<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/NCT01718717</url>
  </required_header>
  <id_info>
    <org_study_id>TEA and AF</org_study_id>
    <nct_id>NCT01718717</nct_id>
  </id_info>
  <brief_title>Effect of Thoracic Epidural Analgesia for Thoracotomy on the Occurrence of AF</brief_title>
  <official_title>Effect of Thoracic Epidural Analgesia for Thoracic Surgery on Arrhythiogenesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Larissa University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Larissa University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thoracic epidural anesthesia and analgesia for patients undergoing lung resection can reduce&#xD;
      the occurrence of AF if it is continued for six postoperative days instead of just three.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      THEA is considered a very effective technique of providing intra and post-operative analgesia&#xD;
      for thoracic surgical procedure and it seems that can also be effective in reducing the&#xD;
      incidence of postoperative AF in patients undergoing lung resection. Nevertheless the timing&#xD;
      of stopping the epidural analgesia and its further substitution with other therapies, remains&#xD;
      unclear.&#xD;
&#xD;
      In this study patients who are scheduled for lung resection surgery will undergo the surgery&#xD;
      under combined general anesthesia with volatile anesthetics and thoracic epidural anesthesia.&#xD;
&#xD;
      Immediately after surgery the patients will be divided into two groups:&#xD;
&#xD;
        -  those who will receive thoracic epidural analgesia for 6 days&#xD;
&#xD;
        -  those who will receive thoracic epidural analgesia for 3 days and will then switch to&#xD;
           intravenous morphine for another 3 days&#xD;
&#xD;
      All the patients will be monitored daily for arrythmias&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of AF</measure>
    <time_frame>6 postoperative days</time_frame>
    <description>Every day, for the first 6 postoperative days, the investigators will record an ECG of the patient, and look after for any presence of AF</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of analgesia</measure>
    <time_frame>6 postoperative days</time_frame>
    <description>The investigators will record the quality of analgesia, as it can be measured with VAS, for the 6 first postoperative days for all patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Posterolateral Thoracotomy</condition>
  <condition>Lung Resection</condition>
  <condition>Thoracic Epidural Analgesia</condition>
  <condition>Sympathetic Outflow</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>6 days TEA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Postoperative analgesia for the first six postoperative days with TEA and daily monitoring for arrhythmia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 days TEA and 3 days intravenous morphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Postoperative analgesia for the first three postoperative days with TEA followed for the next three days with intravenous morphine, and daily monitoring for arrhythmia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thoracic Epidural Analgesia (TEA)</intervention_name>
    <arm_group_label>6 days TEA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TEA followed by Intravenous morphine</intervention_name>
    <arm_group_label>3 days TEA and 3 days intravenous morphine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lung resection&#xD;
&#xD;
          -  pneumonectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  AF (present or in the past&#xD;
&#xD;
          -  contraindications for epidural catheter placement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Metaxia Bareka, Medicine</last_name>
    <role>Principal Investigator</role>
    <affiliation>Larissa University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marina Simaioforidou, Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Larissa University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Metaxia Bareka, Medicine</last_name>
