<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/NCT03023007</url>
  </required_header>
  <id_info>
    <org_study_id>PECS-1601</org_study_id>
    <secondary_id>N°IdRCB : N°2016-A00562-49</secondary_id>
    <nct_id>NCT03023007</nct_id>
  </id_info>
  <brief_title>Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on Chronic Pain of a Mastectomy</brief_title>
  <acronym>PECS</acronym>
  <official_title>Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on the Rate of Chronic Pains 6 Month After a Mastectomy Associated or Not With Axillary Node Dissection and/or a Reconstruction Prosthesis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Oscar Lambret</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Oscar Lambret</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>
      A non-randomized, mono-centric, prospective interventional study that will assess the&#xD;
      efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a&#xD;
      patient will have either received a mastectomy or a mastectomy associated with axillary nodes&#xD;
      dissection, and/or a reconstruction by prosthesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to assess the care given to treat breast cancer while the patient&#xD;
      receives a total mastectomy. It is done by evaluating the technique of anesthesia PECS used&#xD;
      during this procedure so that the rate of chronic pain can be measured 6 month after the&#xD;
      operation.&#xD;
&#xD;
      As well as total mastectomy, patients are also eligible for an axillary lymph node dissection&#xD;
      (ALND) and a reconstruction of the breast by prosthesis as options.&#xD;
&#xD;
      Other objectives of the study include:&#xD;
&#xD;
        -  Evaluating the effectiveness of the PECS anesthesia technique on the trajectory of acute&#xD;
           post-operative pain and on chronic pain after 12 month of the surgery&#xD;
&#xD;
        -  Evaluating the type and intensity of the pain&#xD;
&#xD;
        -  Evaluating the quality of life&#xD;
&#xD;
        -  Study the link between chronic pain and the trajectory of acute pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">August 22, 2019</completion_date>
  <primary_completion_date type="Actual">February 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of chronic pain</measure>
    <time_frame>6 month after surgery</time_frame>
    <description>The rate of chronic pain will be assessed in percentage (%) based on the criteria of the International Association for the Study Pain (IASP) during an algology medical consultation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute post-operative pain</measure>
    <time_frame>During the 3 days following the surgery</time_frame>
    <description>A representation of the trajectory of pain in the 3 days will be drawn. This pain trajectory is defined as the kinetics of the average daily visual analog scale (VAS) score for 3 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects post-operative</measure>
    <time_frame>During the 3 days following the surgery</time_frame>
    <description>All side effects (e.g. nausea, vomiting etc.) will be recorded, with its date, time, severity, relation with the treatment, treatment associated and evolution. The intensity of adverse events will be scored using the criteria from NCI-CTCAE version 4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of chronic pain</measure>
    <time_frame>12 month after the surgery</time_frame>
    <description>Assessed based on the criteria of the International Association for the Study Pain (IASP) collected via telephone call.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of chronic pain</measure>
    <time_frame>6 and 12 month after surgery</time_frame>
    <description>The type of chronic pain will be determined using the DN4 score. The DN4 score is a form used for the diagnostic of neuropathic pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of chronic pain</measure>
    <time_frame>6 and 12 month after surgery</time_frame>
    <description>The intensity of the pain will be recorded using the visual analog scale (VAS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>predictive factors of survival</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>Using the proportional hazards model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of the patient assessed with the QLQ-C30 questionnaire</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>QLQ-C30 from the EORTC (quality of life in general, physical condition, limitations to activities, cognitive functions, emotional and social and symptoms occurrences related to cancer or the treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of the patient assessed with the QLQ-BR23 questionnaire</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>QLQ-BR23 (body image, perception of the future etc. and side effects)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression assessed with the HADS questionnaire</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>HADS (Hospital Anxiety and Depression Scale) : to detect anxiety and depression</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Prediction of the post-operative chronic pain with Kalkman score</measure>
    <time_frame>within the 15 days before the surgery</time_frame>
    <description>The Kalkman score is a validated risk scale based on patient's history and the type of surgery</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Breastcancer</condition>
  <condition>Mastectomy</condition>
  <arm_group>
    <arm_group_label>Loco-regional anaesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Loco-regional anaesthesia Anesthesia technique used : loco-regional PECS for patients requiring Mastectomy; And/or Axillary node dissection ; And/or Reconstruction of breast by prosthesis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Loco-regional anaesthesia</intervention_name>
    <description>Loco-regional anaesthesia</description>
    <arm_group_label>Loco-regional anaesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with unilateral breast cancer&#xD;
&#xD;
          -  Surgery must be a total mastectomy +/- axillary lymph node dissection and +/-&#xD;
             reconstruction by prosthesis; unless first surgery was performed more than 5 years&#xD;
             prior to total mastectomy without any residual pain&#xD;
&#xD;
          -  Age ≥ 18 ans&#xD;
&#xD;
          -  Non-opposition of patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reconstruction by other than prosthesis&#xD;
&#xD;
          -  Previous breast surgery in the last year&#xD;
&#xD;
          -  Hypersensitivity or allergy of anaesthetics&#xD;
&#xD;
          -  Coagulopathy and local infections&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Patients under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abesse AHMEIDI, MD</last_name>
    <role>Study Director</role>
    <affiliation>Département Anesthésie /Algologie, Centre Oscar Lambret</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>November 18, 2022</last_update_submitted>
  <last_update_submitted_qc>November 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT03023007
org study id: PECS-1601
secondary id: N°IdRCB : N°2016-A00562-49
nct id: NCT03023007
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A non-randomized, mono-centric, prospective interventional study that will assess the
      efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a
      patient will have either received a mastectomy or a mastectomy associated with axillary nodes
      dissection, and/or a reconstruction by prosthesis.
The aim of this study is to assess the care given to treat breast cancer while the patient
      receives a total mastectomy. It is done by evaluating the technique of anesthesia PECS used
      during this procedure so that the rate of chronic pain can be measured 6 month after the
      operation.

