<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/NCT03811262</url>
  </required_header>
  <id_info>
    <org_study_id>ESPvsPECS/AOP</org_study_id>
    <nct_id>NCT03811262</nct_id>
  </id_info>
  <brief_title>Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery</brief_title>
  <official_title>Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery:a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Padova</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>
      Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in&#xD;
      perioperative period.&#xD;
&#xD;
      PECS II block is an interfascial block that has been used widely as regional anesthesia&#xD;
      technique in breast surgery.&#xD;
&#xD;
      ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this&#xD;
      technique in breast surgery to provide analgesia but to date no studies comparing these&#xD;
      technique exists.&#xD;
&#xD;
      Our hypotesis is that this two technique are equally able to provide analgesia in breast&#xD;
      surgery.&#xD;
&#xD;
      Study type: RCT, single blind.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Logistic reasons (Operating room performing the surgery investigated moved to another&#xD;
    structure)&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2022</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</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>
    <intervention_model_description>This is a single-centre, prospective; double blinded randomised interventional clinical trial.&#xD;
Patients will be randomly allocated to group &quot;PECS&quot; or &quot;ESP&quot; using a closed envelope technique.&#xD;
Group &quot;PECS&quot; will receive PECS II block as described by Blanco using 30 ml Levobupivacaine 0.25% Group &quot;ESP&quot; will receive ESP block as described by forero using 30 ml Levobupivacaine 0.25% at T5 level.&#xD;
Blocks will be executed after general anesthesia induction. All partecipants will receive Fentanyl 2 mcg/kg and Propofol 2 mg/kg for induction. Anesthesia will be mantained with Propofol to obtain a BIS level between 40-50. Patients will receive Fentanyl 33 mcg whenever blood pressure and/or hear rate raise more than 20% from baseline after surgical stimulation. At the end of the surgery patients will receive acetominophen 1 g. postoperative therapy: acetominophen 1g/8hr and ketoprofen 100 mg/12hr.&#xD;
Patients will receive 2 mg Morphine whenever a NRS &gt; 3.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>ESP block and PECS block will be executed by an anesthesiologist that will not follow the patient during the surgery.&#xD;
Anesthesiologist responsible for the surgery will be not aware of the block executed on the patient Anesthesiologist and surgeon responsible for postoperative therapy will be not aware of the block executed on the patient</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative Fentanyl consumption</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NRS at 6 hour</measure>
    <time_frame>sixth postoperative hour</time_frame>
    <description>NRS (0-10) difference at sixth postoperative hour between ESP group and PECS group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS at 12 hour</measure>
    <time_frame>twelth postoperative hour</time_frame>
    <description>NRS (0-10) difference at twelth postoperative hour between ESP group and PECS group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS at 24 hour</measure>
    <time_frame>twentyfourth postoperative hour</time_frame>
    <description>NRS (0-10) difference at twentyfourth postoperative hour between ESP group and PECS group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction at 24 hour</measure>
    <time_frame>postoperative period (24h)</time_frame>
    <description>Patient satisfaction (0-10) difference regarding anesthesia management at twentyfourth postoperative hour between ESP group and PECS group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first opioid consumption in the postoperative period</measure>
    <time_frame>postoperative period (24h)</time_frame>
    <description>Time (minutes) to first opioid consumption in the postoperative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative morphine consumption</measure>
    <time_frame>postoperative period (24h)</time_frame>
    <description>postoperative morphine dose (mg) difference between ESP group and PECS group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea and vomit incidence</measure>
    <time_frame>postoperative period (24h)</time_frame>
    <description>Incidence of nausea and vomiting in postoperative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other complication incidence</measure>
    <time_frame>postoperative period (24h)</time_frame>
    <description>Incidence of other complcations linked to anesthesia in postoperative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Fentanyl consumption(mcg/kg/h)</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Intraoperative fentanyl dose (mcg/kg/h) difference between ESP group and PECS group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>ESP BLOCK</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention:30 ml of 0.25% Levobupivacaine where: ESP block as described by Forero at T5 level (single injection between transversour process and erector spinae muscles)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PECS block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ESP BLOCK</intervention_name>
    <description>local anesthetic will be injected between transverous process and erector spinae muscle</description>
    <arm_group_label>ESP BLOCK</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PECS BLOCK</intervention_name>
    <description>local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)</description>
    <arm_group_label>PECS block</arm_group_label>
    <other_name>30 ml 0.25% Levobupivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mastectomy program with axillary clearence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral surgery&#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>Alessandro De Cassai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Padova</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Padova</investigator_affiliation>
    <investigator_full_name>Alessandro De Cassai</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>PECS</keyword>
  <keyword>ESP</keyword>
  <keyword>RCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levobupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Probably data will be shared at the end of the study</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/NCT03811262
org study id: ESPvsPECS/AOP
nct id: NCT03811262
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in
      perioperative period.

