<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/NCT03794882</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0793</org_study_id>
    <secondary_id>A530900</secondary_id>
    <secondary_id>SMPH/ANESTHESIOLOGY/ANESTHESIO</secondary_id>
    <secondary_id>Protocol Version 8/26/2019</secondary_id>
    <nct_id>NCT03794882</nct_id>
  </id_info>
  <brief_title>Impact of Quadratus Lumborum Block on Recovery Profile After Ventral Hernia Repair</brief_title>
  <official_title>Impact of Preoperative Quadratus Lumborum Block on Recovery Profile After Laparoscopic Ventral Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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>
      Ventral hernia repair may be associated with significant postoperative pain. Pain is&#xD;
      typically managed with intravenous (IV) and oral medications that come with their own risks,&#xD;
      such as nausea, constipation, sedation, respiratory depression, increased bleeding, and/or&#xD;
      kidney or liver dysfunction. The quadratus lumborum peripheral nerve block has been shown to&#xD;
      produce anesthesia of the anterior abdominal wall in the T7 to L1 distribution. This study&#xD;
      aims to evaluate if the addition of the quadratus lumborum peripheral nerve block (QLB) can&#xD;
      improve pain scores, decrease the need for IV and oral pain medications, and/or speed the&#xD;
      patients' return to normal activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current trends in perioperative pain management stress the importance of multimodal analgesia&#xD;
      in an effort to reduce the dependence on opioid pain medications. Adverse effects of opioids&#xD;
      include sedation, respiratory depression, nausea, vomiting, constipation, itching, and, most&#xD;
      importantly, the potential for tolerance and abuse. Multimodal analgesia attempts to utilize&#xD;
      multiple techniques, including medications and nerve block procedures, to improve&#xD;
      postoperative analgesia. Improved postoperative pain control can enable an earlier return to&#xD;
      normal activities for patients, not only improving patient satisfaction, but also reducing&#xD;
      postoperative morbidity and adverse effects of opioids.&#xD;
&#xD;
      Approximately 350,000 to 500,000 ventral hernia repairs are performed each year in the United&#xD;
      States. Surgeries completed laparoscopically are typically performed on an outpatient basis,&#xD;
      allowing patients to return home the same day of surgery and treat their pain independently&#xD;
      with prescribed pain medications. Utilization of a regional anesthesia technique may allow&#xD;
      prolonged numbing of the nerves postoperatively and decrease the reliance on oral pain&#xD;
      medications. Transversus abdominis plane (TAP) blocks have been shown to decrease pain scores&#xD;
      and opioid consumption following ventral hernia repair. Quadratus lumborum (QL) blocks are&#xD;
      newer iterations of the TAP block.&#xD;
&#xD;
      There are currently three types of the QL block, all targeting the thoracolumbar fascia&#xD;
      surrounding the quadratus lumborum muscle. Injection within this fascial plane may allow&#xD;
      local anesthetic spread into the paravertebral space, possibly explaining why QL blocks have&#xD;
      been mapped from the T7 to T12/L1 dermatomes, covering the entire abdomen. Conversely, TAP&#xD;
      blocks have been mapped from the T10 to T12/L1 dermatomes, only covering the abdomen below&#xD;
      the umbilicus. In the first, the Quadratus lumborum 1 block (QL1), the local anesthetic is&#xD;
      injected within the fascial plane lateral to the QL muscle. In the second, the Quadratus&#xD;
      lumborum 2 block (QL2), the needle trajectory is more superficial, and the local anesthetic&#xD;
      is injected along the posterior border of the QL muscle. The third iteration, the Quadratus&#xD;
      lumborum 3 block (QL3), involves a deeper, transmuscular approach with injection along the&#xD;
      anterior border of the QL muscle. Our study would utilize the QL2 approach as the dermatomal&#xD;
      distribution of the QL1 and QL2 blocks appear to be more widespread than the QL3 block, and&#xD;
      the QL2 block may be a safer approach due to the more superficial angle of the needle 3.&#xD;
&#xD;
      Additionally, the QL block has been shown to have a longer duration of analgesia when&#xD;
      directly compared to the TAP block. A study of pediatric lower abdominal surgery revealed&#xD;
      improved pain scores and parent satisfaction with care in the QL group compared to TAP block.&#xD;
      This improvement persisted to the 24 hour mark. In a study of postoperative pain following&#xD;
      cesarean delivery, pain scores were improved and opioid consumption decreased with the QL&#xD;
      block compared to the TAP block. The differences were not significant at the 1 and 6 hour&#xD;
      marks, but were significant at the 12, 24 and 48 hour marks, highlighting the analgesic&#xD;
      duration of the QL block 8.&#xD;
&#xD;
      This study aims to evaluate the efficacy of the QL block using the QL2 approach on recovery&#xD;
      profile after laparoscopic ventral hernia repair, a commonly performed surgery, as well as&#xD;
      contribute to the understanding of the block and its distribution of anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    administrative challenges and complications due to the COVID-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">May 6, 2019</start_date>
  <completion_date type="Actual">March 12, 2020</completion_date>
  <primary_completion_date type="Actual">March 12, 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>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The participant is blinded to the treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Day (POD) 1 Pain Score</measure>
    <time_frame>24 hours</time_frame>
    <description>Pain Score assessed on POD 1 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Score at Rest</measure>
    <time_frame>PACU, POD1, POD2, POD7</time_frame>
    <description>Pain at rest in PACU, and on POD 1, 2, 7 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score With Activity</measure>
    <time_frame>PACU, POD1, POD2, POD7</time_frame>
    <description>Pain with activity in PACU and on POD 1, 2, 7 assessed using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)</measure>