    <phone>00306947845083</phone>
    <phone_ext>1370</phone_ext>
    <email>barekametaxia@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marina Simaioforidou, Medicine</last_name>
    <phone>00306972202573</phone>
    <phone_ext>1370</phone_ext>
    <email>msimaiof@otenet.gr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Larissa University Hospital</name>
      <address>
        <city>Larissa</city>
        <state>Thessally</state>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.</citation>
    <PMID>11118174</PMID>
  </reference>
  <reference>
    <citation>O'Higgins F, Tuckey JP. Thoracic epidural anaesthesia and analgesia: United Kingdom practice. Acta Anaesthesiol Scand. 2000 Oct;44(9):1087-92. doi: 10.1034/j.1399-6576.2000.440909.x.</citation>
    <PMID>11028728</PMID>
  </reference>
  <reference>
    <citation>Mendola C, Ferrante D, Oldani E, Cammarota G, Cecci G, Vaschetto R, Della Corte F. Thoracic epidural analgesia in post-thoracotomy patients: comparison of three different concentrations of levobupivacaine and sufentanil. Br J Anaesth. 2009 Mar;102(3):418-23. doi: 10.1093/bja/aep004. Epub 2009 Feb 3.</citation>
    <PMID>19189982</PMID>
  </reference>
  <reference>
    <citation>De Cosmo G, Aceto P, Gualtieri E, Congedo E. Analgesia in thoracic surgery: review. Minerva Anestesiol. 2009 Jun;75(6):393-400. Epub 2008 Oct 27.</citation>
    <PMID>18953284</PMID>
  </reference>
  <reference>
    <citation>Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.</citation>
    <PMID>19307137</PMID>
  </reference>
  <reference>
    <citation>Scarci M, Joshi A, Attia R. In patients undergoing thoracic surgery is paravertebral block as effective as epidural analgesia for pain management? Interact Cardiovasc Thorac Surg. 2010 Jan;10(1):92-6. doi: 10.1510/icvts.2009.221127. Epub 2009 Oct 23.</citation>
    <PMID>19854794</PMID>
  </reference>
  <reference>
    <citation>Shrivastava V, Nyawo B, Dunning J, Morritt G. Is there a role for prophylaxis against atrial fibrillation for patients undergoing lung surgery? Interact Cardiovasc Thorac Surg. 2004 Dec;3(4):656-62. doi: 10.1016/j.icvts.2004.08.002.</citation>
    <PMID>17670334</PMID>
  </reference>
  <reference>
    <citation>Oka T, Ozawa Y, Ohkubo Y. Thoracic epidural bupivacaine attenuates supraventricular tachyarrhythmias after pulmonary resection. Anesth Analg. 2001 Aug;93(2):253-9, 1st contents page. doi: 10.1097/00000539-200108000-00003.</citation>
    <PMID>11473839</PMID>
  </reference>
  <reference>
    <citation>Simeoforidou M, Vretzakis G, Bareka M, Chantzi E, Flossos A, Giannoukas A, Tsilimingas N. Thoracic epidural analgesia with levobupivacaine for 6 postoperative days attenuates sympathetic activation after thoracic surgery. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):817-23. doi: 10.1053/j.jvca.2010.08.003. Epub 2010 Oct 13.</citation>
    <PMID>20947382</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Larissa University Hospital</investigator_affiliation>
    <investigator_full_name>Metaxia Bareka</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>Thoracotomy</keyword>
  <keyword>Thoracic epidural analgesia</keyword>
  <keyword>Arrythmiogenesis</keyword>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Sympathetic outflow</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</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/NCT01718717
org study id: TEA and AF
nct id: NCT01718717
lead sponsor: 
has dmc: No
Thoracic epidural anesthesia and analgesia for patients undergoing lung resection can reduce
      the occurrence of AF if it is continued for six postoperative days instead of just three.
THEA is considered a very effective technique of providing intra and post-operative analgesia
      for thoracic surgical procedure and it seems that can also be effective in reducing the
      incidence of postoperative AF in patients undergoing lung resection. Nevertheless the timing
      of stopping the epidural analgesia and its further substitution with other therapies, remains
      unclear.

