<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/NCT03011333</url>
  </required_header>
  <id_info>
    <org_study_id>HTX-011-211</org_study_id>
    <nct_id>NCT03011333</nct_id>
  </id_info>
  <brief_title>Phase 2B Upper Extremity Nerve Block Study</brief_title>
  <official_title>A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heron Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heron Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled,&#xD;
      multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic&#xD;
      efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via&#xD;
      ultrasound-guided lateral and medial pectoral nerve block before surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2017</start_date>
  <completion_date type="Actual">March 19, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores</measure>
    <time_frame>24 hours</time_frame>
    <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded with activity (NRS-A), raising the hands above the head (with wrists above the crown of the head) for at least 5 seconds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)</measure>
    <time_frame>72 Hours</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">243</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Group 1: HTX-011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: HTX-011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: HTX-011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: HTX-011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5: HTX-011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6: Bupivacaine HCl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine HCl without epinephrine, 50 mg via nerve block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 7: Saline Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline placebo via nerve block.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HTX-011</intervention_name>
    <description>HTX-011 (bupivacaine/meloxicam) via nerve block or instillation.</description>
    <arm_group_label>Group 1: HTX-011</arm_group_label>
    <arm_group_label>Group 2: HTX-011</arm_group_label>
    <arm_group_label>Group 3: HTX-011</arm_group_label>
    <arm_group_label>Group 4: HTX-011</arm_group_label>
    <arm_group_label>Group 5: HTX-011</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine HCl without epinephrine</intervention_name>
    <description>Bupivacaine HCl without epinephrine, 50 mg via nerve block.</description>
    <arm_group_label>Group 6: Bupivacaine HCl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Placebo</intervention_name>
    <description>Saline placebo via nerve block.</description>
    <arm_group_label>Group 7: Saline Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is scheduled to undergo primary bilateral submuscular augmentation mammoplasty with&#xD;
             saline or silicone smooth implants with a volume of 300 to 500 cc, inclusive. Note:&#xD;
             textured implants are not allowed.&#xD;
&#xD;
          -  Has an American Society of Anesthesiologists Physical Status of I, II, or III.&#xD;
&#xD;
          -  Subjects are eligible only if not pregnant, not lactating, not planning to become&#xD;
             pregnant during the study, sterile; or using acceptable contraceptives.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a planned concurrent surgical procedure.&#xD;
&#xD;
          -  Has a planned reconstructive procedure status post breast cancer therapy.&#xD;
&#xD;
          -  Has a pre-existing concurrent acute or chronic painful physical/restrictive condition&#xD;
             expected to require analgesic treatment in the postoperative period for pain.&#xD;
&#xD;
          -  Has a contraindication or a known or suspected history of hypersensitivity or&#xD;
             clinically significant idiosyncratic reaction to required study medication.&#xD;
&#xD;
          -  Has known or suspected daily use of opioids for 7 or more consecutive days within the&#xD;
             previous 6 months.&#xD;
&#xD;
          -  Has taken NSAIDs within 10 days prior to scheduled surgery.&#xD;
&#xD;
          -  Has been administered bupivacaine within 5 days prior to the scheduled surgery.&#xD;
&#xD;
          -  Has been administered any local anesthetic within 72 hours prior to the scheduled&#xD;
             surgery other than to treat an AE that occurs after signing the ICF or for&#xD;
             pretreatment prior to a needle placement.&#xD;
&#xD;
          -  Has initiated treatment with any of the following medications within 1 month prior to&#xD;
             study drug administration or is taking any of these medications to control pain:&#xD;
             selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake&#xD;
             inhibitors (SNRIs), gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 (COX-2)&#xD;
             inhibitors. (Note: If a subject is taking one of these medications for a reason other&#xD;
             than pain control, she must be on a stable scheduled dose [ie, not &quot;as needed&quot;] for at&#xD;
             least 1 month prior to study drug administration.) Anxiolytics prior to surgery are&#xD;
             permitted, if necessary.&#xD;
&#xD;
          -  Has a medical condition that, in the opinion of the Investigator, participating in the&#xD;
             study would pose a health risk to the subject or confound the postoperative&#xD;
             assessments.&#xD;
&#xD;
          -  Has a known history of Hepatitis B, Hepatitis C, or human immunodeficiency virus&#xD;
             (HIV).&#xD;
&#xD;
          -  Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere&#xD;
             with study assessments&#xD;
&#xD;
          -  Has any chronic neuromuscular deficit of either pectoral nerve function or&#xD;
             arm/shoulder/truncal musculature.&#xD;
&#xD;
          -  Has any chronic condition or disease that would compromise neurological or vascular&#xD;
             assessments.&#xD;
&#xD;
          -  Had a malignancy in the last year, with the exception of non-metastatic basal cell or&#xD;
             squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.&#xD;
&#xD;
          -  Has a known or suspected history of drug abuse, a positive drug screen on the day of&#xD;
             surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug&#xD;
             screen who are taking an allowed, prescribed medication that is known to result in a&#xD;
             positive drug test (eg, amphetamine and dextroamphetamine for&#xD;
             attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be&#xD;
             eligible for participation in the study. Subjects taking medical marijuana are not&#xD;
             allowed to participate in the study.&#xD;
&#xD;
          -  Received an investigational product or device in a clinical trial within 30 days or&#xD;
             within 5 elimination half lives.&#xD;
&#xD;
          -  Has undergone 3 or more surgeries in 12 months.&#xD;
&#xD;
          -  Has a body mass index (BMI) &gt;35 kg/m2.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>June 14, 2021</results_first_submitted>
  <results_first_submitted_qc>October 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 29, 2021</results_first_posted>