    <time_frame>PACU, POD1, POD2, POD7</time_frame>
    <description>Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Location of Most Severe Pain</measure>
    <time_frame>PACU, POD1, POD2, POD7</time_frame>
    <description>Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in PACU</measure>
    <time_frame>48 hours</time_frame>
    <description>Duration of patients' time in PACU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Time to Discharge</measure>
    <time_frame>72 hours</time_frame>
    <description>Total postoperative time until discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbness Distribution in PACU</measure>
    <time_frame>12 hours</time_frame>
    <description>For patients that underwent QLB, numbness to ice will be assessed by filling a plastic glove with ice water and systematically assessing numbness to cold in the thoracic and lumbar dermatomes by comparing these sites with a reference point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Report Nausea in PACU</measure>
    <time_frame>12 hours</time_frame>
    <description>Patient will be questioned to assess if they have nausea in PACU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Antiemetic Consumption on POD 0 and in PACU</measure>
    <time_frame>12 hours</time_frame>
    <description>Total consumption of antiemetics on POD 0 and in PACU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Presence of Nausea Necessitating Treatment</measure>
    <time_frame>POD1, POD2, POD7</time_frame>
    <description>Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rating of Satisfaction With Perioperative Care</measure>
    <time_frame>POD1, POD2, POD7</time_frame>
    <description>Satisfaction with perioperative care on POD 1, 2, and 7 measured by a Numerical Rating Scale (0-10) with 0 representing no satisfaction and 10 representing high satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams</measure>
    <time_frame>12 hours</time_frame>
    <description>Total consumption of Non-Opioid Analgesics in the PACU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional Analgesics in Milliliters Administered in the Operating Room</measure>
    <time_frame>6 hours</time_frame>
    <description>This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional Analgesics in Milligrams Administered in the Operating Room</measure>
    <time_frame>6 hours</time_frame>
    <description>This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>QLB + Medical Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Medical Management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Quadratus Lumborum Block</intervention_name>
    <description>30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will be injected on both sides of the mid-abdomen posterior to the mid-axillary line.</description>
    <arm_group_label>QLB + Medical Management</arm_group_label>
    <other_name>QLB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Medical Management</intervention_name>
    <description>Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
    <arm_group_label>QLB + Medical Management</arm_group_label>
    <arm_group_label>Standard Medical Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is scheduled for elective laparoscopic ventral hernia repair;&#xD;
&#xD;
          2. The subject is ≥ 18 years and ≤ 80 years;&#xD;
&#xD;
          3. The patient agrees to receive a quadratus lumborum block&#xD;
&#xD;
          4. American Society of Anesthesiologists class 1-3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is &lt; 18 years of age or &gt;80 years of age;&#xD;
&#xD;
          2. Subject is non-English speaking;&#xD;
&#xD;
          3. Subject is known or believed to be pregnant;&#xD;
&#xD;
          4. Subject is a prisoner;&#xD;
&#xD;
          5. Subject has impaired decision-making capacity per discretion of the Investigator;&#xD;
&#xD;
          6. Significant renal, cardiac or hepatic disease per discretion of the investigator;&#xD;
&#xD;
          7. American Society of Anesthesiologists class 4-5;&#xD;
&#xD;
          8. Known hypersensitivity and/or allergies to local anesthetics;&#xD;
&#xD;
          9. Chronic opioid use (daily or almost daily use of opioids for &gt; 3 months at any point&#xD;
             in their lives).&#xD;
&#xD;
         10. Repair of a recurrent ventral hernia&#xD;
&#xD;
         11. Repair of multiple ventral hernias&#xD;
&#xD;
         12. Unobtainable sonographic views&#xD;
&#xD;
         13. Lacking health insurance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Bevil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology Department, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States,53792.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Hospital and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <results_first_submitted>June 28, 2022</results_first_submitted>
  <results_first_submitted_qc>August 24, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2022</results_first_posted>
  <disposition_first_submitted>December 16, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>August 24, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 21, 2022</disposition_first_posted>
  <last_update_submitted>August 24, 2022</last_update_submitted>
  <last_update_submitted_qc>August 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hernia, Ventral</keyword>
  <keyword>Pain, Postoperative</keyword>
  <keyword>Opioid Use</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
  </condition_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>August 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03794882/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>QLB + Medical Management</title>
          <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
        </group>
        <group group_id="P2">
          <title>Standard Medical Management</title>
          <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>QLB + Medical Management</title>
          <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
        </group>
        <group group_id="B2">
          <title>Standard Medical Management</title>
          <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</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="8"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.38" lower_limit="25" upper_limit="68"/>
