ultrasound guidance. Pecs II
      block, performed at the 4th rib level, and parasternal block performed at the level of the
      2nd and 4th intercostal space level. Data on the anesthesia, side effects and pain, will be
      recorded
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anesthetic efficacy
time frame: The anesthetic efficacy was assessed in the first 72 hours, after block
description: The anesthetic efficacy is tested by cold and touch test
measure: Painkillers request
time frame: The painkillers request was assessed in the first 72 hours, after surgery
description: mg of morphine
measure: Side effects
time frame: The side effects recorded in the first 72 hours, after surgery
description: Nausea, vomiting, local anesthetic systemic toxicity
arm group label: Pecs II block and parasternal block
arm group type: Experimental
description: Pecs II block and parasternal block performed to provide anesthesia of breast, before of quadrantectomy with or without axillary dissection. Pecs II block performed at the 4th rib level and 20 ml of 0.5% Levobupivacaine injected, and parasternal block performed at the level of the 2nd and 4th intercostal space level, and 4 ml of 0.375% Levobupivacaine injected
intervention type: Procedure
intervention name: Pecs II block and parasternal block
description: The Pecs II block will be performed under ultrasound guidance, at fourth rib level, on the axillary line, into the fascial plane between pectoralis minor muscle and serratus muscle. The parasternal block will be performed under ultrasound guidance, at the second and fourth intercostal space, between the pectoralis major muscle and the intercostal muscles, near to the external intercostal membrane.
arm group label: Pecs II block and parasternal block
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Pierfrancesco Fusco, MDD
role: Principal Investigator
affiliation: San Salvatore Academic Hospital
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: San Salvatore Hospital of L'Aquila
investigator full name: Emiliano Petrucci
investigator title: MD
sharing ipd: No