<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/NCT03228056</url>
  </required_header>
  <id_info>
    <org_study_id>PHZakopane</org_study_id>
    <nct_id>NCT03228056</nct_id>
  </id_info>
  <brief_title>Postoperative Pain After Single Port, Two Ports and Three Ports VATS Lobectomy</brief_title>
  <official_title>Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pulmonary Hospital Zakopane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pulmonary Hospital Zakopane</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>
      This single-center, prospective, randomized controlled trial was designed to assess and&#xD;
      compare the postoperative pain after VATS lobectomy performed though one, two and three&#xD;
      incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary&#xD;
      outcome measure is cumulative morphine consumption up to 72 hours after surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The best VATS technique for lobectomy has not been well defined yet. Most of the authors&#xD;
      describe the VATS approach to lobectomy via 2 to even 4 incisions. The final step in the&#xD;
      evolution of the technique is the use of a single-port approach. If conventional multiportal&#xD;
      VATS is superior to open thoracotomy by virtue of minimizing surgical access trauma, then&#xD;
      further reduction in such access trauma should yield even greater benefits. Therefore,&#xD;
      reducing the number of wounds from three or four to just one, should, in theory, lead to less&#xD;
      pain, paresthesia, and morbidity as well as faster recovery. However, critics of the&#xD;
      uniportal VATS approach may raise concerns about whether this most minimally invasive&#xD;
      surgical approach for lung surgery may compromise safety and treatment efficacy. In addition,&#xD;
      there's the concern about true invasiveness of the procedure. This prospective, randomized&#xD;
      controlled trial was designed to compare the postoperative pain after VATS lobectomy&#xD;
      performed through one, two and three incisions. The primary outcome measure is pain intensity&#xD;
      measured in VAS scale. The secondary outcome measures are cumulative morphine consumption up&#xD;
      to 72 hours after surgery in 4-hour intervals and dynamic spirometry (PEF, FEV1 and FVC)&#xD;
      measured daily at the bedside up to 72 hours after surgery. All patients will receive the&#xD;
      same regimen of postoperative analgesia based on thoracic epidural block, non-steroidal&#xD;
      anti-inflammatory drugs and rescue doses of morphine in PCA system. The side effects and&#xD;
      complications including atelectasis, pneumonia, atrial fibrillation, urine retention,&#xD;
      hypotension, respiratory depression and sedation will be analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain intensity</measure>
    <time_frame>up to 72 hours after the end of surgery</time_frame>
    <description>0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>opioid consumption</measure>
    <time_frame>up to 72 hours after the end of surgery</time_frame>
    <description>cumulative rescue morphine consumtion (PCA) in miligrams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of complications</measure>
    <time_frame>up to 72 hours after the end of surgery</time_frame>
    <description>frequency of postoperative complications (atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiatory depression, sedation)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>uniportal VATS lobectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>uniportal VATS lobectomy&#xD;
thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)&#xD;
ketoprofene 100 mg i.v every 12 hours&#xD;
paracetamol 1000 mg i.v every 8 hours&#xD;
rescue doses of morphine in PCA system (bolus dose 2 mg i.v)&#xD;
pain intensity measured in VAS scale</description>
  </arm_group>
  <arm_group>
    <arm_group_label>two-ports VATS lobectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>two-ports VATS lobectomy&#xD;
thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)&#xD;
ketoprofene 100 mg i.v every 12 hours&#xD;
paracetamol 1000 mg i.v every 8 hours&#xD;
rescue doses of morphine in PCA system (bolus dose 2 mg i.v)&#xD;
pain intensity measured in VAS scale</description>
  </arm_group>
  <arm_group>
    <arm_group_label>three-ports VATS lobectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>three-ports VATS lobectomy&#xD;
thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)&#xD;
ketoprofene 100 mg i.v every 12 hours&#xD;
paracetamol 1000 mg i.v every 8 hours&#xD;
rescue doses of morphine in PCA system (bolus dose 2 mg i.v)&#xD;
pain intensity measured in VAS scale</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>pain intensity measured in VAS scale</intervention_name>
    <description>Pain intensity in 0-100 mm VAS scale is measured every 4 hours on standard ruler beginning from the end of the surgery.</description>
    <arm_group_label>three-ports VATS lobectomy</arm_group_label>
    <arm_group_label>two-ports VATS lobectomy</arm_group_label>
    <arm_group_label>uniportal VATS lobectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. American Society of Anesthesiologists (ASA) physical status 1-3&#xD;
&#xD;
          2. undergo videothoracoscopic lung lobectomy&#xD;
&#xD;
          3. forced expiratory volume in 1 second (FEV1) &gt;1,5 l/min&#xD;
&#xD;
          4. no contraindications for epidural anesthesia&#xD;
&#xD;
          5. ability to comprehend principles of VAS pain examination method and to communicate in&#xD;
             accordance with them.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. prior to the study: contraindications for local anesthesia, ASA&gt;3, FEV1&lt;1,5 l/min,&#xD;
             conditions disabling the patient from comprehending the principles of VAS pain&#xD;
             examination, known allergy to used medications.&#xD;
&#xD;
          2. during the study: failure to place epidural catheter, decision to abandon lobar&#xD;
             resection (e.g. in case of neoplastic dissemination), intraoperative conversion to&#xD;
             thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics,&#xD;
             conditions disabling the patient from pain evaluation by means of VAS method (e.g.&#xD;
             postoperative delirium), necessity to administer other pharmaceuticals influencing&#xD;
             pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of&#xD;
             local anesthesia as a result of technical problems (e.g. damage or slippage of&#xD;
             catheter).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcin Zieliński, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pulmonary Hospital, Zakopane, Poland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sylweriusz Kosiński, PhD</last_name>
    <phone>602480289</phone>
    <email>kosa@mp.pl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pulmonary Hospital</name>
      <address>
        <city>Zakopane</city>
        <state>Malopolska</state>
        <zip>34-500</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylweriusz Kosiński</last_name>
      <phone>602480289</phone>
      <email>kosa@mp.pl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pulmonary Hospital</name>
      <address>
        <city>Zakopane</city>
        <zip>34-500</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylweriusz Kosiński</last_name>
      <phone>602480289</phone>
      <email>kosa@mp.pl</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>June 9, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>postoperative pain</keyword>
  <keyword>videothoracoscopic surgery</keyword>
  <keyword>thoracic epidural analgesia</keyword>
  <keyword>lung lobectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_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/NCT03228056
org study id: PHZakopane
nct id: NCT03228056
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This single-center, prospective, randomized controlled trial was designed to assess and
      compare the postoperative pain after VATS lobectomy performed though one, two and three
      incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary
      outcome measure is cumulative morphine consumption up to 72 hours after surgery
The best VATS technique for lobectomy has not been well defined yet. Most of the authors
      describe the VATS approach to lobectomy via 2 to even 4 incisions. The final step in the
      evolution of the technique is the use of a single-port approach. If conventional multiportal
      VATS is superior to open thoracotomy by virtue of minimizing surgical access trauma, then
      further reduction in such access trauma should yield even greater benefits. Therefore,
      reducing the number of wounds from three or four to just one, should, in theory, lead to less
      pain, paresthesia, and morbidity as well as faster recovery. However, critics of the
      uniportal VATS approach may raise concerns about whether this most minimally invasive
      surgical approach for lung surgery may compromise safety and treatment efficacy. In addition,
      there's the concern about true invasiveness of the procedure. This prospective, randomized
      controlled trial was designed to compare the postoperative pain after VATS lobectomy
      performed through one, two and three incisions. The primary outcome measure is pain intensity
      measured in VAS scale. The secondary outcome measures are cumulative morphine consumption up
      to 72 hours after surgery in 4-hour intervals and dynamic spirometry (PEF, FEV1 and FVC)
      measured daily at the bedside up to 72 hours after surgery. All patients will receive the
      same regimen of postoperative analgesia based on thoracic epidural block, non-steroidal
      anti-inflammatory drugs and rescue doses of morphine in PCA system. The side effects and
      complications including atelectasis, pneumonia, atrial fibrillation, urine retention,
      hypotension, respiratory depression and sedation will be analysed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: pain intensity
time frame: up to 72 hours after the end of surgery
description: 0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery
measure: opioid consumption
time frame: up to 72 hours after the end of surgery
description: cumulative rescue morphine consumtion (PCA) in miligrams
measure: rate of complications
time frame: up to 72 hours after the end of surgery
description: frequency of postoperative complications (atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiatory depression, sedation)
arm group label: uniportal VATS lobectomy
arm group type: Experimental
description: uniportal VATS lobectomy
thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
ketoprofene 100 mg i.v every 12 hours
paracetamol 1000 mg i.v every 8 hours
rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
pain intensity measured in VAS scale
arm group label: two-ports VATS lobectomy
arm group type: Active Comparator
description: two-ports VATS lobectomy
thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
ketoprofene 100 mg i.v every 12 hours
paracetamol 1000 mg i.v every 8 hours
rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
pain intensity measured in VAS scale
arm group label: three-ports VATS lobectomy
arm group type: Active Comparator
description: three-ports VATS lobectomy
thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
ketoprofene 100 mg i.v every 12 hours
paracetamol 1000 mg i.v every 8 hours
rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
pain intensity measured in VAS scale
intervention type: Diagnostic Test
intervention name: pain intensity measured in VAS scale
description: Pain intensity in 0-100 mm VAS scale is measured every 4 hours on standard ruler beginning from the end of the surgery.
arm group label: three-ports VATS lobectomy
arm group label: two-ports VATS lobectomy
arm group label: uniportal VATS lobectomy
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marcin Zieliński, PhD
role: Principal Investigator
affiliation: Pulmonary Hospital, Zakopane, Poland
last name: Sylweriusz Kosiński, PhD
phone: 602480289
email: kosa@mp.pl
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Poland
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No