<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/NCT04449289</url>
  </required_header>
  <id_info>
    <org_study_id>43/3.02.2020</org_study_id>
    <nct_id>NCT04449289</nct_id>
  </id_info>
  <brief_title>Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery</brief_title>
  <official_title>Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institutul Regional de Gastroenterologie &amp; Hepatologie Prof. dr. Octavian Fodor</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institutul Regional de Gastroenterologie &amp; Hepatologie Prof. dr. Octavian Fodor</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on&#xD;
      postoperative long and short term outcome in patients with pancreatic cancer undergoing&#xD;
      surgery.&#xD;
&#xD;
      As short term endpoints: postoperative complications and resumption of bowel function.&#xD;
&#xD;
      Long term endpoints include: 1 and 3 year recurrence and mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1- and 3-years recurrence rate after surgery</measure>
    <time_frame>3 years</time_frame>
    <description>Study participants will be contacted by study team via phone or e-mail</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1- and 3-years survival after surgery</measure>
    <time_frame>3 years</time_frame>
    <description>Study participants will be contacted by study team via phone or e-mail</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lidocaine and ropivacaine concentration</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate after surgery</measure>
    <time_frame>2 weeks</time_frame>
    <description>Resumption of bowel function, anastomotic leakage or hemorrhage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Intravenous lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epidural ropivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous lidocaine</intervention_name>
    <description>Intraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia</description>
    <arm_group_label>Intravenous lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epidural ropivacaine</intervention_name>
    <description>Intraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia</description>
    <arm_group_label>Epidural ropivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of pancreatic cancer&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) risk I - III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic pain&#xD;
&#xD;
          -  chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids&#xD;
&#xD;
          -  contraindications for any of the study medications&#xD;
&#xD;
          -  significant psychiatric disorders (major depression, bipolar disorders, schizophrenia,&#xD;
             etc.)&#xD;
&#xD;
          -  Convulsive disorders requiring medication during the last 2 years&#xD;
&#xD;
          -  liver cirrhosis/chronic kidney disease stage IV or V/chronic heart failure class III&#xD;
             or IV/ decompensated diabetes&#xD;
&#xD;
          -  Corticoid dependent asthma&#xD;
&#xD;
          -  Autoimmune disorders&#xD;
&#xD;
          -  Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere&#xD;
             with lidocaine's anti-arrhythmic effects&#xD;
&#xD;
          -  Refusal for study participation&#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>Daniela Ionescu, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Theodor Bot, PhD Student</last_name>
    <phone>0040765350176</phone>
    <email>theo_bot@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniela Ionescu, MD PhD</last_name>
    <phone>0744771209</phone>
    <email>dionescuati@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Regional Institute of Gastroenterology and Hepatology &quot;Prof. Dr. O. Fodor&quot;</name>
      <address>
        <city>Cluj-Napoca</city>
        <country>Romania</country>
      </address>
    </facility>
    <contact>
      <last_name>Theodor Bot</last_name>
      <phone>0040765350176</phone>
      <email>theo_bot@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institutul Regional de Gastroenterologie &amp; Hepatologie Prof. dr. Octavian Fodor</investigator_affiliation>
    <investigator_full_name>Theodor Bot</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <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/NCT04449289
org study id: 43/3.02.2020
nct id: NCT04449289
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on
      postoperative long and short term outcome in patients with pancreatic cancer undergoing
      surgery.

      As short term endpoints: postoperative complications and resumption of bowel function.

      Long term endpoints include: 1 and 3 year recurrence and mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 1- and 3-years recurrence rate after surgery
time frame: 3 years
description: Study participants will be contacted by study team via phone or e-mail
measure: 1- and 3-years survival after surgery
time frame: 3 years
description: Study participants will be contacted by study team via phone or e-mail
measure: Lidocaine and ropivacaine concentration
time frame: Intraoperatively
measure: Complication rate after surgery
time frame: 2 weeks
description: Resumption of bowel function, anastomotic leakage or hemorrhage
arm group label: Intravenous lidocaine
arm group type: Active Comparator
description: Patients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative
arm group label: Epidural ropivacaine
arm group type: Active Comparator
description: Patients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively
intervention type: Drug
intervention name: Intravenous lidocaine
description: Intraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia
arm group label: Intravenous lidocaine
intervention type: Drug
intervention name: Epidural ropivacaine
description: Intraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia
arm group label: Epidural ropivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Daniela Ionescu, MD PhD
role: Study Director
affiliation: Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor
last name: Theodor Bot, PhD Student
phone: 0040765350176
email: theo_bot@yahoo.com
last name: Daniela Ionescu, MD PhD
phone: 0744771209
email: dionescuati@yahoo.com
facility: 
contact: 
country: Romania
responsible party type: Principal Investigator
investigator affiliation: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
investigator full name: Theodor Bot
investigator title: PhD student
mesh term: Recurrence
mesh term: Lidocaine
mesh term: Ropivacaine