<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/NCT03294109</url>
  </required_header>
  <id_info>
    <org_study_id>17-000598</org_study_id>
    <nct_id>NCT03294109</nct_id>
  </id_info>
  <brief_title>Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy</brief_title>
  <official_title>Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A blinded randomized control trial in living kidney donors. The study group will receive a&#xD;
      liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general&#xD;
      anesthesia. The following study variables will be collected postoperatively following arrival&#xD;
      in the post-anesthesia care unit. Current and maximum intensity pain scores will be&#xD;
      documented by nurses in Electronic Health Record (EHR). Total opiate dose consumed every 24&#xD;
      hours will be collected from the EHR and pain diary after discharge. Patient satisfaction&#xD;
      will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire&#xD;
      (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing&#xD;
      notes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a blinded (patients are blinded and all the staff and the nurses who collect data are&#xD;
      also blinded) randomized controlled trial in living kidney donors who have been approved by a&#xD;
      multidisciplinary (nephrology, urology, psychiatry, and social work) team to proceed with&#xD;
      donor nephrectomy. Patients will be approached to participate in the study only after they&#xD;
      have agreed to kidney donation and have been informed of all of the associated risks.&#xD;
      Participants are informed that they can withdraw from kidney donation at any time until they&#xD;
      are in the operating room.&#xD;
&#xD;
      Patients meeting these criteria, who also consent to participate in the study, will be&#xD;
      randomized (standard of care pain medication vs TQL block). The ratio of male to female&#xD;
      patients in each arm will be equal because of the known increased risks for post-operative&#xD;
      nausea/vomiting (PONV) in females. The study group will receive a liposomal bupivacaine TQL&#xD;
      block after the induction of general anesthesia and liposomal bupivacaine transverse&#xD;
      abdominis plane (TAP) block after closure of the midline fascia. All patients including the&#xD;
      control group will have infiltration of the skin edges with bupivacaine. Control patients&#xD;
      will have a TAP block with 5 cc of bupivacaine on both sides. A placebo 22g needle will be&#xD;
      placed at the same site as the TQL block without injection. Intra-operative narcotics will be&#xD;
      administered by the anesthesia team based on standard criteria. All participants will receive&#xD;
      intravenous ketorolac and acetaminophen at the end of the procedure. Intravenous ketorolac&#xD;
      will be continued for 24 hours while hospitalized. Post-operative pain management with&#xD;
      intermittent parenteral and enteral narcotics as needed will be the same in both groups.&#xD;
&#xD;
      Liposomal bupivacaine block administration:&#xD;
&#xD;
      After induction of general anesthesia, surgical team will turn the patient to the lateral&#xD;
      position (final position for surgery). After prep with and drape, investigators will place&#xD;
      ultrasound probe in mid- posterior axillary line, just above iliac crest. The investigators&#xD;
      will identify abdominal wall muscles including external oblique, internal oblique, transverse&#xD;
      abdominis, and quadratus lumborum as well as thoracolumbar fascia with the help of&#xD;
      ultrasound. Then, investigators will insert a 22g nerve block needle and advanced it under&#xD;
      direct guidance of ultrasound until it is below the fascial covering of the quadratus&#xD;
      lumborum muscle layer or its fascia which forms a continuous fascia compartment with&#xD;
      thoracolumbar fascia. After aspiration to rule out intravascular location of the needle,&#xD;
      investigators will be inject 20 mL of liposomal bupivacaine mixed with 10ml of normal saline&#xD;
      under ultrasound guidance, to monitor spread of the injected fluid . The investigators will&#xD;
      aspirate repeatedly every 5cc of local anesthetic. The investigators will remove the needle&#xD;
      upon completion of the injection.&#xD;
&#xD;
      The following study variables will be collected postoperatively following arrival in the&#xD;
      post-anesthesia care unit. Current and maximum intensity pain scores will be documented by&#xD;
      nurses in EHR. Total opiate dose consumed every 24 hours will be collected from the EHR and&#xD;
      pain diary after discharge. Patient satisfaction will be evaluated using the Revised American&#xD;
      Pain Society Patient Outcome Questionnaire (APS-POQ-R) 24 hours' post-procedure. Incidence of&#xD;
      nausea will be extracted from nursing notes&#xD;
&#xD;
      Complications will be documented by anesthesia pain service that will follow these patients&#xD;
      while admitted.&#xD;
&#xD;
      Outpatient use of narcotics, pain assessment, bowel function, sexual function complications&#xD;
      from the block or the donor surgery, and attitudes toward kidney donation will be evaluated&#xD;
      with validated survey instruments. Please see the timeline for the collection of the data&#xD;
      prior to and after kidney donation. The survey data will be collected using secure links to a&#xD;
      REDCap server 3, 5, 10, 30, and 90 days after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">June 24, 2020</completion_date>
  <primary_completion_date type="Actual">June 24, 2020</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Score</measure>
    <time_frame>3 days post-op</time_frame>
    <description>Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Pain Management</measure>
    <time_frame>Day 1</time_frame>
    <description>The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey score on variable &quot;Satisfaction with Pain Treatments.&quot; This is a scale ranging from 0-10, with 0 being extremely dissatisfied, a poor outcome, with pain treatment to 10 being extremely satisfied, a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of patients requiring pre-op scopolamine patch, and number of patients requiring rescue antiemetics in PACU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return of Bowel Function</measure>
    <time_frame>Day 5</time_frame>