      As well as total mastectomy, patients are also eligible for an axillary lymph node dissection
      (ALND) and a reconstruction of the breast by prosthesis as options.

      Other objectives of the study include:

        -  Evaluating the effectiveness of the PECS anesthesia technique on the trajectory of acute
           post-operative pain and on chronic pain after 12 month of the surgery

        -  Evaluating the type and intensity of the pain

        -  Evaluating the quality of life

        -  Study the link between chronic pain and the trajectory of acute pain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of chronic pain
time frame: 6 month after surgery
description: The rate of chronic pain will be assessed in percentage (%) based on the criteria of the International Association for the Study Pain (IASP) during an algology medical consultation.
measure: Acute post-operative pain
time frame: During the 3 days following the surgery
description: A representation of the trajectory of pain in the 3 days will be drawn. This pain trajectory is defined as the kinetics of the average daily visual analog scale (VAS) score for 3 days.
measure: Side effects post-operative
time frame: During the 3 days following the surgery
description: All side effects (e.g. nausea, vomiting etc.) will be recorded, with its date, time, severity, relation with the treatment, treatment associated and evolution. The intensity of adverse events will be scored using the criteria from NCI-CTCAE version 4.0.
measure: Rate of chronic pain
time frame: 12 month after the surgery
description: Assessed based on the criteria of the International Association for the Study Pain (IASP) collected via telephone call.
measure: Type of chronic pain
time frame: 6 and 12 month after surgery
description: The type of chronic pain will be determined using the DN4 score. The DN4 score is a form used for the diagnostic of neuropathic pain.
measure: Intensity of chronic pain
time frame: 6 and 12 month after surgery
description: The intensity of the pain will be recorded using the visual analog scale (VAS).
measure: predictive factors of survival
time frame: an average of 1 year
description: Using the proportional hazards model.
measure: Quality of life of the patient assessed with the QLQ-C30 questionnaire
time frame: an average of 1 year
description: QLQ-C30 from the EORTC (quality of life in general, physical condition, limitations to activities, cognitive functions, emotional and social and symptoms occurrences related to cancer or the treatment)
measure: Quality of life of the patient assessed with the QLQ-BR23 questionnaire
time frame: an average of 1 year
description: QLQ-BR23 (body image, perception of the future etc. and side effects)
measure: Depression assessed with the HADS questionnaire
time frame: an average of 1 year
description: HADS (Hospital Anxiety and Depression Scale) : to detect anxiety and depression
measure: Prediction of the post-operative chronic pain with Kalkman score
time frame: within the 15 days before the surgery
description: The Kalkman score is a validated risk scale based on patient's history and the type of surgery
arm group label: Loco-regional anaesthesia
arm group type: Experimental
description: Loco-regional anaesthesia Anesthesia technique used : loco-regional PECS for patients requiring Mastectomy; And/or Axillary node dissection ; And/or Reconstruction of breast by prosthesis
intervention type: Procedure
intervention name: Loco-regional anaesthesia
description: Loco-regional anaesthesia
arm group label: Loco-regional anaesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abesse AHMEIDI, MD
role: Study Director
affiliation: Département Anesthésie /Algologie, Centre Oscar Lambret
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Chronic Pain
mesh term: Anesthetics
sharing ipd: No