                    <measurement group_id="B2" value="56.17" lower_limit="40" upper_limit="67"/>
                    <measurement group_id="B3" value="54.69" lower_limit="25" 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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <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_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</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="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>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="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </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="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Day (POD) 1 Pain Score</title>
        <description>Pain Score assessed on POD 1 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.</description>
        <time_frame>24 hours</time_frame>
        <population>Not all participants answered the survey.</population>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Day (POD) 1 Pain Score</title>
          <description>Pain Score assessed on POD 1 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.</description>
          <population>Not all participants answered the survey.</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="8"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7857" spread="1.643"/>
                    <measurement group_id="O2" value="4.015" spread="2.291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score at Rest</title>
        <description>Pain at rest in PACU, and on POD 1, 2, 7 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.</description>
        <time_frame>PACU, POD1, POD2, POD7</time_frame>
        <population>Not all participants answered the survey.</population>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will be injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score at Rest</title>
          <description>Pain at rest in PACU, and on POD 1, 2, 7 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.</description>
          <population>Not all participants answered the survey.</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="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain Score at Rest PACU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5833" spread="2.224"/>
                    <measurement group_id="O2" value="7.12" spread="1.443"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at Rest POD 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.88" spread="1.64"/>
                    <measurement group_id="O2" value="3.50" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at Rest POD 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.33" spread="0.96"/>
                    <measurement group_id="O2" value="3.00" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at Rest POD 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.43" spread="1.03"/>
                    <measurement group_id="O2" value="1.57" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score With Activity</title>
        <description>Pain with activity in PACU and on POD 1, 2, 7 assessed using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.</description>
        <time_frame>PACU, POD1, POD2, POD7</time_frame>
        <population>Not all participants answered survey questions.</population>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score With Activity</title>
          <description>Pain with activity in PACU and on POD 1, 2, 7 assessed using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.</description>
          <population>Not all participants answered survey questions.</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="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain Score with Activity PACU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Pain Score with Activity POD 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.07" spread="2.20"/>
                    <measurement group_id="O2" value="6.75" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Score with Activity POD 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" spread="2.57"/>
                    <measurement group_id="O2" value="5.58" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Score with Activity POD 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5712" spread="2.012"/>
                    <measurement group_id="O2" value="3.670" spread="1.155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)</title>
        <description>Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.</description>
        <time_frame>PACU, POD1, POD2, POD7</time_frame>
        <population>3 participants from the QLB + Management Group did not respond to the 7 day OMME question.</population>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)</title>
          <description>Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.</description>
          <population>3 participants from the QLB + Management Group did not respond to the 7 day OMME question.</population>
          <units>OMME</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Opioid Consumption in PACU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.93" spread="25.65"/>
                    <measurement group_id="O2" value="36.64" spread="16.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Opioid Consumption POD 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.58" spread="15.31"/>
                    <measurement group_id="O2" value="19.50" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Opioid Consumption POD 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.50" spread="17.00"/>
                    <measurement group_id="O2" value="20.50" spread="5.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Opioid Consumption POD 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" spread="79.88"/>
                    <measurement group_id="O2" value="66.5" spread="37.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Location of Most Severe Pain</title>
        <description>Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7.</description>
        <time_frame>PACU, POD1, POD2, POD7</time_frame>
        <population>Two subjects on the expermental protocol and one in the control group were unable to provide the answers to this secondary aim question when asked by the study team.</population>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Location of Most Severe Pain</title>
