<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/NCT03250507</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 10655</org_study_id>
    <nct_id>NCT03250507</nct_id>
  </id_info>
  <brief_title>Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy</brief_title>
  <official_title>Mixture of Liposomal Bupivicaine and Bupivicaine Hydrogen Chloride (HCl) May Provide Faster and Longer Lasting Analgesia in Transversus Abdominis Block for Patient Having Open Abdominal Hysterectomies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate the effectiveness of different formulations of&#xD;
      bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain&#xD;
      management after open abdominal hysterectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All eligible patients who consent to the study will be randomized to one of three groups.&#xD;
      Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP&#xD;
      block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block&#xD;
      with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in&#xD;
      the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be randomized to one of three study groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The patient, surgical team, nursing team, anesthesia team, and outcomes assessor will be blinded to the group assignment. The anesthetist performing the TAP block will not be blinded to the group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)</measure>
    <time_frame>0 - 72 hours post-operatively</time_frame>
    <description>Total opioid consumption</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given</measure>
    <time_frame>0 - 72 hours post-operatively</time_frame>
    <description>time to first opioid given</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied</measure>
    <time_frame>0 - 72 hours post-operatively</time_frame>
    <description>Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay in the Hospital</measure>
    <time_frame>until the patient is discharged from the hospital</time_frame>
    <description>Length of stay in the hospital, maximum time until discharge from the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Local Anesthetic Toxicity</measure>
    <time_frame>0 - 72 hours post-operatively</time_frame>
    <description>Presence of local anesthetic toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Hypotension &lt; 60 mmHg Mean Arterial Pressure</measure>
    <time_frame>0 - 72 hours post-operatively</time_frame>
    <description>Presence of hemodynamic instability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scores Using Visual Analogue Scale ( 0-10)</measure>
    <time_frame>0-24 postoperative pain scores</time_frame>
    <description>Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Hysterectomy</condition>
  <arm_group>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal bupivacaine and bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>0.25% bupivacaine for TAP block</description>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_label>Liposomal bupivacaine and bupivacaine</arm_group_label>
    <other_name>Marcaine, Sensorcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liposomal bupivacaine</intervention_name>
    <description>Exparel for TAP block</description>
    <arm_group_label>Liposomal bupivacaine</arm_group_label>
    <arm_group_label>Liposomal bupivacaine and bupivacaine</arm_group_label>
    <other_name>Exparel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
    <arm_group_label>Liposomal bupivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective open abdominal hysterectomy with midline incision, age &gt; 18 years, American&#xD;
             Society of Anesthesiologist classification score (ASA classification) 1-3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a chronic pain condition, major unexpected surgical complication,&#xD;
             unexpected prolonged intubation, patient refusal, local anesthetic allergy, any&#xD;
             contraindication to regional anesthesia, greater than 2 attempts by resident and&#xD;
             greater than 1 attempt by staff anesthesiologist for TAP block.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Eligible patients are undergoing open abdominal hysterectomy and therefore are female.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed-Rida Alsaden, MBChB FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>April 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <results_first_submitted>January 27, 2021</results_first_submitted>
  <results_first_submitted_qc>November 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2022</results_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Mohamed Rida Alsaden</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>TAP block</keyword>
  <keyword>Liposomal bupivicaine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual patient data will be available to only study researchers.</ipd_description>
  </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>June 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03250507/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bupivacaine</title>
          <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block</description>
        </group>
        <group group_id="P2">
          <title>Liposomal Bupivacaine</title>
          <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.&#xD;
Liposomal bupivacaine: Exparel for TAP block&#xD;
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
        </group>
        <group group_id="P3">
          <title>Liposomal Bupivacaine and Bupivacaine</title>
          <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block&#xD;
Liposomal bupivacaine: Exparel for TAP block</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>13 patients were excluded from study analysis due to meeting exclusion criteria. N=25 in group Bupi, N = 27 in group Liposomal bupi, and N=25 in group liposomal bupi and bupi. 20 patients were discharged within 72 hr. Data is given for those in the hospital for 24 hr periods. For the period 24-48 hr, n = 24 in group bupivacaine, n = 26 in group liposomal, n = 25 in group mixture. For the period 48-72 hr, n = 18 for group bupivacaine, n = 20 for group liposomal, and n = 19 for group mixture. *</population>
      <group_list>
        <group group_id="B1">
          <title>Bupivacaine</title>
          <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block</description>
        </group>
        <group group_id="B2">
          <title>Liposomal Bupivacaine</title>
