<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/NCT02192879</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00042166</org_study_id>
    <nct_id>NCT02192879</nct_id>
  </id_info>
  <brief_title>TEA vs. PVB vs. PCA in Liver Resection Surgery</brief_title>
  <official_title>A Comparison of the Efficacy of Alternative Analgesia Modalities in Complex Hepatic Resection Surgery: Thoracic Epidural Analgesia Versus Continuous Paravertebral Block With Patient-Controlled Analgesia Versus Patient-Controlled Analgesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare the efficacy and safety of three alternative methods of analgesia&#xD;
      in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA),&#xD;
      2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3)&#xD;
      patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and PVB&#xD;
      may improve recovery and decrease postoperative pain scores in addition to other benefits&#xD;
      such earlier return of bowel function and shortened length of hospital stay, although some&#xD;
      practitioners have voiced concerns about the safety and efficacy of these techniques in&#xD;
      patients after liver resection who may develop postoperative coagulation abnormalities. The&#xD;
      investigators plan to enroll a total of 150 patients (adults &gt;/= 18 years of age who meet&#xD;
      study criteria) scheduled for complex liver resection surgery in this study, who will then be&#xD;
      randomized into 50 patients per arm of the study (3 total arms). Postoperative pain scores&#xD;
      will be collected in PACU and throughout the patient's hospital stay as well as routine blood&#xD;
      tests including complete blood count, coagulation labs (PT/INR, aPTT) and serum creatinine to&#xD;
      measure renal function. The study team will also collect additional data prospectively on all&#xD;
      patients enrolled in the study; these parameters will include age, sex, type of operation&#xD;
      performed, length of operation, volume of intraoperative blood loss, volume of intraoperative&#xD;
      fluid administration including blood products, daily postoperative intravenous fluid&#xD;
      administration, length of time to first feeding, day of epidural catheter removal, length of&#xD;
      hospital stay and incidence of major postoperative complications (surgical, respiratory,&#xD;
      cardiac, renal, etc.). Once primary and secondary data points are obtained, the data will&#xD;
      undergo rigorous statistical analysis using the appropriate statistical techniques to&#xD;
      determine the outcomes. The investigators propose that epidural and/or paravertebral&#xD;
      analgesia may improve recovery times and decrease hospital length of stay, which would be&#xD;
      beneficial for the patient as well as decrease hospital costs. In addition, if better&#xD;
      postoperative pain management scores can be achieved with epidural or paravertebral&#xD;
      analgesia, and no significant prolonged postoperative coagulopathy is associated with&#xD;
      patients undergoing major hepatic resection surgical procedures, these regional analgesia&#xD;
      strategies can be considered a safe option for pain management in this patient population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to recruit subjects&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Highest VAS Pain Score at Rest</measure>
    <time_frame>postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days</time_frame>
    <description>Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise</time_frame>
    <description>Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Recovery</measure>
    <time_frame>postoperatively until return of bowel function, up to 7 days</time_frame>
    <description>Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Postoperative Opioid Requirement</measure>
    <time_frame>postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 days</time_frame>
    <description>Cumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Major Postoperative Complication</measure>
    <time_frame>time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise</time_frame>
    <description>Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Highest VAS Pain Scores With Coughing</measure>
    <time_frame>postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days</time_frame>
    <description>Post-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Serious Adverse Events Associated With Regional Catheter Placement</measure>
    <time_frame>postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days</time_frame>
    <description>Serious adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Pain Management Strategies in Liver Resection Surgery</condition>
  <arm_group>
    <arm_group_label>Thoracic Epidural</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous Paravertebral Catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient-Controlled Analgesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>thoracic epidural</intervention_name>
    <description>Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
    <arm_group_label>Thoracic Epidural</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>continuous paravertebral catheter</intervention_name>
    <description>Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
    <arm_group_label>Continuous Paravertebral Catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Patient-Controlled Analgesia</intervention_name>
    <description>Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
    <arm_group_label>Patient-Controlled Analgesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;/= 18 years and &lt;/= 80 years&#xD;
&#xD;
          -  Scheduled for elective hepatic resection surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preexisting coagulopathy (INR &gt;1.5)&#xD;
&#xD;
          -  Spinal stenosis&#xD;
&#xD;
          -  Local infection in area where catheter will be inserted&#xD;
&#xD;
          -  Severe cardiovascular disease (NYHA Class III/IV)&#xD;
&#xD;
          -  Severe pulmonary disease (FEV1 &lt;50% of predicted value)&#xD;
&#xD;
          -  Allergy or sensitivity to narcotics or local anesthetics&#xD;
&#xD;
          -  BMI &gt;45&#xD;
&#xD;
          -  Inability to give informed consent&#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>Elizabeth B Malinzak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <results_first_submitted>July 25, 2016</results_first_submitted>
  <results_first_submitted_qc>July 25, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 12, 2016</results_first_posted>
  <last_update_submitted>September 13, 2016</last_update_submitted>
  <last_update_submitted_qc>September 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>thoracic epidural</keyword>
  <keyword>continuous paravertebral catheter</keyword>
  <keyword>PCA</keyword>
  <keyword>liver resection</keyword>
  <keyword>pain management</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Thoracic Epidural</title>
          <description>thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
        </group>
        <group group_id="P2">