          <description>Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7.</description>
          <population>Two subjects on the expermental protocol and one in the control group were unable to provide the answers to this secondary aim question when asked by the study team.</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="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PACU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>around navel</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>incision area</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>abdomen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>navel</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>stomach area</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>middle of abomen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>middle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>around navel</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>incision area</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>abdomen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>navel</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>stomach area</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>middle of abomen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>middle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>around navel</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>incision area</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>abdomen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>navel</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>stomach area</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>middle of abomen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>middle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>around navel</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>incision area</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>abdomen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>navel</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>stomach area</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>middle of abomen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>middle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in PACU</title>
        <description>Duration of patients' time in PACU.</description>
        <time_frame>48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Time in PACU</title>
          <description>Duration of patients' time in PACU.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.63" spread="28.58"/>
                    <measurement group_id="O2" value="64.33" spread="26.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Time to Discharge</title>
        <description>Total postoperative time until discharge.</description>
        <time_frame>72 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Time to Discharge</title>
          <description>Total postoperative time until discharge.</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.625" spread="28.58"/>
                    <measurement group_id="O2" value="66.60" spread="26.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numbness Distribution in PACU</title>
        <description>For patients that underwent QLB, numbness to ice will be assessed by filling a plastic glove with ice water and systematically assessing numbness to cold in the thoracic and lumbar dermatomes by comparing these sites with a reference point.</description>
        <time_frame>12 hours</time_frame>
        <population>This question was not asked by the clinical team at 12 hours and therefore, no data can be entered for this aim.</population>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Numbness Distribution in PACU</title>
          <description>For patients that underwent QLB, numbness to ice will be assessed by filling a plastic glove with ice water and systematically assessing numbness to cold in the thoracic and lumbar dermatomes by comparing these sites with a reference point.</description>
          <population>This question was not asked by the clinical team at 12 hours and therefore, no data can be entered for this aim.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Report Nausea in PACU</title>
        <description>Patient will be questioned to assess if they have nausea in PACU.</description>
        <time_frame>12 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Report Nausea in PACU</title>
          <description>Patient will be questioned to assess if they have nausea 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="8"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Antiemetic Consumption on POD 0 and in PACU</title>
        <description>Total consumption of antiemetics on POD 0 and in PACU.</description>
        <time_frame>12 hours</time_frame>
        <population>This secondary aim was not asked/followed up by the PI and therefore, the subjects were not asked this question and no data was collected for either time point.</population>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Total Antiemetic Consumption on POD 0 and in PACU</title>
          <description>Total consumption of antiemetics on POD 0 and in PACU.</description>
          <population>This secondary aim was not asked/followed up by the PI and therefore, the subjects were not asked this question and no data was collected for either time point.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Presence of Nausea Necessitating Treatment</title>
        <description>Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7</description>
        <time_frame>POD1, POD2, POD7</time_frame>
        <population>Data was not collected from all participants.</population>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Presence of Nausea Necessitating Treatment</title>
          <description>Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7</description>
          <population>Data was not collected from all participants.</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POD 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rating of Satisfaction With Perioperative Care</title>
        <description>Satisfaction with perioperative care on POD 1, 2, and 7 measured by a Numerical Rating Scale (0-10) with 0 representing no satisfaction and 10 representing high satisfaction.</description>
