<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/NCT03307174</url>
  </required_header>
  <id_info>
    <org_study_id>15-18354</org_study_id>
    <nct_id>NCT03307174</nct_id>
  </id_info>
  <brief_title>Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.</brief_title>
  <official_title>A Prospective, Randomized Analysis of Epidural Anesthesia Using Programmed Intermittent Epidural Boluses Versus Continuous Epidural Infusion in Patients Undergoing Abdominal Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior&#xD;
      studies in labor epidurals have demonstrated that a programmed intermittent bolus application&#xD;
      of local anesthesia can improve pain control by reducing the amount of local anesthetic&#xD;
      required as well as improve patient satisfaction when compared to continuous epidural&#xD;
      infusions. The effects of programmed intermittent bolus of epidural local anesthetics&#xD;
      compared to continuous epidural infusions in a surgical setting have yet to be elucidated.&#xD;
      Our goal is to evaluate the use of programmed intermittent bolus compared to continuous&#xD;
      epidural infusion in a surgical patient population. We plan to enroll patients already&#xD;
      undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology,&#xD;
      urological where epidural anesthesia can be employed. The primary endpoints of the study will&#xD;
      be the total local anesthetic consumption and total opioid consumption as surrogate markers&#xD;
      for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional&#xD;
      measurements, patient satisfaction, and incidence of hypotension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      See brief summary&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 14, 2016</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>Phase 4</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>Total Local Anesthetic Utilized in First 24 Hours</measure>
    <time_frame>In first 24 hours</time_frame>
    <description>Total local anesthetic consumed while epidural in place, recorded on infusion pump</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Opioid Consumed</measure>
    <time_frame>While epidural in place (up to 72 hours post operatively)</time_frame>
    <description>Total opioid consumed (intravenous or po) while epidural in place</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Score</measure>
    <time_frame>While epidural in place (up to 72 hours postoperatively)</time_frame>
    <description>Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory.&#xD;
Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Pain Severity</measure>
    <time_frame>While epidural in place (up to 72 hours postoperatively)</time_frame>
    <description>Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Hypotension</measure>
    <time_frame>While epidural in place (24 hours postoperatively)</time_frame>
    <description>Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worst Reported 24 Hour Pain</measure>
    <time_frame>While epidural in place (up to 72 hours postoperatively)</time_frame>
    <description>Minimum is 0, maximum is 10. 10 indicates highest pain severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Pain Interference</measure>
    <time_frame>While epidural in place (up to 72 hours postoperatively)</time_frame>
    <description>Minimum is 0, maximum is 10. 10 indicates highest pain interference.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Pain, Acute</condition>
  <arm_group>
    <arm_group_label>Continuous epidural infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Programmed intermittent epidural bolus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <arm_group_label>Continuous epidural infusion</arm_group_label>
    <arm_group_label>Programmed intermittent epidural bolus</arm_group_label>
    <other_name>0.0625% bupivacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <arm_group_label>Continuous epidural infusion</arm_group_label>
    <arm_group_label>Programmed intermittent epidural bolus</arm_group_label>
    <other_name>2mcg/ml fentanyl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesia physical classification I - III, scheduled for surgery&#xD;
             with anticipated an epidural anesthesia (including but not limited to colorectal,&#xD;
             surgical oncology, urology, gynecology) as part of their perioperative treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age younger than 18 years of age, non-English speaking, contraindication for neuraxial&#xD;
             anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to&#xD;
             local anesthetic), preexisting neurologic deficits, inability to consent due to&#xD;
             cognitive dysfunction, patients with pain numeric rating score &gt; 5 each day for&#xD;
             greater than 3 months, daily opioid consumption &gt; 100 oral morphine equivalents for 14&#xD;
             consecutive days prior to surgery, patient refusal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Behrends, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <results_first_submitted>April 8, 2020</results_first_submitted>
  <results_first_submitted_qc>April 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2020</results_first_posted>
  <last_update_submitted>April 29, 2020</last_update_submitted>
  <last_update_submitted_qc>April 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03307174/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were enrolled between December 2016 to December 2018</recruitment_details>
      <pre_assignment_details>Patients were not randomized to study groups if epidurals were not able to be successfully placed.&#xD;
2 subjects in the CEI group were no included in the analysis due to missing data&#xD;
1 subject in the PIEB group was not included in the analysis due to missing data</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Continuous Epidural Infusion</title>
          <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
        </group>
        <group group_id="P2">
          <title>Programmed Intermittent Epidural Bolus</title>
          <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Unplanned ICU Administrion</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Aborted Surgery</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Hypotension</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Nonfunctional epidural</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Planned epidural removal</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Intrathecal catheter placement</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Continuous Epidural Infusion</title>
          <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
        </group>
        <group group_id="B2">
          <title>Programmed Intermittent Epidural Bolus</title>
          <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
        </group>
        <group group_id="B3">
          <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="60"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="120"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" spread="14"/>
                    <measurement group_id="B2" value="55" spread="16"/>
                    <measurement group_id="B3" value="57" spread="15"/>
