<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/NCT04495504</url>
  </required_header>
  <id_info>
    <org_study_id>Pré-BLS-Sterno-RBHP 2018 ELJEZ</org_study_id>
    <nct_id>NCT04495504</nct_id>
  </id_info>
  <brief_title>Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery</brief_title>
  <acronym>Pre-BLS-Sterno</acronym>
  <official_title>The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      The sternotomy site is the most painful site after cardiac surgery. Local infiltration of&#xD;
      ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after&#xD;
      sternotomy significantly reduces pain at rest and during mobilization, reduces opioids&#xD;
      consumption, decreases postoperative complications, improves patient comfort and satisfaction&#xD;
      and reduced hospital costs. In this study our hypothesis is to test the efficacity of local&#xD;
      anesthetic administration via the catheters in the BLS position placed before the surgical&#xD;
      incision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Goal of the study: Evaluation of the effectiveness of BLS technique on a composite endpoint&#xD;
      (pain at rest, pain during patient mobilization and opioid consumption).&#xD;
&#xD;
      Open trial, therapeutic, prospective, monocentric. One group of patients who will benefits&#xD;
      from the placement of two multihole catheters in BLS position:&#xD;
&#xD;
        -  The ropivacaine group (40 patients): placement by the surgeon of two catheters in BLS&#xD;
           position before the surgical incision. Administration of a bolus dose of 10 ml of&#xD;
           ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine&#xD;
           2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.&#xD;
&#xD;
        -  The control group (80 patients) from the two previous studies who underwent standard&#xD;
           analgesia with PCA morphine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Actual">July 12, 2021</completion_date>
  <primary_completion_date type="Actual">January 12, 2021</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain evaluation</measure>
    <time_frame>Day 2 postoperatively.</time_frame>
    <description>The technique is considered as a fail if : pain rest &gt; 3.5 /10 (0 = no pain; 10 maximum pain) or pain during mobilization &gt; 3.5/10 (0 = no pain; 10 maximum pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>Day 2 postoperatively.</time_frame>
    <description>The technique is considered as a fail if morphine consumption &gt; 35 mg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Days of ICU and hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Days of ICU and hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Day 2 postoperatively.</time_frame>
    <description>Patient satisfaction evaluation from the patient based on a simple Likert scale:&#xD;
0 = very bad; 1 = bad; 2 = medium; 3 = good; 4 = excellent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting</measure>
    <time_frame>Day 1 and 2 postoperatively.</time_frame>
    <description>assessed by the Wengritzky intensity scale (if total score &gt; 50, the nausea and vomiting are clincally significant)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory complications</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Occurrence of postoperative respiratory complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac complications</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Occurrence of postoperative cardiac complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological complications</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Occurrence of postoperative neurological complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal,complications</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Occurrence of postoperative renal complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infectious complications</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Occurrence of postoperative infectious complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic pain evaluation</measure>
    <time_frame>Assessed at the 6th postoperative month</time_frame>
    <description>Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Scheduled Cardiac Surgery</condition>
  <condition>Age Under 85 Years</condition>
  <arm_group>
    <arm_group_label>Ropivacaine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of a bolus dose of ropivacaine, followed by a continuous infusion of ropivacaine during the first 48 hours postoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.</description>
    <arm_group_label>Ropivacaine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who undergo scheduled cardiac surgery with sternotomy: aortic or mitral valve&#xD;
             replacement, biological or mechanical, coronary bypass surgery&#xD;
&#xD;
          -  Age under 85 years&#xD;
&#xD;
          -  Patients who have given their consent according to the methods described in Title II&#xD;
             of the book of the first Public Health Code&#xD;
&#xD;
          -  Possession of Social Security insurance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Approach by thoracotomy&#xD;
&#xD;
          -  Heart transplant&#xD;
&#xD;
          -  Aortic dissection&#xD;
&#xD;
          -  Redo surgery.&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Refusal of the protocol&#xD;
&#xD;
          -  Protected minors or adults&#xD;
&#xD;
          -  Pre-existing psychiatric pathology including known states of opioid addiction&#xD;
&#xD;
          -  Long-term opioid medication&#xD;
&#xD;
          -  Physical or intellectual inability to use a PCA&#xD;
&#xD;
          -  Severe heart failure (ejection fraction less than 40% or PAH &gt; 50 mmHg)&#xD;
&#xD;
          -  Preoperative cardiogenic shock&#xD;
&#xD;
          -  Severe preoperative chronic or acute renal failure with a creatinine clearance of less&#xD;
             than 30 mL / min according to Cockroft's formula&#xD;
&#xD;
          -  Known hypersensitivity to local anesthetics or to any component of the catheter&#xD;
&#xD;
          -  Known allergy or hypersensitivity to any of the study drugs or analgesia protocol&#xD;
             (ropivacaine, paracetamol, opiates).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vedat Eljezi, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pôle Anesthésie Réanimation / Service de Chirurgie Cardio-Vasculaire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Puy De Dôme</state>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postoperative analgesia</keyword>
  <keyword>Sternotomy</keyword>
  <keyword>Local anesthetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04495504
org study id: Pré-BLS-Sterno-RBHP 2018 ELJEZ
nct id: NCT04495504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The sternotomy site is the most painful site after cardiac surgery. Local infiltration of
      ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after
      sternotomy significantly reduces pain at rest and during mobilization, reduces opioids
      consumption, decreases postoperative complications, improves patient comfort and satisfaction
      and reduced hospital costs. In this study our hypothesis is to test the efficacity of local
      anesthetic administration via the catheters in the BLS position placed before the surgical
      incision.
Goal of the study: Evaluation of the effectiveness of BLS technique on a composite endpoint
      (pain at rest, pain during patient mobilization and opioid consumption).