  <disposition_first_submitted>June 8, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>June 8, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 12, 2018</disposition_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03011333/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03011333/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 243 subjects received study drug.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block</description>
        </group>
        <group group_id="P2">
          <title>Group 2: HTX-011</title>
          <description>HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block</description>
        </group>
        <group group_id="P3">
          <title>Group 3: HTX-011</title>
          <description>HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block</description>
        </group>
        <group group_id="P4">
          <title>Group 4: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block</description>
        </group>
        <group group_id="P5">
          <title>Group 5: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation</description>
        </group>
        <group group_id="P6">
          <title>Group 6: Bupivacaine HCl</title>
          <description>Bupivacaine HCl without epinephrine, 50 mg via nerve block</description>
        </group>
        <group group_id="P7">
          <title>Group 7: Saline Placebo</title>
          <description>Saline placebo via nerve block</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="47"/>
                <participants group_id="P5" count="50"/>
                <participants group_id="P6" count="41"/>
                <participants group_id="P7" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="46"/>
                <participants group_id="P5" count="46"/>
                <participants group_id="P6" count="37"/>
                <participants group_id="P7" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block</description>
        </group>
        <group group_id="B2">
          <title>Group 2: HTX-011</title>
          <description>HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block</description>
        </group>
        <group group_id="B3">
          <title>Group 3: HTX-011</title>
          <description>HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block</description>
        </group>
        <group group_id="B4">
          <title>Group 4: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block</description>
        </group>
        <group group_id="B5">
          <title>Group 5: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation</description>
        </group>
        <group group_id="B6">
          <title>Group 6: Bupivacaine HCl</title>
          <description>Bupivacaine HCl without epinephrine, 50 mg via nerve block</description>
        </group>
        <group group_id="B7">
          <title>Group 7: Saline Placebo</title>
          <description>Saline placebo via nerve block</description>
        </group>
        <group group_id="B8">
          <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="12"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="25"/>
            <count group_id="B4" value="47"/>
            <count group_id="B5" value="50"/>
            <count group_id="B6" value="41"/>
            <count group_id="B7" value="41"/>
            <count group_id="B8" value="243"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="50"/>
                    <measurement group_id="B6" value="41"/>
                    <measurement group_id="B7" value="41"/>
                    <measurement group_id="B8" value="243"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.4" spread="6.56"/>
                    <measurement group_id="B2" value="32.1" spread="8.51"/>
                    <measurement group_id="B3" value="30.5" spread="5.64"/>
                    <measurement group_id="B4" value="30.9" spread="8.08"/>
                    <measurement group_id="B5" value="32.0" spread="8.64"/>
                    <measurement group_id="B6" value="30.4" spread="7.75"/>
                    <measurement group_id="B7" value="31.3" spread="9.03"/>
                    <measurement group_id="B8" value="31.2" spread="8.01"/>
                  </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="12"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="50"/>
                    <measurement group_id="B6" value="41"/>
                    <measurement group_id="B7" value="41"/>
                    <measurement group_id="B8" value="243"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </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="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="17"/>
                    <measurement group_id="B7" value="16"/>
                    <measurement group_id="B8" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="33"/>
                    <measurement group_id="B6" value="24"/>
                    <measurement group_id="B7" value="25"/>
                    <measurement group_id="B8" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="11"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="37"/>
                    <measurement group_id="B6" value="35"/>
                    <measurement group_id="B7" value="32"/>
                    <measurement group_id="B8" value="194"/>
                  </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="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </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="12"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="50"/>
                    <measurement group_id="B6" value="41"/>
                    <measurement group_id="B7" value="41"/>
                    <measurement group_id="B8" value="243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores</title>
        <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded with activity (NRS-A), raising the hands above the head (with wrists above the crown of the head) for at least 5 seconds.</description>
        <time_frame>24 hours</time_frame>
        <population>mITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block</description>
          </group>
          <group group_id="O2">
            <title>Group 2: HTX-011</title>
            <description>HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block</description>
          </group>
          <group group_id="O3">
            <title>Group 3: HTX-011</title>
            <description>HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block</description>
          </group>
          <group group_id="O4">
            <title>Group 4: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block</description>
          </group>
          <group group_id="O5">
            <title>Group 5: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation</description>
          </group>
          <group group_id="O6">
            <title>Group 6: Bupivacaine HCl</title>
            <description>Bupivacaine HCl without epinephrine, 50 mg via nerve block</description>
          </group>
          <group group_id="O7">
            <title>Group 7: Saline Placebo</title>
            <description>Saline placebo via nerve block</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores</title>
          <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded with activity (NRS-A), raising the hands above the head (with wrists above the crown of the head) for at least 5 seconds.</description>
          <population>mITT Population</population>
          <units>pain intensity score*hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="50"/>
