<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/NCT04443894</url>
  </required_header>
  <id_info>
    <org_study_id>BreastPecs</org_study_id>
    <nct_id>NCT04443894</nct_id>
  </id_info>
  <brief_title>Acute &amp; Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?</brief_title>
  <official_title>Acute &amp; Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Attikon Hospital</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>
      Post mastectomy pain management is of crucial importance for patients' rehabilitation and&#xD;
      quality of life. PECS block is used for acute and chronic post mastectomy pain management.&#xD;
      Surgical infiltration is also used in this field. Patients in our study are divided in two&#xD;
      groups receiving PECS block or surgical infiltrationbefore incision. Multimodal analgesia is&#xD;
      indispensable according to recent guidelines for enhanced postoperative recovery. Pain scores&#xD;
      will be assessed during the first 24h postoperatively and at 3 months after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are randomly assigned to 2 groups, PECS block or surgical infiltration group.&#xD;
      Patients assigned to PECS group will receive 30cc of ropivacaine 0,375% where 10cc will be&#xD;
      injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and&#xD;
      serratus anterior muscle under ultrasound guidance. Patients assigned to surgical&#xD;
      infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. Local&#xD;
      aneshetic is administered in both groups after the induction of general anesthesia and before&#xD;
      incision. Pain will be assessed at 1, 12, 24h after surgery and at three months after surgery&#xD;
      communicating by telephone. Post operative analgesia includes paracetamol 1gr, parecoxib 40&#xD;
      mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). Chronic&#xD;
      pain will be assessed after 3 months as for prevalence and neuropathic characteristics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>PATIENT OUTCOME ASSESSOR</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>intensity of acute postoperative pain</measure>
    <time_frame>24 hours</time_frame>
    <description>intensity of acute postoperative pain, numeric rating scale 0-10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intensity of chronic pain</measure>
    <time_frame>3 months</time_frame>
    <description>intensity of chronic pain with numeric rating scale 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of chronic neuropathic pain</measure>
    <time_frame>3 months</time_frame>
    <description>Prevalence of chronic pain at the site of surgery, measured with the LANSS questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of chronic neuropathic pain</measure>
    <time_frame>3 months</time_frame>
    <description>Prevalence of chronic pain at the site of surgery, measured with YES./NO</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration</condition>
  <arm_group>
    <arm_group_label>PECS block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>local infiltration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PECS block</intervention_name>
    <description>PECS block is performed at the side of surgery (II) before incision with ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).</description>
    <arm_group_label>PECS block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>local infiltration</intervention_name>
    <description>local infiltration of the surgical wound before incision with πwith ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).</description>
    <arm_group_label>local infiltration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 18 years of age&#xD;
&#xD;
          -  ASA physical status I-III&#xD;
&#xD;
          -  elective partial mastectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of patient participation or inability to participate to the study&#xD;
&#xD;
               -  known allergic reaction to drugs included in the study design&#xD;
&#xD;
               -  contraindiations of performance of peripheral regional anesthesia&#xD;
&#xD;
               -  diabetes melitus or known neurological disorder&#xD;
&#xD;
               -  chronic pain disorders under therapy with opioids or other analgesic drugs for&#xD;
                  chronic pain&#xD;
&#xD;
               -  all male patients&#xD;
&#xD;
               -  all patients not speaking the Greek language&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>only women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eleftheria Soulioti, MD,PhD</last_name>
    <phone>00306946745366</phone>
    <email>eleftheriasoulioti@ymail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chrysanthi Batistaki, MD,PhD</last_name>
    <phone>00302105832371</phone>
    <email>chrysabatistaki@yahoo.gr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.</name>
      <address>
        <city>Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chrysanthi Batistaki, MD, PhD</last_name>
      <phone>0030 210 5832371</phone>
      <email>chrysabatistaki@yahoo.gr</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 21, 2020</last_update_submitted>
  <last_update_submitted_qc>June 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Chrysanthi Batistaki</investigator_full_name>
    <investigator_title>Associate Professor of Anaesthesiology</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>mastectomy</keyword>
  <keyword>PECS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_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/NCT04443894
org study id: BreastPecs
nct id: NCT04443894
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post mastectomy pain management is of crucial importance for patients' rehabilitation and
      quality of life. PECS block is used for acute and chronic post mastectomy pain management.
      Surgical infiltration is also used in this field. Patients in our study are divided in two
      groups receiving PECS block or surgical infiltrationbefore incision. Multimodal analgesia is
      indispensable according to recent guidelines for enhanced postoperative recovery. Pain scores
      will be assessed during the first 24h postoperatively and at 3 months after surgery.
Patients are randomly assigned to 2 groups, PECS block or surgical infiltration group.
      Patients assigned to PECS group will receive 30cc of ropivacaine 0,375% where 10cc will be
      injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and
      serratus anterior muscle under ultrasound guidance. Patients assigned to surgical
      infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. Local
      aneshetic is administered in both groups after the induction of general anesthesia and before
      incision. Pain will be assessed at 1, 12, 24h after surgery and at three months after surgery
      communicating by telephone. Post operative analgesia includes paracetamol 1gr, parecoxib 40
      mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). Chronic
      pain will be assessed after 3 months as for prevalence and neuropathic characteristics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: PATIENT OUTCOME ASSESSOR
measure: intensity of acute postoperative pain
time frame: 24 hours
description: intensity of acute postoperative pain, numeric rating scale 0-10
measure: intensity of chronic pain
time frame: 3 months
description: intensity of chronic pain with numeric rating scale 0-10
measure: Prevalence of chronic neuropathic pain
time frame: 3 months
description: Prevalence of chronic pain at the site of surgery, measured with the LANSS questionnaire
measure: Prevalence of chronic neuropathic pain
time frame: 3 months
description: Prevalence of chronic pain at the site of surgery, measured with YES./NO
arm group label: PECS block
arm group type: Active Comparator
arm group label: local infiltration
arm group type: Active Comparator
intervention type: Other
intervention name: PECS block
description: PECS block is performed at the side of surgery (II) before incision with ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).
arm group label: PECS block
intervention type: Other
intervention name: local infiltration
description: local infiltration of the surgical wound before incision with πwith ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).
arm group label: local infiltration
criteria: 
gender: Female
gender based: Yes
gender description: only women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eleftheria Soulioti, MD,PhD
phone: 00306946745366
email: eleftheriasoulioti@ymail.com
last name: Chrysanthi Batistaki, MD,PhD
phone: 00302105832371
email: chrysabatistaki@yahoo.gr
facility: 
status: Recruiting
contact: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Attikon Hospital
investigator full name: Chrysanthi Batistaki
investigator title: Associate Professor of Anaesthesiology
mesh term: Chronic Pain
sharing ipd: No