<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/NCT02222129</url>
  </required_header>
  <id_info>
    <org_study_id>403263-1</org_study_id>
    <secondary_id>BHS120036</secondary_id>
    <nct_id>NCT02222129</nct_id>
  </id_info>
  <brief_title>Efficacy of Liposomal Bupivacaine Versus 0.25% Bupivacaine for Laparoscopic Urologic Surgery</brief_title>
  <official_title>A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Knight, Richard, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Knight, Richard, M.D.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local&#xD;
      injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic&#xD;
      urologic surgeries in an effort to determine which method reduced postoperative opioid use&#xD;
      the most.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liposomal bupivacaine was developed to extend the duration of efficacy of bupivacaine from&#xD;
      the typical 6 - 8 hours up to 72 hours. The prolonged duration of liposomal bupivacaine was&#xD;
      initially demonstrated in mice in 1994. Two randomized controlled trials using liposomal&#xD;
      bupivacaine for bunionectomy and hemorrhoidectomy resulted in FDA approval for its use in&#xD;
      humans. More recently, liposomal bupivacaine has also been found to improve pain control for&#xD;
      patients undergoing total knee arthroplasty. Infiltration of a local anesthetic into&#xD;
      laparoscopic port sites is a common practice that has been shown in some studies to improve&#xD;
      postoperative pain. To compare liposomal bupivacaine and 0.25% bupivacaine for local&#xD;
      analgesia following laparoscopic and robotic urologic surgery, a randomized&#xD;
      comparison-controlled trial was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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 Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay</measure>
    <time_frame>All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.</time_frame>
    <description>Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Pain Scores.</measure>
    <time_frame>All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.</time_frame>
    <description>Visual analog pain scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay.</measure>
    <time_frame>All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.</time_frame>
    <description>Length of hospital stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Opioid Use.</measure>
    <time_frame>All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.</time_frame>
    <description>Time to first opioid use.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">206</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical site infiltration of 0.25% bupivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgical site infiltration of liposomal bupivacaine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <arm_group_label>Bupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>liposomal bupivacaine</intervention_name>
    <arm_group_label>Liposomal bupivacaine</arm_group_label>
    <other_name>Exparel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18-years-old, undergoing laparoscopic urologic surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and/or nursing mothers.&#xD;
&#xD;
          -  Allergy to bupivacaine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard B Knight, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Antonio Uniformed Services Health Education Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baptist Health System</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Healthcare System</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <results_first_submitted>April 6, 2015</results_first_submitted>
  <results_first_submitted_qc>April 6, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 16, 2015</results_first_posted>
  <last_update_submitted>April 6, 2015</last_update_submitted>
  <last_update_submitted_qc>April 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Randomized controlled trial</keyword>
  <keyword>anesthetics-local</keyword>
  <keyword>bupivacaine</keyword>
  <keyword>analgesia</keyword>
  <keyword>Pain, Postoperative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bupivacaine</title>
          <description>Surgical site infiltration of 0.25% bupivacaine.&#xD;
Bupivacaine</description>
        </group>
        <group group_id="P2">
          <title>Liposomal Bupivacaine</title>
          <description>Surgical site infiltration of liposomal bupivacaine.&#xD;
liposomal bupivacaine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Six patients were excluded from the 0.25% bupivacaine group: one for seizures; four for NSAID and/or PCA use; and one for incomplete data. Nine patients were excluded from the liposomal bupivacaine group; one for remaining intubated overnight; four for surgical complications; three for a hospital stay &gt;5 days due to ileus; and one for NSAID use.</population>
      <group_list>
        <group group_id="B1">
          <title>Bupivacaine</title>
          <description>Surgical site infiltration of 0.25% bupivacaine.&#xD;
Bupivacaine</description>
        </group>
        <group group_id="B2">
          <title>Liposomal Bupivacaine</title>
          <description>Surgical site infiltration of liposomal bupivacaine.&#xD;
liposomal bupivacaine</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="94"/>
            <count group_id="B2" value="97"/>
            <count group_id="B3" value="191"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" lower_limit="53" upper_limit="69"/>
                    <measurement group_id="B2" value="62" lower_limit="52" upper_limit="68"/>
                    <measurement group_id="B3" value="63" lower_limit="53" upper_limit="68"/>
