<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/NCT01698203</url>
  </required_header>
  <id_info>
    <org_study_id>5277</org_study_id>
    <nct_id>NCT01698203</nct_id>
  </id_info>
  <brief_title>Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy</brief_title>
  <official_title>Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia: Continuous Wound Catheter Analgesia Associated With Intravenous Morphine Patient-Controlled-Analgesia (PCA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is&#xD;
      contraindicated in certain patients. An alternative is continuous wound catheter analgesia.&#xD;
      We will investigate whether ropivacaine, administered through a wound catheter placed by the&#xD;
      surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult&#xD;
      patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be&#xD;
      randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75%&#xD;
      ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or&#xD;
      saline at the same scheme of administration. Patients will also benefit from&#xD;
      patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min),&#xD;
      paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary&#xD;
      endpoints will be pain intensity on a visual analog scale at rest and on coughing and side&#xD;
      effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the&#xD;
      nurses and caring staff involved in this study will be blinded. Solutions of saline and&#xD;
      ropivacaine will be prepared identically by the central pharmacy, without any possible&#xD;
      identification of the product.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 14, 2012</start_date>
  <completion_date type="Actual">October 11, 2018</completion_date>
  <primary_completion_date type="Actual">October 14, 2012</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total intravenous morphine consumption (mg)</measure>
    <time_frame>the first 48 hours after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Pain</condition>
  <condition>Thoracotomy</condition>
  <arm_group>
    <arm_group_label>ropivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)</intervention_name>
    <description>The group ropivacaine, an initial bolus of 0.75% ropivacaine at a volume of 0.1 ml / kg is first administered to the patient directly on the catheter.</description>
    <arm_group_label>ropivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>In the placebo group, an initial bolus of saline 9 ‰ to a volume of 0.1 ml / kg will first be administered to the patient directly to the catheter. The patient will then continuous administration of saline 9 ‰ during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled of this solution, a flow rate of 9.53 ml / hour.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)</intervention_name>
    <description>The patient will then ongoing administration of ropivacaine 0.2% during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled (B Braun) of this solution, a flow rate of 9.53 ml / hour</description>
    <arm_group_label>ropivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients scheduled for thoracotomy who presented with contraindications to TEA.&#xD;
&#xD;
        Contraindications to TEA are :&#xD;
&#xD;
          -  Patient's refusal after informations about advantages and risks of the technique&#xD;
&#xD;
          -  Anti platelets treatment that can't be discontinued&#xD;
&#xD;
          -  Anticoagulants at a curative dosage&#xD;
&#xD;
          -  haemostasis and/or coagulation disorders: thrombopenia &lt; 100.000/mm3, ACT &gt; 1,5 /&#xD;
             control, PTT &lt; 75%&#xD;
&#xD;
          -  Systemic or local infection of the puncture point&#xD;
&#xD;
          -  2 and 3 grade atrio-ventricular heart block without pacing&#xD;
&#xD;
          -  Severe aortic valve stenosis&#xD;
&#xD;
          -  Kyphoscoliosis&#xD;
&#xD;
          -  certain neurological disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's refusal to participate in the study&#xD;
&#xD;
          -  Psychiatric disorder (impossibility to collect the informed consent)&#xD;
&#xD;
          -  Patient under juridical protection&#xD;
&#xD;
          -  On going an other study&#xD;
&#xD;
          -  Pregnancy, breastfeeding&#xD;
&#xD;
          -  Non balanced epilepsy&#xD;
&#xD;
          -  3 grade auriculo-ventricular heart block without pacing&#xD;
&#xD;
          -  Severe hepatocellular insufficiency&#xD;
&#xD;
          -  Anti arrhythmic treatment : class III of the Vaughan William's classification&#xD;
&#xD;
          -  Skin infection of the puncture point&#xD;
&#xD;
          -  Allergy to aminoamides local anaesthetic&#xD;
&#xD;
          -  Surgical difficulties to insert paravertebral catheter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier Helms, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Civil - NHC Département d'Anesthésiologie</name>
      <address>
        <city>STRASBOURG Cedex</city>
        <state>Alsace</state>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01698203
org study id: 5277
nct id: NCT01698203
lead sponsor: 
has dmc: No
Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is
      contraindicated in certain patients. An alternative is continuous wound catheter analgesia.
      We will investigate whether ropivacaine, administered through a wound catheter placed by the
      surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult
      patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be
      randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75%
      ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or
      saline at the same scheme of administration. Patients will also benefit from
      patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min),
      paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary
      endpoints will be pain intensity on a visual analog scale at rest and on coughing and side
      effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the
      nurses and caring staff involved in this study will be blinded. Solutions of saline and
      ropivacaine will be prepared identically by the central pharmacy, without any possible
      identification of the product.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Total intravenous morphine consumption (mg)
time frame: the first 48 hours after surgery
arm group label: ropivacaine
arm group type: Experimental
arm group label: placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)
description: The group ropivacaine, an initial bolus of 0.75% ropivacaine at a volume of 0.1 ml / kg is first administered to the patient directly on the catheter.
arm group label: ropivacaine
intervention type: Drug
intervention name: Placebo
description: In the placebo group, an initial bolus of saline 9 ‰ to a volume of 0.1 ml / kg will first be administered to the patient directly to the catheter. The patient will then continuous administration of saline 9 ‰ during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled of this solution, a flow rate of 9.53 ml / hour.
arm group label: placebo
intervention type: Drug
intervention name: ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)
description: The patient will then ongoing administration of ropivacaine 0.2% during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled (B Braun) of this solution, a flow rate of 9.53 ml / hour
arm group label: ropivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Olivier Helms, MD
role: Principal Investigator
facility: 
country: France
responsible party type: Sponsor
mesh term: Ropivacaine