                <count group_id="O6" value="41"/>
                <count group_id="O7" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.51" spread="59.462"/>
                    <measurement group_id="O2" value="136.17" spread="58.598"/>
                    <measurement group_id="O3" value="136.76" spread="56.034"/>
                    <measurement group_id="O4" value="116.71" spread="52.622"/>
                    <measurement group_id="O5" value="114.87" spread="48.214"/>
                    <measurement group_id="O6" value="133.83" spread="49.493"/>
                    <measurement group_id="O7" value="151.52" spread="46.213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)</title>
        <time_frame>72 Hours</time_frame>
        <population>mITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block</description>
          </group>
          <group group_id="O2">
            <title>Group 2: HTX-011</title>
            <description>HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block</description>
          </group>
          <group group_id="O3">
            <title>Group 3: HTX-011</title>
            <description>HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block</description>
          </group>
          <group group_id="O4">
            <title>Group 4: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block</description>
          </group>
          <group group_id="O5">
            <title>Group 5: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation</description>
          </group>
          <group group_id="O6">
            <title>Group 6: Bupivacaine HCl</title>
            <description>Bupivacaine HCl without epinephrine, 50 mg via nerve block</description>
          </group>
          <group group_id="O7">
            <title>Group 7: Saline Placebo</title>
            <description>Saline placebo via nerve block</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)</title>
          <population>mITT Population</population>
          <units>Morphine milligram equivalents (MME)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="50"/>
                <count group_id="O6" value="41"/>
                <count group_id="O7" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.71" spread="28.650"/>
                    <measurement group_id="O2" value="24.39" spread="19.878"/>
                    <measurement group_id="O3" value="38.00" spread="19.452"/>
                    <measurement group_id="O4" value="28.84" spread="22.603"/>
                    <measurement group_id="O5" value="37.46" spread="21.452"/>
                    <measurement group_id="O6" value="33.57" spread="23.088"/>
                    <measurement group_id="O7" value="36.38" spread="23.275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 Days.</time_frame>
      <desc>Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block</description>
        </group>
        <group group_id="E2">
          <title>Group 2: HTX-011</title>
          <description>HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block</description>
        </group>
        <group group_id="E3">
          <title>Group 3: HTX-011</title>
          <description>HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block</description>
        </group>
        <group group_id="E4">
          <title>Group 4: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block</description>
        </group>
        <group group_id="E5">
          <title>Group 5: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation</description>
        </group>
        <group group_id="E6">
          <title>Group 6: Bupivacaine HCl</title>
          <description>Bupivacaine HCl without epinephrine, 50 mg via nerve block</description>
        </group>
        <group group_id="E7">
          <title>Group 7: Saline Placebo</title>
          <description>Saline placebo via nerve block</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA">Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device breakage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <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="11" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="43" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="47" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="33" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="35" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="37" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="37" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="26" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="16" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Medical device site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Catheter site inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vice President, Clinical Operations</name_or_title>
      <organization>Heron Therapeutics, Inc.</organization>
      <phone>858-251-7232</phone>
      <email>svisonneau@herontx.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03011333
org study id: HTX-011-211
nct id: NCT03011333
lead sponsor: 
has dmc: No
This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled,
      multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic
      efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via
      ultrasound-guided lateral and medial pectoral nerve block before surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores
time frame: 24 hours
description: Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), raising the hands above the head (with wrists above the crown of the head) for at least 5 seconds.
measure: Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)
time frame: 72 Hours
arm group label: Group 1: HTX-011
arm group type: Experimental
description: HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block.
arm group label: Group 2: HTX-011
arm group type: Experimental
description: HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block.
arm group label: Group 3: HTX-011
arm group type: Experimental
description: HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block.
arm group label: Group 4: HTX-011
arm group type: Experimental
description: HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block.
arm group label: Group 5: HTX-011
arm group type: Experimental
description: HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation.
arm group label: Group 6: Bupivacaine HCl
arm group type: Active Comparator
description: Bupivacaine HCl without epinephrine, 50 mg via nerve block.
arm group label: Group 7: Saline Placebo
arm group type: Placebo Comparator
description: Saline placebo via nerve block.
intervention type: Drug
intervention name: HTX-011
description: HTX-011 (bupivacaine/meloxicam) via nerve block or instillation.
arm group label: Group 1: HTX-011
arm group label: Group 2: HTX-011
arm group label: Group 3: HTX-011
arm group label: Group 4: HTX-011
arm group label: Group 5: HTX-011
intervention type: Drug
intervention name: Bupivacaine HCl without epinephrine
description: Bupivacaine HCl without epinephrine, 50 mg via nerve block.
arm group label: Group 6: Bupivacaine HCl
intervention type: Drug
intervention name: Saline Placebo
description: Saline placebo via nerve block.
arm group label: Group 7: Saline Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Epinephrine
mesh term: Bupivacaine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 