      In this study patients who are scheduled for lung resection surgery will undergo the surgery
      under combined general anesthesia with volatile anesthetics and thoracic epidural anesthesia.

      Immediately after surgery the patients will be divided into two groups:

        -  those who will receive thoracic epidural analgesia for 6 days

        -  those who will receive thoracic epidural analgesia for 3 days and will then switch to
           intravenous morphine for another 3 days

      All the patients will be monitored daily for arrythmias
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Occurrence of AF
time frame: 6 postoperative days
description: Every day, for the first 6 postoperative days, the investigators will record an ECG of the patient, and look after for any presence of AF
measure: Quality of analgesia
time frame: 6 postoperative days
description: The investigators will record the quality of analgesia, as it can be measured with VAS, for the 6 first postoperative days for all patients
arm group label: 6 days TEA
arm group type: Active Comparator
description: Postoperative analgesia for the first six postoperative days with TEA and daily monitoring for arrhythmia
arm group label: 3 days TEA and 3 days intravenous morphine
arm group type: Active Comparator
description: Postoperative analgesia for the first three postoperative days with TEA followed for the next three days with intravenous morphine, and daily monitoring for arrhythmia
intervention type: Other
intervention name: Thoracic Epidural Analgesia (TEA)
arm group label: 6 days TEA
intervention type: Other
intervention name: TEA followed by Intravenous morphine
arm group label: 3 days TEA and 3 days intravenous morphine
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Metaxia Bareka, Medicine
role: Principal Investigator
affiliation: Larissa University Hospital
last name: Marina Simaioforidou, Medicine
role: Study Chair
affiliation: Larissa University Hospital
last name: Metaxia Bareka, Medicine
phone: 00306947845083
phone ext: 1370
email: barekametaxia@hotmail.com
last name: Marina Simaioforidou, Medicine
phone: 00306972202573
phone ext: 1370
email: msimaiof@otenet.gr
facility: 
country: Greece
citation: Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
PMID: 11118174
citation: O'Higgins F, Tuckey JP. Thoracic epidural anaesthesia and analgesia: United Kingdom practice. Acta Anaesthesiol Scand. 2000 Oct;44(9):1087-92. doi: 10.1034/j.1399-6576.2000.440909.x.
PMID: 11028728
citation: Mendola C, Ferrante D, Oldani E, Cammarota G, Cecci G, Vaschetto R, Della Corte F. Thoracic epidural analgesia in post-thoracotomy patients: comparison of three different concentrations of levobupivacaine and sufentanil. Br J Anaesth. 2009 Mar;102(3):418-23. doi: 10.1093/bja/aep004. Epub 2009 Feb 3.
PMID: 19189982
citation: De Cosmo G, Aceto P, Gualtieri E, Congedo E. Analgesia in thoracic surgery: review. Minerva Anestesiol. 2009 Jun;75(6):393-400. Epub 2008 Oct 27.
PMID: 18953284
citation: Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
PMID: 19307137
citation: Scarci M, Joshi A, Attia R. In patients undergoing thoracic surgery is paravertebral block as effective as epidural analgesia for pain management? Interact Cardiovasc Thorac Surg. 2010 Jan;10(1):92-6. doi: 10.1510/icvts.2009.221127. Epub 2009 Oct 23.
PMID: 19854794
citation: Shrivastava V, Nyawo B, Dunning J, Morritt G. Is there a role for prophylaxis against atrial fibrillation for patients undergoing lung surgery? Interact Cardiovasc Thorac Surg. 2004 Dec;3(4):656-62. doi: 10.1016/j.icvts.2004.08.002.
PMID: 17670334
citation: Oka T, Ozawa Y, Ohkubo Y. Thoracic epidural bupivacaine attenuates supraventricular tachyarrhythmias after pulmonary resection. Anesth Analg. 2001 Aug;93(2):253-9, 1st contents page. doi: 10.1097/00000539-200108000-00003.
PMID: 11473839
citation: Simeoforidou M, Vretzakis G, Bareka M, Chantzi E, Flossos A, Giannoukas A, Tsilimingas N. Thoracic epidural analgesia with levobupivacaine for 6 postoperative days attenuates sympathetic activation after thoracic surgery. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):817-23. doi: 10.1053/j.jvca.2010.08.003. Epub 2010 Oct 13.
PMID: 20947382
responsible party type: Principal Investigator
investigator affiliation: Larissa University Hospital
investigator full name: Metaxia Bareka
investigator title: Anesthesiologist
mesh term: Atrial Fibrillation
mesh term: Morphine