      PECS II block is an interfascial block that has been used widely as regional anesthesia
      technique in breast surgery.

      ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this
      technique in breast surgery to provide analgesia but to date no studies comparing these
      technique exists.

      Our hypotesis is that this two technique are equally able to provide analgesia in breast
      surgery.

      Study type: RCT, single blind.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a single-centre, prospective; double blinded randomised interventional clinical trial.
Patients will be randomly allocated to group "PECS" or "ESP" using a closed envelope technique.
Group "PECS" will receive PECS II block as described by Blanco using 30 ml Levobupivacaine 0.25% Group "ESP" will receive ESP block as described by forero using 30 ml Levobupivacaine 0.25% at T5 level.
Blocks will be executed after general anesthesia induction. All partecipants will receive Fentanyl 2 mcg/kg and Propofol 2 mg/kg for induction. Anesthesia will be mantained with Propofol to obtain a BIS level between 40-50. Patients will receive Fentanyl 33 mcg whenever blood pressure and/or hear rate raise more than 20% from baseline after surgical stimulation. At the end of the surgery patients will receive acetominophen 1 g. postoperative therapy: acetominophen 1g/8hr and ketoprofen 100 mg/12hr.
Patients will receive 2 mg Morphine whenever a NRS > 3.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: ESP block and PECS block will be executed by an anesthesiologist that will not follow the patient during the surgery.
Anesthesiologist responsible for the surgery will be not aware of the block executed on the patient Anesthesiologist and surgeon responsible for postoperative therapy will be not aware of the block executed on the patient
measure: Intraoperative Fentanyl consumption
time frame: Intraoperative
description: Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group.
measure: NRS at 6 hour
time frame: sixth postoperative hour
description: NRS (0-10) difference at sixth postoperative hour between ESP group and PECS group
measure: NRS at 12 hour
time frame: twelth postoperative hour
description: NRS (0-10) difference at twelth postoperative hour between ESP group and PECS group
measure: NRS at 24 hour
time frame: twentyfourth postoperative hour
description: NRS (0-10) difference at twentyfourth postoperative hour between ESP group and PECS group
measure: Patient satisfaction at 24 hour
time frame: postoperative period (24h)
description: Patient satisfaction (0-10) difference regarding anesthesia management at twentyfourth postoperative hour between ESP group and PECS group
measure: Time to first opioid consumption in the postoperative period
time frame: postoperative period (24h)
description: Time (minutes) to first opioid consumption in the postoperative period
measure: Postoperative morphine consumption
time frame: postoperative period (24h)
description: postoperative morphine dose (mg) difference between ESP group and PECS group.
measure: Nausea and vomit incidence
time frame: postoperative period (24h)
description: Incidence of nausea and vomiting in postoperative period
measure: Other complication incidence
time frame: postoperative period (24h)
description: Incidence of other complcations linked to anesthesia in postoperative period
measure: Intraoperative Fentanyl consumption(mcg/kg/h)
time frame: Intraoperative
description: Intraoperative fentanyl dose (mcg/kg/h) difference between ESP group and PECS group.
arm group label: ESP BLOCK
arm group type: Active Comparator
description: Intervention:30 ml of 0.25% Levobupivacaine where: ESP block as described by Forero at T5 level (single injection between transversour process and erector spinae muscles)
arm group label: PECS block
arm group type: Active Comparator
description: Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco.
intervention type: Procedure
intervention name: ESP BLOCK
description: local anesthetic will be injected between transverous process and erector spinae muscle
arm group label: ESP BLOCK
intervention type: Procedure
intervention name: PECS BLOCK
description: local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)
arm group label: PECS block
other name: 30 ml 0.25% Levobupivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Alessandro De Cassai, MD
role: Principal Investigator
affiliation: Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Padova
investigator full name: Alessandro De Cassai
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Levobupivacaine
sharing ipd: Undecided
ipd description: Probably data will be shared at the end of the study