    <description>Bowl activity survey asked participants how big a problem the bowel function was after surgery, on a scale of 1 (no problem) to 5 (a big problem).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Experiencing Complications Related to Surgery or Block</measure>
    <time_frame>Duration of inpatient stay, up to 5 days</time_frame>
    <description>Number of participants that experienced a related complication in each arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Use Dose/Day</measure>
    <time_frame>Day 3</time_frame>
    <description>Milligram Morphine Equivalent /day</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Analgesics, Opioid</condition>
  <condition>Analgesics, Non-Narcotic</condition>
  <condition>Physiological Effects of Drugs</condition>
  <condition>Peripheral Nervous System Agents</condition>
  <condition>Patient Satisfaction</condition>
  <condition>Return to Work</condition>
  <condition>Activity, Sexual</condition>
  <arm_group>
    <arm_group_label>study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>liposomal bupivacain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abdominal wall block with liposomal bupivicaine</intervention_name>
    <description>Abdominal wall block with liposomal bupivicaine</description>
    <arm_group_label>study</arm_group_label>
    <other_name>Exparel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing laparoscopic donor nephrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Systemic or local infection at the potential block site.&#xD;
&#xD;
          -  Allergy or hypersensitivity to the local anesthetic,&#xD;
&#xD;
          -  Possible variations in surgical approach to donor nephrectomy other than what is&#xD;
             defined in this protocol.&#xD;
&#xD;
          -  Scarring or anatomic abnormality over the proposed injection site&#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>Siamak Rahman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans a Gritsch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Connie Frank Kidney Transplant Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://dx.doi.org/10.1016/j.jclinane.2015.05.006</url>
    <description>Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty</description>
  </link>
  <reference>
    <citation>Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.</citation>
    <PMID>27891579</PMID>
  </reference>
  <reference>
    <citation>Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.</citation>
    <PMID>28277325</PMID>
  </reference>
  <reference>
    <citation>Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.</citation>
    <PMID>26225500</PMID>
  </reference>
  <reference>
    <citation>Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.</citation>
    <PMID>27429253</PMID>
  </reference>
  <reference>
    <citation>Hansen CK, Dam M, Bendtsen TF, Borglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270. No abstract available.</citation>
    <PMID>26771297</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <results_first_submitted>July 22, 2021</results_first_submitted>
  <results_first_submitted_qc>October 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 5, 2021</results_first_posted>
  <last_update_submitted>December 20, 2021</last_update_submitted>
  <last_update_submitted_qc>December 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Siamak Rahman, MD</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>TQL block, TAP block, donor nephrectomy, pain, patient satisfaction</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>
  <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>May 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03294109/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Prior to randomization, 146 patients signed consent. Of those 146, 137 completed the intake questionnaire, a requirement for the study. Of those 137, 103 were scheduled for surgery.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Study</title>
          <description>ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine:</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>ERAS Plus laparoscopic TAP block</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Underwent Surgery</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study</title>
          <description>ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>ERAS Plus laparoscopic TAP block</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="40"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="92"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <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>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="28"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="18"/>
                  </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="40"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Pain Score</title>
        <description>Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level</description>
        <time_frame>3 days post-op</time_frame>
        <population>Participants who completed pain VAS survey on day 3</population>
        <group_list>
          <group group_id="O1">
            <title>Study</title>
            <description>ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>ERAS Plus laparoscopic TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Score</title>
          <description>Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level</description>
          <population>Participants who completed pain VAS survey on day 3</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.20" spread="1.94"/>
                    <measurement group_id="O2" value="4.62" spread="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Pain Management</title>
        <description>The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey score on variable &quot;Satisfaction with Pain Treatments.&quot; This is a scale ranging from 0-10, with 0 being extremely dissatisfied, a poor outcome, with pain treatment to 10 being extremely satisfied, a better outcome.</description>
        <time_frame>Day 1</time_frame>
        <population>Patients who completed APS-POQ-R survey question &quot;Satisfaction with Pain Treatments&quot; on Day 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Study</title>
            <description>ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>ERAS Plus laparoscopic TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Pain Management</title>
          <description>The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey score on variable &quot;Satisfaction with Pain Treatments.&quot; This is a scale ranging from 0-10, with 0 being extremely dissatisfied, a poor outcome, with pain treatment to 10 being extremely satisfied, a better outcome.</description>