        <time_frame>POD1, POD2, POD7</time_frame>
        <population>Not all participants responded to the survey question.</population>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Rating of Satisfaction With Perioperative Care</title>
          <description>Satisfaction with perioperative care on POD 1, 2, and 7 measured by a Numerical Rating Scale (0-10) with 0 representing no satisfaction and 10 representing high satisfaction.</description>
          <population>Not all participants responded to the survey question.</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="7"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Rating of Satisfaction with perioperative care POD 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.60" spread="0.97"/>
                    <measurement group_id="O2" value="9.20" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rating of Satisfaction with perioperative care POD 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.83" spread="0.96"/>
                    <measurement group_id="O2" value="9.17" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rating of Satisfaction with perioperative care POD 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.21" spread="1.096"/>
                    <measurement group_id="O2" value="8.61" spread="1.768"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams</title>
        <description>Total consumption of Non-Opioid Analgesics in the PACU.</description>
        <time_frame>12 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams</title>
          <description>Total consumption of Non-Opioid Analgesics in the PACU.</description>
          <units>milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ketorolac</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="5" spread="12.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>lidocaine in mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>acetaminophen in mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="235.71" spread="415.04"/>
                    <measurement group_id="O2" value="333.33" spread="440.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Additional Analgesics in Milliliters Administered in the Operating Room</title>
        <description>This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room.</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Additional Analgesics in Milliliters Administered in the Operating Room</title>
          <description>This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room.</description>
          <units>milliliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="15.00" spread="16.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Additional Analgesics in Milligrams Administered in the Operating Room</title>
        <description>This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room.</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>QLB + Medical Management</title>
            <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Standard Medical Management</title>
            <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Additional Analgesics in Milligrams Administered in the Operating Room</title>
          <description>This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room.</description>
          <units>milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ketorolac</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.57" spread="8.02"/>
                    <measurement group_id="O2" value="2.50" spread="6.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acetaminophen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166.67" spread="408.25"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Propofol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="28.33" spread="69.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>lidocaine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.50" spread="36.15"/>
                    <measurement group_id="O2" value="20.00" spread="40.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to Post-operative day 7 (POD7)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>QLB + Medical Management</title>
          <description>Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Quadratus Lumborum Block: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</description>
        </group>
        <group group_id="E2">
          <title>Standard Medical Management</title>
          <description>Subjects will receive Intervention: Procedure: Standard Medical Management as needed.&#xD;
Standard Medical Management: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </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="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>incision site bleeding</sub_title>
                <description>The subject reported incision site bleeding and tiredness at the 7 day time period.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>tiredness</sub_title>
                <description>Overall tiredness</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was terminated early due to the combined effects of the COVID-19 pandemic and the switching of the primary location for the procedure from UW Hospital to East Madison Hospital.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Kristin Bevil</name_or_title>
      <organization>University of Wisconsin-Madison</organization>
      <phone>6082638100</phone>
      <email>kbevil@wisc.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/NCT03794882
org study id: 2018-0793
secondary id: A530900
secondary id: SMPH/ANESTHESIOLOGY/ANESTHESIO
secondary id: Protocol Version 8/26/2019
nct id: NCT03794882
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Ventral hernia repair may be associated with significant postoperative pain. Pain is
      typically managed with intravenous (IV) and oral medications that come with their own risks,
      such as nausea, constipation, sedation, respiratory depression, increased bleeding, and/or
      kidney or liver dysfunction. The quadratus lumborum peripheral nerve block has been shown to
      produce anesthesia of the anterior abdominal wall in the T7 to L1 distribution. This study
      aims to evaluate if the addition of the quadratus lumborum peripheral nerve block (QLB) can
      improve pain scores, decrease the need for IV and oral pain medications, and/or speed the
      patients' return to normal activity.
