<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/NCT03040167</url>
  </required_header>
  <id_info>
    <org_study_id>17.091</org_study_id>
    <nct_id>NCT03040167</nct_id>
  </id_info>
  <brief_title>The Pectoral Block for Breast Augmentation Surgery</brief_title>
  <acronym>BPCAM</acronym>
  <official_title>The Pectoral Block for Breast Augmentation Surgery: a Volunteers' and Patients' Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pierre Beaulieu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministere de la Sante et des Services Sociaux</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The pectoral block is a recently developed regional anesthetic technique that can be used for&#xD;
      the treatment of postoperative pain after breast surgery. Injection of local anesthetic&#xD;
      between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block.&#xD;
      This block has not been well characterized in terms of its blocking effects on motor and&#xD;
      sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). This clinical&#xD;
      trial is divided into two sections: a volunteer study and a patient study.&#xD;
&#xD;
      For the volunteer study, the aim is to assess the sensory territory affected by injection of&#xD;
      local anesthetics through a PEC 1 block and to assess motor function in terms of strength of&#xD;
      adduction of the affected limb using a dynamometer.&#xD;
&#xD;
      In a prospective, randomized, controlled and double blind study, the aim is to assess the&#xD;
      postoperative pain relieving properties of the PEC 1 block in patients undergoing bilateral&#xD;
      breast augmentation surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">March 29, 2018</completion_date>
  <primary_completion_date type="Actual">March 12, 2018</primary_completion_date>
  <phase>Phase 4</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>Postoperative pain score at rest</measure>
    <time_frame>Within the first 10 min after arrival to the postanesthesia care unit (PACU)</time_frame>
    <description>Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain score on movement</measure>
    <time_frame>Within the first 10 min after arrival to the postanesthesia care unit (PACU)</time_frame>
    <description>Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain score at rest</measure>
    <time_frame>15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU</time_frame>
    <description>Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of nausea and/or vomiting</measure>
    <time_frame>15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU</time_frame>
    <description>Presence or absence of nausea and/or vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical bleeding</measure>
    <time_frame>After surgery for 24 hours</time_frame>
    <description>Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematoma</measure>
    <time_frame>After surgery for 24 hours</time_frame>
    <description>Presence or absence of hematoma at PEC 1 block injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative well-being</measure>
    <time_frame>At 24 hours after surgery</time_frame>
    <description>Analgesic intake</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Anesthesia; Regional</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>PEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PEC 1 block with injection of 0.4 mL/kg of 0.25% bupivacaine with 1/400 000 epinephrine under echoguidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PEC 1 block</intervention_name>
    <description>Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>pectoral block</other_name>
    <other_name>pecblock</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine with epinephrine</intervention_name>
    <description>Treatment group</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Placebo group</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  breast augmentation surgery&#xD;
&#xD;
          -  registration at régie d'assurance maladie du Québec (RAMQ) (social services)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known bleeding disorder&#xD;
&#xD;
          -  anticoagulant intake&#xD;
&#xD;
          -  infection at site of PEC 1 block&#xD;
&#xD;
          -  pregnant or breast-feeding women&#xD;
&#xD;
          -  allergy to bupivacaine&#xD;
&#xD;
          -  chronic pain including fibromyalgia with regular analgesic consumption&#xD;
&#xD;
          -  under recreational drugs or alcohol at doses above canadian recommendations&#xD;
&#xD;
          -  muscle relaxants intake&#xD;
&#xD;
          -  patients already operated for breast augmentation or mastectomy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>CISSS des Laurentides</name>
      <address>
        <city>Saint Jérôme</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>December 7, 2019</last_update_submitted>
  <last_update_submitted_qc>December 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</investigator_affiliation>
    <investigator_full_name>Pierre Beaulieu</investigator_full_name>
    <investigator_title>Professor of anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 14, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03040167
org study id: 17.091
nct id: NCT03040167
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The pectoral block is a recently developed regional anesthetic technique that can be used for
      the treatment of postoperative pain after breast surgery. Injection of local anesthetic
      between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block.
      This block has not been well characterized in terms of its blocking effects on motor and
      sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). This clinical
      trial is divided into two sections: a volunteer study and a patient study.

      For the volunteer study, the aim is to assess the sensory territory affected by injection of
      local anesthetics through a PEC 1 block and to assess motor function in terms of strength of
      adduction of the affected limb using a dynamometer.

      In a prospective, randomized, controlled and double blind study, the aim is to assess the
      postoperative pain relieving properties of the PEC 1 block in patients undergoing bilateral
      breast augmentation surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Postoperative pain score at rest
time frame: Within the first 10 min after arrival to the postanesthesia care unit (PACU)
description: Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)
measure: Postoperative pain score on movement
time frame: Within the first 10 min after arrival to the postanesthesia care unit (PACU)
description: Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)
measure: Postoperative pain score at rest
time frame: 15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU
description: Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)
measure: Incidence of nausea and/or vomiting
time frame: 15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU
description: Presence or absence of nausea and/or vomiting
measure: Surgical bleeding
time frame: After surgery for 24 hours
description: Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration
measure: Hematoma
time frame: After surgery for 24 hours
description: Presence or absence of hematoma at PEC 1 block injection
measure: Postoperative well-being
time frame: At 24 hours after surgery
description: Analgesic intake
arm group label: Control group
arm group type: Placebo Comparator
description: PEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance.
arm group label: Treatment group
arm group type: Active Comparator
description: PEC 1 block with injection of 0.4 mL/kg of 0.25% bupivacaine with 1/400 000 epinephrine under echoguidance.
intervention type: Procedure
intervention name: PEC 1 block
description: Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.
arm group label: Control group
arm group label: Treatment group
other name: pectoral block
other name: pecblock
intervention type: Drug
intervention name: Bupivacaine with epinephrine
description: Treatment group
arm group label: Treatment group
intervention type: Drug
intervention name: Normal saline
description: Placebo group
arm group label: Control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
investigator full name: Pierre Beaulieu
investigator title: Professor of anesthesiology
mesh term: Pain, Postoperative
mesh term: Epinephrine
mesh term: Bupivacaine
sharing ipd: No
submitted: November 14, 2022