      Open trial, therapeutic, prospective, monocentric. One group of patients who will benefits
      from the placement of two multihole catheters in BLS position:

        -  The ropivacaine group (40 patients): placement by the surgeon of two catheters in BLS
           position before the surgical incision. Administration of a bolus dose of 10 ml of
           ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine
           2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.

        -  The control group (80 patients) from the two previous studies who underwent standard
           analgesia with PCA morphine.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
primary purpose: Treatment
masking: None (Open Label)
measure: Pain evaluation
time frame: Day 2 postoperatively.
description: The technique is considered as a fail if : pain rest > 3.5 /10 (0 = no pain; 10 maximum pain) or pain during mobilization > 3.5/10 (0 = no pain; 10 maximum pain)
measure: Opioid consumption
time frame: Day 2 postoperatively.
description: The technique is considered as a fail if morphine consumption > 35 mg
measure: ICU length of stay
time frame: Up to 6 months
description: Days of ICU and hospital stay
measure: Hospital length of stay
time frame: Up to 6 months
description: Days of ICU and hospital stay
measure: Patient satisfaction
time frame: Day 2 postoperatively.
description: Patient satisfaction evaluation from the patient based on a simple Likert scale:
0 = very bad; 1 = bad; 2 = medium; 3 = good; 4 = excellent.
measure: Postoperative nausea and vomiting
time frame: Day 1 and 2 postoperatively.
description: assessed by the Wengritzky intensity scale (if total score > 50, the nausea and vomiting are clincally significant)
measure: Respiratory complications
time frame: Up to 6 months
description: Occurrence of postoperative respiratory complications
measure: Cardiac complications
time frame: Up to 6 months
description: Occurrence of postoperative cardiac complications
measure: Neurological complications
time frame: Up to 6 months
description: Occurrence of postoperative neurological complications
measure: Renal,complications
time frame: Up to 6 months
description: Occurrence of postoperative renal complications
measure: Infectious complications
time frame: Up to 6 months
description: Occurrence of postoperative infectious complications
measure: Chronic pain evaluation
time frame: Assessed at the 6th postoperative month
description: Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score
arm group label: Ropivacaine group
arm group type: Experimental
description: Administration of a bolus dose of ropivacaine, followed by a continuous infusion of ropivacaine during the first 48 hours postoperatively.
intervention type: Drug
intervention name: Ropivacaine
description: Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
arm group label: Ropivacaine group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Vedat Eljezi, Dr
role: Principal Investigator
affiliation: Pôle Anesthésie Réanimation / Service de Chirurgie Cardio-Vasculaire
facility: 
country: France
responsible party type: Sponsor
mesh term: Ropivacaine