                  </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="42"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latinx</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Home Medication Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Acetaminophen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NSAIDS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gabapentinoids</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TCA/SNRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Daily opioid consumption</title>
          <units>MME</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain Severity</title>
          <description>Minimum of 0, maximum of 10. 10 indicates higher severity of pain.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>Current Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worst Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="0" upper_limit="6"/>
                    <measurement group_id="B2" value="4" lower_limit="0" upper_limit="7"/>
                    <measurement group_id="B3" value="3" lower_limit="0" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Least Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="B2" value="2" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="B3" value="1" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average Pain Interference</title>
          <description>Minimum of 0, maximum of 10. 10 indicates more severe interference of activities due to pain.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B2" value="2" lower_limit="0" upper_limit="6"/>
                    <measurement group_id="B3" value="1" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>World Health Organization Disability Assessment Schedule 2.0</title>
          <description>Minimum of 0, maximum of 100. Score of 100 indicates fully disabled</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12" lower_limit="4" upper_limit="30"/>
                    <measurement group_id="B2" value="19" lower_limit="12" upper_limit="32"/>
                    <measurement group_id="B3" value="17" lower_limit="8" upper_limit="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HADS Anxiety Score</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Depression HADS Score</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length of Epidural Therapy</title>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B2" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B3" value="2" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Upper GI (gastric, small intestine)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lower GI (colorectal)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatobiliary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gynecologic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intraoperative Opioids</title>
          <units>MME</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38" lower_limit="18" upper_limit="60"/>
                    <measurement group_id="B2" value="44" lower_limit="16" upper_limit="61"/>
                    <measurement group_id="B3" value="39" lower_limit="16" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Local Anesthetic Utilized in First 24 Hours</title>
        <description>Total local anesthetic consumed while epidural in place, recorded on infusion pump</description>
        <time_frame>In first 24 hours</time_frame>
        <population>Note that 2 patients in the CEI group and 1 patient in the PIEB group was not included in the analysis due to missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Continuous Epidural Infusion</title>
            <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
          <group group_id="O2">
            <title>Programmed Intermittent Epidural Bolus</title>
            <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
        </group_list>
        <measure>
          <title>Total Local Anesthetic Utilized in First 24 Hours</title>
          <description>Total local anesthetic consumed while epidural in place, recorded on infusion pump</description>
          <population>Note that 2 patients in the CEI group and 1 patient in the PIEB group was not included in the analysis due to missing data.</population>
          <units>mg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126" lower_limit="120" upper_limit="134"/>
                    <measurement group_id="O2" value="123" lower_limit="115" upper_limit="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.74</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Opioid Consumed</title>
        <description>Total opioid consumed (intravenous or po) while epidural in place</description>
        <time_frame>While epidural in place (up to 72 hours post operatively)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Epidural Infusion</title>
            <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
          <group group_id="O2">
            <title>Programmed Intermittent Epidural Bolus</title>
            <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
        </group_list>
        <measure>
          <title>Total Opioid Consumed</title>
          <description>Total opioid consumed (intravenous or po) while epidural in place</description>
          <units>MME</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="0" upper_limit="28"/>
                    <measurement group_id="O2" value="16" lower_limit="0" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 - 48 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="25"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 - 72 hrs postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction Score</title>
        <description>Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory.&#xD;
Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.</description>
        <time_frame>While epidural in place (up to 72 hours postoperatively)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Epidural Infusion</title>
            <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
          <group group_id="O2">
            <title>Programmed Intermittent Epidural Bolus</title>
            <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction Score</title>
          <description>Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory.&#xD;
Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="8" upper_limit="10"/>
                    <measurement group_id="O2" value="8" lower_limit="6.5" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 - 48 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="7" upper_limit="10"/>
                    <measurement group_id="O2" value="9" lower_limit="7.3" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 - 72 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="7" upper_limit="10"/>
                    <measurement group_id="O2" value="9" lower_limit="8" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Pain Severity</title>
        <description>Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.</description>
        <time_frame>While epidural in place (up to 72 hours postoperatively)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Epidural Infusion</title>
            <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
          <group group_id="O2">
            <title>Programmed Intermittent Epidural Bolus</title>
            <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
        </group_list>
        <measure>
          <title>Average Pain Severity</title>
          <description>Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="5" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 - 48 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 - 72 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="3" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Hypotension</title>
