<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/NCT01670448</url>
  </required_header>
  <id_info>
    <org_study_id>CE12.231</org_study_id>
    <nct_id>NCT01670448</nct_id>
  </id_info>
  <brief_title>PECBLOCK for the Treatment of Pain After Breast Surgery</brief_title>
  <acronym>PECBLOC</acronym>
  <official_title>The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain after breast cancer surgery could be severe and about 1/3 of patients will develop&#xD;
      chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral&#xD;
      muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of&#xD;
      this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor&#xD;
      and major breast surgery. The prevention of chronic pain following surgery will also be&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score at rest in the recovery room</measure>
    <time_frame>30 min after entering the recovery room or just before morphine administration if needed</time_frame>
    <description>Using a 0-10 verbal numerical scale where 0 is no pain and 10 the worst pain imaginable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total morphine consumption in the recovery room</measure>
    <time_frame>in the recovery room before discharge (after 1 h on average))</time_frame>
    <description>When surgery is over and the patient is brought to the recovery room, the total morphine consumption in mg used in the recovery (for pain less than 4/10) is recorded</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total sufentanil consumption during surgery</measure>
    <time_frame>at the end of surgery (1-2 h on average)</time_frame>
    <description>When surgery is over, 1-2 h on average depending if it is a tumorectomy or a mastectomy, the total sufentanil consumption in micrograms during surgery is recorded.</description>
  </other_outcome>
  <other_outcome>
    <measure>Assess any complication from PECBLOCK</measure>
    <time_frame>first 24 hours post surgery</time_frame>
    <description>Cardiovascular collapse, anaphylactic shock, hematoma, bleeding..?</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Cancer</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>PECBLOCK performed with bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active drug given through PECBLOCK in these patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PECBLOCK performed with NaCl 0.9%</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo drug given through PECBLOCK in these patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PECBLOCK under echoguidance</intervention_name>
    <description>Performance of block under echography</description>
    <arm_group_label>PECBLOCK performed with NaCl 0.9%</arm_group_label>
    <arm_group_label>PECBLOCK performed with bupivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women aged 18-85 yrs old&#xD;
&#xD;
          -  patients ASA status I-IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of the PECBLOCK&#xD;
&#xD;
          -  allergy to a drug used in the protocol (local anesthetic)&#xD;
&#xD;
          -  patients with chronic pain before the surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jérôme Cros, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Limoges</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre Beaulieu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHUM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHUM</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2W 1T8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital, Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postoperative pain</keyword>
  <keyword>Chronic pain prevention</keyword>
  <keyword>Regional anesthesia</keyword>
  <keyword>Mastectomy</keyword>
  <!-- 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/NCT01670448
org study id: CE12.231
nct id: NCT01670448
lead sponsor: 
collaborator: 
has dmc: Yes
Pain after breast cancer surgery could be severe and about 1/3 of patients will develop
      chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral
      muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of
      this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor
      and major breast surgery. The prevention of chronic pain following surgery will also be
      evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain score at rest in the recovery room
time frame: 30 min after entering the recovery room or just before morphine administration if needed
description: Using a 0-10 verbal numerical scale where 0 is no pain and 10 the worst pain imaginable
measure: Total morphine consumption in the recovery room
time frame: in the recovery room before discharge (after 1 h on average))
description: When surgery is over and the patient is brought to the recovery room, the total morphine consumption in mg used in the recovery (for pain less than 4/10) is recorded
measure: Total sufentanil consumption during surgery
time frame: at the end of surgery (1-2 h on average)
description: When surgery is over, 1-2 h on average depending if it is a tumorectomy or a mastectomy, the total sufentanil consumption in micrograms during surgery is recorded.
measure: Assess any complication from PECBLOCK
time frame: first 24 hours post surgery
description: Cardiovascular collapse, anaphylactic shock, hematoma, bleeding..?
arm group label: PECBLOCK performed with bupivacaine
arm group type: Active Comparator
description: Active drug given through PECBLOCK in these patients.
arm group label: PECBLOCK performed with NaCl 0.9%
arm group type: Placebo Comparator
description: Placebo drug given through PECBLOCK in these patients
intervention type: Procedure
intervention name: PECBLOCK under echoguidance
description: Performance of block under echography
arm group label: PECBLOCK performed with NaCl 0.9%
arm group label: PECBLOCK performed with bupivacaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jérôme Cros, MD
role: Principal Investigator
affiliation: CHU Limoges
last name: Pierre Beaulieu, MD
role: Principal Investigator
affiliation: CHUM
facility: 
facility: 
country: Canada
country: France
responsible party type: Sponsor