          <population>Patients who completed APS-POQ-R survey question &quot;Satisfaction with Pain Treatments&quot; on Day 1.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="1.9"/>
                    <measurement group_id="O2" value="9.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics</title>
        <description>Number of patients requiring pre-op scopolamine patch, and number of patients requiring rescue antiemetics in PACU.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study</title>
            <description>ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>ERAS Plus laparoscopic TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics</title>
          <description>Number of patients requiring pre-op scopolamine patch, and number of patients requiring rescue antiemetics in PACU.</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="40"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-op Scopolamine patch</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rescue antiemetics in PACU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Return of Bowel Function</title>
        <description>Bowl activity survey asked participants how big a problem the bowel function was after surgery, on a scale of 1 (no problem) to 5 (a big problem).</description>
        <time_frame>Day 5</time_frame>
        <population>Participants who completed the bowel activity survey on Day 5</population>
        <group_list>
          <group group_id="O1">
            <title>Study</title>
            <description>ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine:</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>ERAS Plus laparoscopic TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Return of Bowel Function</title>
          <description>Bowl activity survey asked participants how big a problem the bowel function was after surgery, on a scale of 1 (no problem) to 5 (a big problem).</description>
          <population>Participants who completed the bowel activity survey on Day 5</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1"/>
                    <measurement group_id="O2" value="1.9" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Experiencing Complications Related to Surgery or Block</title>
        <description>Number of participants that experienced a related complication in each arm</description>
        <time_frame>Duration of inpatient stay, up to 5 days</time_frame>
        <population>All enrolled patients receiving surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Study</title>
            <description>ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>ERAS Plus laparoscopic TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Experiencing Complications Related to Surgery or Block</title>
          <description>Number of participants that experienced a related complication in each arm</description>
          <population>All enrolled patients receiving surgery</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Use Dose/Day</title>
        <description>Milligram Morphine Equivalent /day</description>
        <time_frame>Day 3</time_frame>
        <population>Patients whom responded to survey on Day 3</population>
        <group_list>
          <group group_id="O1">
            <title>Study</title>
            <description>ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>ERAS Plus laparoscopic TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Use Dose/Day</title>
          <description>Milligram Morphine Equivalent /day</description>
          <population>Patients whom responded to survey on Day 3</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 MME</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;0 - 5 MMe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;5 - 10 MME</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;10-15 MME</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;15-20 MME</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;20 MME</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During hospitalization, up to 5 days</time_frame>
      <desc>Complications from surgery were collected as adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Study</title>
          <description>ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>ERAS Plus laparoscopic TAP block</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="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <description>Post-operative hypotension in setting of acute blood loss</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incisional hematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Contralateral flank pain and acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Wound seroma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural Effusion requiring aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </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>Siamak Rahman, MD</name_or_title>
      <organization>university of Californiia</organization>
      <phone>310 2678839</phone>
      <email>sirahman@mednet.ucla.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/NCT03294109
org study id: 17-000598
nct id: NCT03294109
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A blinded randomized control trial in living kidney donors. The study group will receive a
      liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general
      anesthesia. The following study variables will be collected postoperatively following arrival
      in the post-anesthesia care unit. Current and maximum intensity pain scores will be
      documented by nurses in Electronic Health Record (EHR). Total opiate dose consumed every 24
      hours will be collected from the EHR and pain diary after discharge. Patient satisfaction
      will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire
      (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing
      notes.
This is a blinded (patients are blinded and all the staff and the nurses who collect data are
      also blinded) randomized controlled trial in living kidney donors who have been approved by a
      multidisciplinary (nephrology, urology, psychiatry, and social work) team to proceed with
      donor nephrectomy. Patients will be approached to participate in the study only after they
      have agreed to kidney donation and have been informed of all of the associated risks.
      Participants are informed that they can withdraw from kidney donation at any time until they
      are in the operating room.