          <title>Continuous Paravertebral Catheter</title>
          <description>continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
        </group>
        <group group_id="P3">
          <title>Patient-Controlled Analgesia</title>
          <description>Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Thoracic Epidural</title>
          <description>thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
        </group>
        <group group_id="B2">
          <title>Continuous Paravertebral Catheter</title>
          <description>continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
        </group>
        <group group_id="B3">
          <title>Patient-Controlled Analgesia</title>
          <description>Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Highest VAS Pain Score at Rest</title>
        <description>Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).</description>
        <time_frame>postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Thoracic Epidural</title>
            <description>thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
          </group>
          <group group_id="O2">
            <title>Continuous Paravertebral Catheter</title>
            <description>continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
          </group>
          <group group_id="O3">
            <title>Patient-Controlled Analgesia</title>
            <description>Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
          </group>
        </group_list>
        <measure>
          <title>Highest VAS Pain Score at Rest</title>
          <description>Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.67" spread="2.08"/>
                    <measurement group_id="O2" value="7.0" spread="2.94"/>
                    <measurement group_id="O3" value="7.67" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <description>Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.</description>
        <time_frame>time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Thoracic Epidural</title>
            <description>thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
          </group>
          <group group_id="O2">
            <title>Continuous Paravertebral Catheter</title>
            <description>continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
          </group>
          <group group_id="O3">
            <title>Patient-Controlled Analgesia</title>
            <description>Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.33" spread="4.93"/>
                    <measurement group_id="O2" value="6.25" spread="2.5"/>
                    <measurement group_id="O3" value="7.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gastrointestinal Recovery</title>
        <description>Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.</description>
        <time_frame>postoperatively until return of bowel function, up to 7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Thoracic Epidural</title>
            <description>thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
          </group>
          <group group_id="O2">
            <title>Continuous Paravertebral Catheter</title>
            <description>continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
          </group>
          <group group_id="O3">
            <title>Patient-Controlled Analgesia</title>
            <description>Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
          </group>
        </group_list>
        <measure>
          <title>Gastrointestinal Recovery</title>
          <description>Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="0.58"/>
                    <measurement group_id="O2" value="4.25" spread="2.63"/>
                    <measurement group_id="O3" value="5.33" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Postoperative Opioid Requirement</title>
        <description>Cumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.</description>
        <time_frame>postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Thoracic Epidural</title>
            <description>thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
          </group>
          <group group_id="O2">
            <title>Continuous Paravertebral Catheter</title>
            <description>continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
          </group>
          <group group_id="O3">
            <title>Patient-Controlled Analgesia</title>
            <description>Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Postoperative Opioid Requirement</title>
          <description>Cumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="388.33" spread="430.71"/>
                    <measurement group_id="O2" value="224.6" spread="236.5"/>
                    <measurement group_id="O3" value="176.20" spread="40.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Major Postoperative Complication</title>
        <description>Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.</description>
        <time_frame>time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Thoracic Epidural</title>
            <description>thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
          </group>
          <group group_id="O2">
            <title>Continuous Paravertebral Catheter</title>
            <description>continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
          </group>
          <group group_id="O3">
            <title>Patient-Controlled Analgesia</title>
            <description>Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Major Postoperative Complication</title>
          <description>Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.</description>
          <units>complications</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Highest VAS Pain Scores With Coughing</title>
        <description>Post-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).</description>
        <time_frame>postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Thoracic Epidural</title>
            <description>thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
          </group>
          <group group_id="O2">
            <title>Continuous Paravertebral Catheter</title>
            <description>continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
          </group>
          <group group_id="O3">
            <title>Patient-Controlled Analgesia</title>
            <description>Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
          </group>
        </group_list>
        <measure>
          <title>Highest VAS Pain Scores With Coughing</title>
          <description>Post-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.33" spread="2.52"/>
                    <measurement group_id="O2" value="8.0" spread="2.45"/>
                    <measurement group_id="O3" value="8.33" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Serious Adverse Events Associated With Regional Catheter Placement</title>
        <description>Serious adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored</description>
        <time_frame>postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days</time_frame>