                  </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="37"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Pacific Islander</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>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </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="94"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.9" lower_limit="25.6" upper_limit="34.8"/>
                    <measurement group_id="B2" value="28.2" lower_limit="25.5" upper_limit="32.8"/>
                    <measurement group_id="B3" value="28.7" lower_limit="25.6" upper_limit="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay</title>
        <description>Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay</description>
        <time_frame>All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>Surgical site infiltration of 0.25% bupivacaine.&#xD;
Bupivacaine</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>Surgical site infiltration of liposomal bupivacaine.&#xD;
liposomal bupivacaine</description>
          </group>
        </group_list>
        <measure>
          <title>Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay</title>
          <description>Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay</description>
          <units>mg (morphine equivalents)</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="94"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" lower_limit="8.3" upper_limit="30.5"/>
                    <measurement group_id="O2" value="15" lower_limit="6.7" upper_limit="27"/>
                  </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>
            <groups_desc>Statistical analysis was performed using SAS, version 9.2 (Statistical Analysis Software, Cary, NC). All power calculations were at the 80% level with an alpha of 0.05. Based upon opioid consumption data previously reported for robotic-assisted laparoscopic prostatectomy, a sample size of 74 would be necessary to detect a 10 mg difference in morphine equivalents totaled over the entire hospital stay. (Webster TM, Herrell SD, Chang SS, et al. The Journal of Urology 2005;174(3):912-914.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.39</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Pain Scores.</title>
        <description>Visual analog pain scores.</description>
        <time_frame>All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay.</title>
        <description>Length of hospital stay.</description>
        <time_frame>All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Opioid Use.</title>
        <description>Time to first opioid use.</description>
        <time_frame>All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Bupivacaine</title>
          <description>Surgical site infiltration of 0.25% bupivacaine.&#xD;
Bupivacaine</description>
        </group>
        <group group_id="E2">
          <title>Liposomal Bupivacaine</title>
          <description>Surgical site infiltration of liposomal bupivacaine.&#xD;
liposomal bupivacaine</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="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="106"/>
              </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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Richard Knight, MD</name_or_title>
      <organization>USAF</organization>
      <phone>+44 1638 528186</phone>
      <email>richard_b_knight@yahoo.com</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/NCT02222129
org study id: 403263-1
secondary id: BHS120036
nct id: NCT02222129
lead sponsor: 
has dmc: No
A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local
      injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic
      urologic surgeries in an effort to determine which method reduced postoperative opioid use
      the most.
Liposomal bupivacaine was developed to extend the duration of efficacy of bupivacaine from
      the typical 6 - 8 hours up to 72 hours. The prolonged duration of liposomal bupivacaine was
      initially demonstrated in mice in 1994. Two randomized controlled trials using liposomal
      bupivacaine for bunionectomy and hemorrhoidectomy resulted in FDA approval for its use in
      humans. More recently, liposomal bupivacaine has also been found to improve pain control for
      patients undergoing total knee arthroplasty. Infiltration of a local anesthetic into
      laparoscopic port sites is a common practice that has been shown in some studies to improve
      postoperative pain. To compare liposomal bupivacaine and 0.25% bupivacaine for local
      analgesia following laparoscopic and robotic urologic surgery, a randomized
      comparison-controlled trial was performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay
time frame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
description: Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay
measure: Visual Analog Pain Scores.
time frame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
description: Visual analog pain scores.
measure: Length of Hospital Stay.
time frame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
description: Length of hospital stay.
measure: Time to First Opioid Use.
time frame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
description: Time to first opioid use.
arm group label: Bupivacaine
arm group type: Active Comparator
description: Surgical site infiltration of 0.25% bupivacaine.
arm group label: Liposomal bupivacaine
arm group type: Experimental
description: Surgical site infiltration of liposomal bupivacaine.
intervention type: Drug
intervention name: Bupivacaine
arm group label: Bupivacaine
intervention type: Drug
intervention name: liposomal bupivacaine
arm group label: Liposomal bupivacaine
other name: Exparel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard B Knight, MD
role: Principal Investigator
affiliation: San Antonio Uniformed Services Health Education Consortium
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Bupivacaine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 