Current trends in perioperative pain management stress the importance of multimodal analgesia
      in an effort to reduce the dependence on opioid pain medications. Adverse effects of opioids
      include sedation, respiratory depression, nausea, vomiting, constipation, itching, and, most
      importantly, the potential for tolerance and abuse. Multimodal analgesia attempts to utilize
      multiple techniques, including medications and nerve block procedures, to improve
      postoperative analgesia. Improved postoperative pain control can enable an earlier return to
      normal activities for patients, not only improving patient satisfaction, but also reducing
      postoperative morbidity and adverse effects of opioids.

      Approximately 350,000 to 500,000 ventral hernia repairs are performed each year in the United
      States. Surgeries completed laparoscopically are typically performed on an outpatient basis,
      allowing patients to return home the same day of surgery and treat their pain independently
      with prescribed pain medications. Utilization of a regional anesthesia technique may allow
      prolonged numbing of the nerves postoperatively and decrease the reliance on oral pain
      medications. Transversus abdominis plane (TAP) blocks have been shown to decrease pain scores
      and opioid consumption following ventral hernia repair. Quadratus lumborum (QL) blocks are
      newer iterations of the TAP block.

      There are currently three types of the QL block, all targeting the thoracolumbar fascia
      surrounding the quadratus lumborum muscle. Injection within this fascial plane may allow
      local anesthetic spread into the paravertebral space, possibly explaining why QL blocks have
      been mapped from the T7 to T12/L1 dermatomes, covering the entire abdomen. Conversely, TAP
      blocks have been mapped from the T10 to T12/L1 dermatomes, only covering the abdomen below
      the umbilicus. In the first, the Quadratus lumborum 1 block (QL1), the local anesthetic is
      injected within the fascial plane lateral to the QL muscle. In the second, the Quadratus
      lumborum 2 block (QL2), the needle trajectory is more superficial, and the local anesthetic
      is injected along the posterior border of the QL muscle. The third iteration, the Quadratus
      lumborum 3 block (QL3), involves a deeper, transmuscular approach with injection along the
      anterior border of the QL muscle. Our study would utilize the QL2 approach as the dermatomal
      distribution of the QL1 and QL2 blocks appear to be more widespread than the QL3 block, and
      the QL2 block may be a safer approach due to the more superficial angle of the needle 3.

      Additionally, the QL block has been shown to have a longer duration of analgesia when
      directly compared to the TAP block. A study of pediatric lower abdominal surgery revealed
      improved pain scores and parent satisfaction with care in the QL group compared to TAP block.
      This improvement persisted to the 24 hour mark. In a study of postoperative pain following
      cesarean delivery, pain scores were improved and opioid consumption decreased with the QL
      block compared to the TAP block. The differences were not significant at the 1 and 6 hour
      marks, but were significant at the 12, 24 and 48 hour marks, highlighting the analgesic
      duration of the QL block 8.

