<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/NCT03043755</url>
  </required_header>
  <id_info>
    <org_study_id>ANECR_01_17</org_study_id>
    <nct_id>NCT03043755</nct_id>
  </id_info>
  <brief_title>PECS and Parasternal Block for Breast Surgery</brief_title>
  <acronym>PARAST</acronym>
  <official_title>Observational Study to Evaluated Efficacy of Parasternal and PECS Blocks Association in Breast Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituti Ospitalieri di Cremona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituti Ospitalieri di Cremona</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>
      Propose to evaluate efficacy of association between US guide parasternal block and pectorals&#xD;
      nerves block (PECS) as anesthetic option for breast surgery (medial quadrantectomy and simple&#xD;
      mastectomy).&#xD;
&#xD;
      All patients undergoing medial quadrantectomy and simple mastectomy in 6 months period will&#xD;
      be observed.&#xD;
&#xD;
      All patients receive: US guide parasternal block at T4 and T6 space with 6ml of ropivacaine&#xD;
      0,75% and PECS type 2 block performed with 24ml of ropivacaine 0,75%.&#xD;
&#xD;
      During surgery patients receive light sedation with continuous infusion of propofol&#xD;
&#xD;
      Will be observed:&#xD;
&#xD;
      Additional local anesthetic infiltration from surgeon. Pain at rest and during movement&#xD;
      quantified as Numerical Rating Scores (0-10) during the first 12 hours postoperatively.&#xD;
&#xD;
      Eventual side effects such as nausea/vomiting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Local Anesthetic infiltration</measure>
    <time_frame>intraoperatory period</time_frame>
    <description>Quantify amount of local anesthetic infiltration from surgeon to get perfect anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Convention in general anesthesia</measure>
    <time_frame>preoperative period</time_frame>
    <description>Number of patients require general anestesia to proceed to surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>12 hours postoperatively</time_frame>
    <description>Rest and in mouvement pain as NRS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PONV</measure>
    <time_frame>12 hours postoperatively</time_frame>
    <description>Postoperative nausea/vomiting incidence</description>
  </secondary_outcome>
  <enrollment type="Actual">32</enrollment>
  <condition>Quadrantectomy</condition>
  <condition>Mastectomy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing breast surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt; 18 years;&#xD;
&#xD;
          -  ASA score I - II - III;&#xD;
&#xD;
          -  undergoing elective medial quadrantectomy breast surgery;&#xD;
&#xD;
          -  undergoing elective mastectomy not reconstruction breast surgery;&#xD;
&#xD;
          -  signed informed consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic therapy with opioids/ antidepressants;&#xD;
&#xD;
          -  urgent/emergent surgery;&#xD;
&#xD;
          -  postoperative transfer to the intensive care unit;&#xD;
&#xD;
          -  known allergy to any drug medication;&#xD;
&#xD;
          -  local skin infection;&#xD;
&#xD;
          -  epilepsy;&#xD;
&#xD;
          -  alcohol or drug abuse;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ASST Cremona</name>
      <address>
        <city>Creom</city>
        <state>Cremona</state>
        <zip>26100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 3, 2017</last_update_submitted>
  <last_update_submitted_qc>February 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituti Ospitalieri di Cremona</investigator_affiliation>
    <investigator_full_name>Erika Basso Ricci</investigator_full_name>
    <investigator_title>Anesthetist</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/NCT03043755
org study id: ANECR_01_17
nct id: NCT03043755
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Propose to evaluate efficacy of association between US guide parasternal block and pectorals
      nerves block (PECS) as anesthetic option for breast surgery (medial quadrantectomy and simple
      mastectomy).

      All patients undergoing medial quadrantectomy and simple mastectomy in 6 months period will
      be observed.

      All patients receive: US guide parasternal block at T4 and T6 space with 6ml of ropivacaine
      0,75% and PECS type 2 block performed with 24ml of ropivacaine 0,75%.

      During surgery patients receive light sedation with continuous infusion of propofol

      Will be observed:

      Additional local anesthetic infiltration from surgeon. Pain at rest and during movement
      quantified as Numerical Rating Scores (0-10) during the first 12 hours postoperatively.

      Eventual side effects such as nausea/vomiting.
observational model: Cohort
time perspective: Prospective
measure: Local Anesthetic infiltration
time frame: intraoperatory period
description: Quantify amount of local anesthetic infiltration from surgeon to get perfect anesthesia
measure: Convention in general anesthesia
time frame: preoperative period
description: Number of patients require general anestesia to proceed to surgery
measure: Pain
time frame: 12 hours postoperatively
description: Rest and in mouvement pain as NRS scale
measure: PONV
time frame: 12 hours postoperatively
description: Postoperative nausea/vomiting incidence
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituti Ospitalieri di Cremona
investigator full name: Erika Basso Ricci
investigator title: Anesthetist
sharing ipd: No