<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/NCT01703351</url>
  </required_header>
  <id_info>
    <org_study_id>4-2012-0470</org_study_id>
    <nct_id>NCT01703351</nct_id>
  </id_info>
  <brief_title>Prospective Randomized Trial Comparing the Effectiveness of Continuous Paravertebral Infusion of Local Anesthetics Versus Intravenous Patient-controlled Analgesia on Acute and Chronic Neuropathic Pain After VATS Lobectomy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy&#xD;
      and it has reduced the operative morbidities and mortalities. However, thoracoscopic&#xD;
      lobectomy also results in operative acute pain and the incidence of chronic pain after&#xD;
      thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar,&#xD;
      torque at trocar and working window by operator, and compression of intercostal nerves have&#xD;
      been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous&#xD;
      patient-controlled analgesia (IV PCA) that usually have used to control the operative pain,&#xD;
      sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic&#xD;
      delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the&#xD;
      effective dose of analgesics could not deliver to patients. In contrast to IV PCA, continuous&#xD;
      paravertebral infusion of local anesthetics thorough catheter below the parietal pleura might&#xD;
      reduce the side effects of IV PCA and control the operative pain effectively. In this study,&#xD;
      we investigate the effectiveness of continuous paravertebral infusion of local anesthetics&#xD;
      thorough catheter below the parietal pleura for 60 hours after operation competed to IV PCA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 4, 2012</start_date>
  <completion_date type="Actual">November 6, 2015</completion_date>
  <primary_completion_date type="Actual">November 6, 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1. Acute pain</measure>
    <time_frame>Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>2. Quality of life</measure>
    <time_frame>measured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>3. Neuropathic pain</measure>
    <time_frame>VAS score and dose of analgesics in 4, 12 weeks after operation</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Lung Neoplasms</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Drug: 0.5% ropivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl 500mcg + acupan 160mg + nasea 0.6mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.5% ropivacaine</intervention_name>
    <description>(n=48); continuous paravertebral infusion of local anesthetics (0.5% ropivacaine, 5cc/hr for 60 hours after operation) thorough catheter below the parietal pleura using On-Q® system(I-flow corp, Lake Forest, CA, USA)</description>
    <arm_group_label>Drug: 0.5% ropivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl 500mcg + acupan 160mg + nasea 0.6mg</intervention_name>
    <description>(n=48); IV PCA (Fentanyl 500mcg + acupan 160mg + nasea 0.6mg, 5cc/hr for 60 hours after operation, 0.5cc bolus if patients feel breakthrough pain)</description>
    <arm_group_label>Fentanyl 500mcg + acupan 160mg + nasea 0.6mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age; 18≥, &lt;75&#xD;
&#xD;
          -  Thoracoscopic lobectomy due to lung cancer or suspected lung cancer&#xD;
&#xD;
          -  Tolerable cardiopulmonary and other systemic function tolerable to lobectomy&#xD;
&#xD;
          -  Karnofsky performance status ≥ 80&#xD;
&#xD;
          -  Agree with study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerable to one-lung ventilation&#xD;
&#xD;
          -  Bleeding risk due to Aspirin, coumadin and other drugs&#xD;
&#xD;
          -  Past or current history of depression or other psychiatric disease&#xD;
&#xD;
          -  Pain persisted before operation due to lung lesion&#xD;
&#xD;
          -  History of rib fracture, trauma or lung surgery at the same side of operation&#xD;
&#xD;
          -  Severe pleural adhesion or empyema&#xD;
&#xD;
          -  Open thoracotomy conversion&#xD;
&#xD;
          -  Reoperation due to postoperative bleeding or others&#xD;
&#xD;
          -  Postoperative complications that need ICU care&#xD;
&#xD;
          -  Chemical pleurodesis more than two times after operation&#xD;
&#xD;
          -  Do not agree with study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pain control, VATS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</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/NCT01703351
org study id: 4-2012-0470
nct id: NCT01703351
lead sponsor: 
has dmc: No
Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy
      and it has reduced the operative morbidities and mortalities. However, thoracoscopic
      lobectomy also results in operative acute pain and the incidence of chronic pain after
      thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar,
      torque at trocar and working window by operator, and compression of intercostal nerves have
      been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous
      patient-controlled analgesia (IV PCA) that usually have used to control the operative pain,
      sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic
      delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the
      effective dose of analgesics could not deliver to patients. In contrast to IV PCA, continuous
      paravertebral infusion of local anesthetics thorough catheter below the parietal pleura might
      reduce the side effects of IV PCA and control the operative pain effectively. In this study,
      we investigate the effectiveness of continuous paravertebral infusion of local anesthetics
      thorough catheter below the parietal pleura for 60 hours after operation competed to IV PCA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 1. Acute pain
time frame: Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)
measure: 2. Quality of life
time frame: measured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation
measure: 3. Neuropathic pain
time frame: VAS score and dose of analgesics in 4, 12 weeks after operation
arm group label: Drug: 0.5% ropivacaine
arm group type: Experimental
arm group label: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg
arm group type: Active Comparator
intervention type: Drug
intervention name: 0.5% ropivacaine
description: (n=48); continuous paravertebral infusion of local anesthetics (0.5% ropivacaine, 5cc/hr for 60 hours after operation) thorough catheter below the parietal pleura using On-Q® system(I-flow corp, Lake Forest, CA, USA)
arm group label: Drug: 0.5% ropivacaine
intervention type: Drug
intervention name: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg
description: (n=48); IV PCA (Fentanyl 500mcg + acupan 160mg + nasea 0.6mg, 5cc/hr for 60 hours after operation, 0.5cc bolus if patients feel breakthrough pain)
arm group label: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 78 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Fentanyl
mesh term: Ropivacaine