      This study aims to evaluate the efficacy of the QL block using the QL2 approach on recovery
      profile after laparoscopic ventral hernia repair, a commonly performed surgery, as well as
      contribute to the understanding of the block and its distribution of anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
masking description: The participant is blinded to the treatment.
measure: Postoperative Day (POD) 1 Pain Score
time frame: 24 hours
description: Pain Score assessed on POD 1 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.
measure: Pain Score at Rest
time frame: PACU, POD1, POD2, POD7
description: Pain at rest in PACU, and on POD 1, 2, 7 using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.
measure: Pain Score With Activity
time frame: PACU, POD1, POD2, POD7
description: Pain with activity in PACU and on POD 1, 2, 7 assessed using a Numerical Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents the worst pain imaginable.
measure: Opioid Consumption in Oral Morphine Milligram Equivalent (OMME)
time frame: PACU, POD1, POD2, POD7
description: Opioid Consumption in morphine equivalents in PACU and on POD, 1, 2, 7.
measure: Location of Most Severe Pain
time frame: PACU, POD1, POD2, POD7
description: Location of most severe pain on assessed by questioning the patient in PACU and on POD 1, 2, 7.
measure: Time in PACU
time frame: 48 hours
description: Duration of patients' time in PACU.
measure: Postoperative Time to Discharge
time frame: 72 hours
description: Total postoperative time until discharge.
measure: Numbness Distribution in PACU
time frame: 12 hours
description: For patients that underwent QLB, numbness to ice will be assessed by filling a plastic glove with ice water and systematically assessing numbness to cold in the thoracic and lumbar dermatomes by comparing these sites with a reference point.
measure: Number of Participants Who Report Nausea in PACU
time frame: 12 hours
description: Patient will be questioned to assess if they have nausea in PACU.
measure: Total Antiemetic Consumption on POD 0 and in PACU
time frame: 12 hours
description: Total consumption of antiemetics on POD 0 and in PACU.
measure: Number of Participants With Presence of Nausea Necessitating Treatment
time frame: POD1, POD2, POD7
description: Patient will be questioned to assess if they had nausea necessitating treatment on POD 1, 2, and 7
measure: Rating of Satisfaction With Perioperative Care
time frame: POD1, POD2, POD7
description: Satisfaction with perioperative care on POD 1, 2, and 7 measured by a Numerical Rating Scale (0-10) with 0 representing no satisfaction and 10 representing high satisfaction.
measure: Total Non-Opioid Analgesic Consumption in PACU: Measured in Milligrams
time frame: 12 hours
description: Total consumption of Non-Opioid Analgesics in the PACU.
measure: Additional Analgesics in Milliliters Administered in the Operating Room
time frame: 6 hours
description: This measure describes the amount, in milliliters, of non-opioid analgesics administered in the Operating Room.
measure: Additional Analgesics in Milligrams Administered in the Operating Room
time frame: 6 hours
description: This measure describes the amount, in milligrams, of non-opioid analgesics administered in the Operating Room.
arm group label: QLB + Medical Management
arm group type: Experimental
description: Subjects will undergo Intervention: Procedure/Surgery: Quadratus Lumborum Block and receive Intervention: Procedure: Standard Medical Management as needed.
arm group label: Standard Medical Management
arm group type: Active Comparator
description: Subjects will receive Intervention: Procedure: Standard Medical Management as needed.
intervention type: Combination Product
intervention name: Quadratus Lumborum Block
description: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will be injected on both sides of the mid-abdomen posterior to the mid-axillary line.
arm group label: QLB + Medical Management
other name: QLB
intervention type: Procedure
intervention name: Standard Medical Management
description: Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
arm group label: QLB + Medical Management
arm group label: Standard Medical Management
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kristin Bevil, MD
role: Principal Investigator
affiliation: Anesthesiology Department, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States,53792.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hernia
mesh term: Pain, Postoperative
mesh term: Hernia, Ventral
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was terminated early due to the combined effects of the COVID-19 pandemic and the switching of the primary location for the procedure from UW Hospital to East Madison Hospital.
point of contact: 