        <description>Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.</description>
        <time_frame>While epidural in place (24 hours postoperatively)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Epidural Infusion</title>
            <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
          <group group_id="O2">
            <title>Programmed Intermittent Epidural Bolus</title>
            <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Hypotension</title>
          <description>Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Worst Reported 24 Hour Pain</title>
        <description>Minimum is 0, maximum is 10. 10 indicates highest pain severity.</description>
        <time_frame>While epidural in place (up to 72 hours postoperatively)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Epidural Infusion</title>
            <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
          <group group_id="O2">
            <title>Programmed Intermittent Epidural Bolus</title>
            <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
        </group_list>
        <measure>
          <title>Worst Reported 24 Hour Pain</title>
          <description>Minimum is 0, maximum is 10. 10 indicates highest pain severity.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="2" upper_limit="7"/>
                    <measurement group_id="O2" value="8" lower_limit="4" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 - 48 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="3" upper_limit="8"/>
                    <measurement group_id="O2" value="6" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 - 72 hours postoperativley</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="5" upper_limit="8"/>
                    <measurement group_id="O2" value="6" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Pain Interference</title>
        <description>Minimum is 0, maximum is 10. 10 indicates highest pain interference.</description>
        <time_frame>While epidural in place (up to 72 hours postoperatively)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Epidural Infusion</title>
            <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
          <group group_id="O2">
            <title>Programmed Intermittent Epidural Bolus</title>
            <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
          </group>
        </group_list>
        <measure>
          <title>Average Pain Interference</title>
          <description>Minimum is 0, maximum is 10. 10 indicates highest pain interference.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="3" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 - 48 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 - 72 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data collected from day of surgery until removal of epidural, on average epidurals were removed between day 1 and 3. Rare clinical scenarios, epidurals can remain as long as 7 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Continuous Epidural Infusion</title>
          <description>At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
        </group>
        <group group_id="E2">
          <title>Programmed Intermittent Epidural Bolus</title>
          <description>For the programmed intermittent epidural bolus group:&#xD;
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.&#xD;
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.&#xD;
Bupivacaine&#xD;
Fentanyl</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <description>mean arterial blood pressure less than 60</description>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="52"/>
              </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>
    <point_of_contact>
      <name_or_title>Paul Su</name_or_title>
      <organization>University of California San Francisco</organization>
      <phone>415-885-7246</phone>
      <email>paul.su@Ucsf.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/NCT03307174
org study id: 15-18354
nct id: NCT03307174
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior
      studies in labor epidurals have demonstrated that a programmed intermittent bolus application
      of local anesthesia can improve pain control by reducing the amount of local anesthetic
      required as well as improve patient satisfaction when compared to continuous epidural
      infusions. The effects of programmed intermittent bolus of epidural local anesthetics
      compared to continuous epidural infusions in a surgical setting have yet to be elucidated.
      Our goal is to evaluate the use of programmed intermittent bolus compared to continuous
      epidural infusion in a surgical patient population. We plan to enroll patients already
      undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology,
      urological where epidural anesthesia can be employed. The primary endpoints of the study will
      be the total local anesthetic consumption and total opioid consumption as surrogate markers
      for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional
      measurements, patient satisfaction, and incidence of hypotension.
See brief summary
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Total Local Anesthetic Utilized in First 24 Hours
time frame: In first 24 hours
description: Total local anesthetic consumed while epidural in place, recorded on infusion pump
measure: Total Opioid Consumed
time frame: While epidural in place (up to 72 hours post operatively)
description: Total opioid consumed (intravenous or po) while epidural in place
measure: Patient Satisfaction Score
time frame: While epidural in place (up to 72 hours postoperatively)
description: Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory.
Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.
measure: Average Pain Severity
time frame: While epidural in place (up to 72 hours postoperatively)
description: Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.
measure: Incidence of Hypotension
time frame: While epidural in place (24 hours postoperatively)
description: Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.
measure: Worst Reported 24 Hour Pain
time frame: While epidural in place (up to 72 hours postoperatively)
description: Minimum is 0, maximum is 10. 10 indicates highest pain severity.
measure: Average Pain Interference
time frame: While epidural in place (up to 72 hours postoperatively)
description: Minimum is 0, maximum is 10. 10 indicates highest pain interference.
arm group label: Continuous epidural infusion
arm group type: Active Comparator
description: At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
arm group label: Programmed intermittent epidural bolus
arm group type: Experimental
description: For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
intervention type: Drug
intervention name: Bupivacaine
arm group label: Continuous epidural infusion
arm group label: Programmed intermittent epidural bolus
other name: 0.0625% bupivacaine
intervention type: Drug
intervention name: Fentanyl
arm group label: Continuous epidural infusion
arm group label: Programmed intermittent epidural bolus
other name: 2mcg/ml fentanyl
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthias Behrends, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Pain
mesh term: Fentanyl
mesh term: Bupivacaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 