<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/NCT03754816</url>
  </required_header>
  <id_info>
    <org_study_id>0180910/16</org_study_id>
    <nct_id>NCT03754816</nct_id>
  </id_info>
  <brief_title>The Combination of PECS II Block and Parasternal Block for Radical Mastectomy</brief_title>
  <official_title>The Combination of PECS II Block and Parasternal Block Provide Useful Analgesia After Radical Mastectomy With Axillary Dissection and Implant Breast Reconstruction</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 combination of PECS II and parasternal Block provides analgesia after radical mastectomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The cambionation of PECS II block and parasternal block&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">April 12, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain: Numeric Rate Scale</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Postoperative pain evaluated with Numeric Rate Scale, from 0 (no pain) to 10 (worst pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative opiates</measure>
    <time_frame>From start to the end of surgery</time_frame>
    <description>Number of patients needing of equianalgesic mg of intraoperative morphine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative opiates</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Number of patients needing of equianalgesic mg of postoperative morphine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Number of patients with postoperative nausea and vomiting</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The combination of PECS II and parasternal block performed by injecting Levobupivacaine 0.375% 40 ml, injected between minor and major pectoralis muscles, between minor and serratus muscles and between major and intercostal muscles</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PECS II and parasternal block</intervention_name>
    <description>10 ml of Levobupivacaine 0.375% injected between minor and major pectoralis muscles. 20 ml of Levobupivacaine 0.375% injected between minor and serratus muscles. 10 ml of Levobupivacaine 0.375% injected between major and intercostal muscles at II and IV intercostal space.</description>
    <arm_group_label>Experimental group</arm_group_label>
    <other_name>Pectoral nerve block II type and parasternal block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine</intervention_name>
    <description>Levobupivacaine</description>
    <arm_group_label>Experimental group</arm_group_label>
    <other_name>Locali anesthetic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA status patients:1,2 and 3&#xD;
&#xD;
          -  patients undergoing to radical mastectomy with axillary dissection and breast-implant&#xD;
             reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with allergy to local anesthetics&#xD;
&#xD;
          -  ASA status patients: 4&#xD;
&#xD;
          -  breast anatomy abnormalities&#xD;
&#xD;
          -  neurological diseases&#xD;
&#xD;
          -  septic conditions&#xD;
&#xD;
          -  coagulopathies&#xD;
&#xD;
          -  drug abuse history&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emiliano Petrucci</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Salvatore Academic Hospital of L'Aquila</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>April 2019</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>PECS II block, parasternal block, analgesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Levobupivacaine</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/NCT03754816
org study id: 0180910/16
nct id: NCT03754816
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The combination of PECS II and parasternal Block provides analgesia after radical mastectomy
The cambionation of PECS II block and parasternal block
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Postoperative pain: Numeric Rate Scale
time frame: 24 hours after surgery
description: Postoperative pain evaluated with Numeric Rate Scale, from 0 (no pain) to 10 (worst pain)
measure: Intraoperative opiates
time frame: From start to the end of surgery
description: Number of patients needing of equianalgesic mg of intraoperative morphine
measure: Postoperative opiates
time frame: 24 hours after surgery
description: Number of patients needing of equianalgesic mg of postoperative morphine
measure: Side effects
time frame: 24 hours after surgery
description: Number of patients with postoperative nausea and vomiting
arm group label: Experimental group
arm group type: Experimental
description: The combination of PECS II and parasternal block performed by injecting Levobupivacaine 0.375% 40 ml, injected between minor and major pectoralis muscles, between minor and serratus muscles and between major and intercostal muscles
intervention type: Procedure
intervention name: PECS II and parasternal block
description: 10 ml of Levobupivacaine 0.375% injected between minor and major pectoralis muscles. 20 ml of Levobupivacaine 0.375% injected between minor and serratus muscles. 10 ml of Levobupivacaine 0.375% injected between major and intercostal muscles at II and IV intercostal space.
arm group label: Experimental group
other name: Pectoral nerve block II type and parasternal block
intervention type: Drug
intervention name: Levobupivacaine
description: Levobupivacaine
arm group label: Experimental group
other name: Locali anesthetic
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Emiliano Petrucci
role: Principal Investigator
affiliation: San Salvatore Academic Hospital of L'Aquila
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: San Salvatore Hospital of L'Aquila
investigator full name: Emiliano Petrucci
investigator title: Principal Investigator
mesh term: Anesthetics
mesh term: Levobupivacaine
sharing ipd: No