      Patients meeting these criteria, who also consent to participate in the study, will be
      randomized (standard of care pain medication vs TQL block). The ratio of male to female
      patients in each arm will be equal because of the known increased risks for post-operative
      nausea/vomiting (PONV) in females. The study group will receive a liposomal bupivacaine TQL
      block after the induction of general anesthesia and liposomal bupivacaine transverse
      abdominis plane (TAP) block after closure of the midline fascia. All patients including the
      control group will have infiltration of the skin edges with bupivacaine. Control patients
      will have a TAP block with 5 cc of bupivacaine on both sides. A placebo 22g needle will be
      placed at the same site as the TQL block without injection. Intra-operative narcotics will be
      administered by the anesthesia team based on standard criteria. All participants will receive
      intravenous ketorolac and acetaminophen at the end of the procedure. Intravenous ketorolac
      will be continued for 24 hours while hospitalized. Post-operative pain management with
      intermittent parenteral and enteral narcotics as needed will be the same in both groups.

      Liposomal bupivacaine block administration:

      After induction of general anesthesia, surgical team will turn the patient to the lateral
      position (final position for surgery). After prep with and drape, investigators will place
      ultrasound probe in mid- posterior axillary line, just above iliac crest. The investigators
      will identify abdominal wall muscles including external oblique, internal oblique, transverse
      abdominis, and quadratus lumborum as well as thoracolumbar fascia with the help of
      ultrasound. Then, investigators will insert a 22g nerve block needle and advanced it under
      direct guidance of ultrasound until it is below the fascial covering of the quadratus
      lumborum muscle layer or its fascia which forms a continuous fascia compartment with
      thoracolumbar fascia. After aspiration to rule out intravascular location of the needle,
      investigators will be inject 20 mL of liposomal bupivacaine mixed with 10ml of normal saline
      under ultrasound guidance, to monitor spread of the injected fluid . The investigators will
      aspirate repeatedly every 5cc of local anesthetic. The investigators will remove the needle
      upon completion of the injection.

      The following study variables will be collected postoperatively following arrival in the
      post-anesthesia care unit. Current and maximum intensity pain scores will be documented by
      nurses in EHR. Total opiate dose consumed every 24 hours will be collected from the EHR and
      pain diary after discharge. Patient satisfaction will be evaluated using the Revised American
      Pain Society Patient Outcome Questionnaire (APS-POQ-R) 24 hours' post-procedure. Incidence of
      nausea will be extracted from nursing notes

      Complications will be documented by anesthesia pain service that will follow these patients
      while admitted.

      Outpatient use of narcotics, pain assessment, bowel function, sexual function complications
      from the block or the donor surgery, and attitudes toward kidney donation will be evaluated
      with validated survey instruments. Please see the timeline for the collection of the data
      prior to and after kidney donation. The survey data will be collected using secure links to a
      REDCap server 3, 5, 10, 30, and 90 days after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in Pain Score
time frame: 3 days post-op
description: Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level
measure: Patient Satisfaction With Pain Management
time frame: Day 1
description: The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey score on variable "Satisfaction with Pain Treatments." This is a scale ranging from 0-10, with 0 being extremely dissatisfied, a poor outcome, with pain treatment to 10 being extremely satisfied, a better outcome.
measure: Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics
time frame: Day 1
description: Number of patients requiring pre-op scopolamine patch, and number of patients requiring rescue antiemetics in PACU.
measure: Return of Bowel Function
time frame: Day 5
description: Bowl activity survey asked participants how big a problem the bowel function was after surgery, on a scale of 1 (no problem) to 5 (a big problem).
measure: Participants Experiencing Complications Related to Surgery or Block
time frame: Duration of inpatient stay, up to 5 days
description: Number of participants that experienced a related complication in each arm
measure: Opioid Use Dose/Day
time frame: Day 3
description: Milligram Morphine Equivalent /day
arm group label: study
arm group type: Experimental
description: liposomal bupivacain
arm group label: control
arm group type: No Intervention
description: no intervention
intervention type: Drug
intervention name: Abdominal wall block with liposomal bupivicaine
description: Abdominal wall block with liposomal bupivicaine
arm group label: study
other name: Exparel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Siamak Rahman, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Hans a Gritsch, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
url: http://dx.doi.org/10.1016/j.jclinane.2015.05.006
description: Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty
citation: Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.
PMID: 27891579
citation: Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.
PMID: 28277325
citation: Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
PMID: 26225500
citation: Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.
PMID: 27429253
citation: Hansen CK, Dam M, Bendtsen TF, Borglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270. No abstract available.
PMID: 26771297
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Siamak Rahman, MD
investigator title: Clinical Professor
mesh term: Pain, Postoperative
mesh term: Bupivacaine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 