        <population>only patients who had a catheter</population>
        <group_list>
          <group group_id="O1">
            <title>Thoracic Epidural</title>
            <description>thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
          </group>
          <group group_id="O2">
            <title>Continuous Paravertebral Catheter</title>
            <description>continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
          </group>
          <group group_id="O3">
            <title>Patient-Controlled Analgesia</title>
            <description>Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
          </group>
        </group_list>
        <measure>
          <title>Serious Adverse Events Associated With Regional Catheter Placement</title>
          <description>Serious adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored</description>
          <population>only patients who had a catheter</population>
          <units>serious adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Thoracic Epidural</title>
          <description>thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).</description>
        </group>
        <group group_id="E2">
          <title>Continuous Paravertebral Catheter</title>
          <description>continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.</description>
        </group>
        <group group_id="E3">
          <title>Patient-Controlled Analgesia</title>
          <description>Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>blurred vision</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>bile leak</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>diaphragm leak</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Unable to recruit adequate number of participants, and decision was made to terminate the study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Elizabeth Malinzak, MD</name_or_title>
      <organization>Duke University Medical Center</organization>
      <phone>919-681-9660</phone>
      <email>elizabeth.malinzak@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02192879
org study id: Pro00042166
nct id: NCT02192879
lead sponsor: 
has dmc: Yes
This study aims to compare the efficacy and safety of three alternative methods of analgesia
      in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA),
      2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3)
      patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and PVB
      may improve recovery and decrease postoperative pain scores in addition to other benefits
      such earlier return of bowel function and shortened length of hospital stay, although some
      practitioners have voiced concerns about the safety and efficacy of these techniques in
      patients after liver resection who may develop postoperative coagulation abnormalities. The
      investigators plan to enroll a total of 150 patients (adults >/= 18 years of age who meet
      study criteria) scheduled for complex liver resection surgery in this study, who will then be
      randomized into 50 patients per arm of the study (3 total arms). Postoperative pain scores
      will be collected in PACU and throughout the patient's hospital stay as well as routine blood
      tests including complete blood count, coagulation labs (PT/INR, aPTT) and serum creatinine to
      measure renal function. The study team will also collect additional data prospectively on all
      patients enrolled in the study; these parameters will include age, sex, type of operation
      performed, length of operation, volume of intraoperative blood loss, volume of intraoperative
      fluid administration including blood products, daily postoperative intravenous fluid
      administration, length of time to first feeding, day of epidural catheter removal, length of
      hospital stay and incidence of major postoperative complications (surgical, respiratory,
      cardiac, renal, etc.). Once primary and secondary data points are obtained, the data will
      undergo rigorous statistical analysis using the appropriate statistical techniques to
      determine the outcomes. The investigators propose that epidural and/or paravertebral
      analgesia may improve recovery times and decrease hospital length of stay, which would be
      beneficial for the patient as well as decrease hospital costs. In addition, if better
      postoperative pain management scores can be achieved with epidural or paravertebral
      analgesia, and no significant prolonged postoperative coagulopathy is associated with
      patients undergoing major hepatic resection surgical procedures, these regional analgesia
      strategies can be considered a safe option for pain management in this patient population.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Highest VAS Pain Score at Rest
time frame: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days
description: Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).
measure: Hospital Length of Stay
time frame: time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise
description: Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.
measure: Gastrointestinal Recovery
time frame: postoperatively until return of bowel function, up to 7 days
description: Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.
measure: Cumulative Postoperative Opioid Requirement
time frame: postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 days
description: Cumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.
measure: Incidence of Major Postoperative Complication
time frame: time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise
description: Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.
measure: Highest VAS Pain Scores With Coughing
time frame: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days
description: Post-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).
measure: Serious Adverse Events Associated With Regional Catheter Placement
time frame: postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days
description: Serious adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored
arm group label: Thoracic Epidural
arm group type: Active Comparator
arm group label: Continuous Paravertebral Catheter
arm group type: Active Comparator
arm group label: Patient-Controlled Analgesia
arm group type: Active Comparator
intervention type: Device
intervention name: thoracic epidural
description: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
arm group label: Thoracic Epidural
intervention type: Device
intervention name: continuous paravertebral catheter
description: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
arm group label: Continuous Paravertebral Catheter
intervention type: Drug
intervention name: Patient-Controlled Analgesia
description: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
arm group label: Patient-Controlled Analgesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Elizabeth B Malinzak, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Unable to recruit adequate number of participants, and decision was made to terminate the study.
point of contact: 