          <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.&#xD;
Liposomal bupivacaine: Exparel for TAP block&#xD;
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
        </group>
        <group group_id="B3">
          <title>Liposomal Bupivacaine and Bupivacaine</title>
          <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block&#xD;
Liposomal bupivacaine: Exparel for TAP block</description>
        </group>
        <group group_id="B4">
          <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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="90"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="90"/>
                  </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_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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="90"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)</title>
        <description>Total opioid consumption</description>
        <time_frame>0 - 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.&#xD;
Liposomal bupivacaine: Exparel for TAP block&#xD;
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine and Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block&#xD;
Liposomal bupivacaine: Exparel for TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)</title>
          <description>Total opioid consumption</description>
          <units>mg morphine equivalents</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="208" lower_limit="155" upper_limit="270"/>
                    <measurement group_id="O2" value="203" lower_limit="153" upper_limit="283"/>
                    <measurement group_id="O3" value="202" lower_limit="116" upper_limit="325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given</title>
        <description>time to first opioid given</description>
        <time_frame>0 - 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.&#xD;
Liposomal bupivacaine: Exparel for TAP block&#xD;
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine and Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block&#xD;
Liposomal bupivacaine: Exparel for TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given</title>
          <description>time to first opioid given</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" lower_limit="28" upper_limit="66"/>
                    <measurement group_id="O2" value="63" lower_limit="44" upper_limit="102"/>
                    <measurement group_id="O3" value="51" lower_limit="24" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied</title>
        <description>Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.</description>
        <time_frame>0 - 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.&#xD;
Liposomal bupivacaine: Exparel for TAP block&#xD;
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine and Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block&#xD;
Liposomal bupivacaine: Exparel for TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied</title>
          <description>Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay in the Hospital</title>
        <description>Length of stay in the hospital, maximum time until discharge from the hospital</description>
        <time_frame>until the patient is discharged from the hospital</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.&#xD;
Liposomal bupivacaine: Exparel for TAP block&#xD;
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine and Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block&#xD;
Liposomal bupivacaine: Exparel for TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay in the Hospital</title>
          <description>Length of stay in the hospital, maximum time until discharge from the hospital</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79" lower_limit="61" upper_limit="122"/>
                    <measurement group_id="O2" value="82" lower_limit="72" upper_limit="102"/>
                    <measurement group_id="O3" value="80" lower_limit="76" upper_limit="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Local Anesthetic Toxicity</title>
        <description>Presence of local anesthetic toxicity</description>
        <time_frame>0 - 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.&#xD;
Liposomal bupivacaine: Exparel for TAP block&#xD;
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine and Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block&#xD;
Liposomal bupivacaine: Exparel for TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Local Anesthetic Toxicity</title>
          <description>Presence of local anesthetic toxicity</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="25"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Hypotension &lt; 60 mmHg Mean Arterial Pressure</title>
        <description>Presence of hemodynamic instability</description>
        <time_frame>0 - 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.&#xD;
Liposomal bupivacaine: Exparel for TAP block&#xD;
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine and Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block&#xD;
Liposomal bupivacaine: Exparel for TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Hypotension &lt; 60 mmHg Mean Arterial Pressure</title>
          <description>Presence of hemodynamic instability</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="25"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Scores Using Visual Analogue Scale ( 0-10)</title>
        <description>Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.</description>
        <time_frame>0-24 postoperative pain scores</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.&#xD;
Liposomal bupivacaine: Exparel for TAP block&#xD;
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine and Bupivacaine</title>
            <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block&#xD;
Liposomal bupivacaine: Exparel for TAP block</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scores Using Visual Analogue Scale ( 0-10)</title>
          <description>Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="7" upper_limit="9"/>
                    <measurement group_id="O2" value="7" lower_limit="6" upper_limit="7"/>
                    <measurement group_id="O3" value="7" lower_limit="5" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>72 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bupivacaine</title>
          <description>Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block</description>
        </group>
        <group group_id="E2">
          <title>Liposomal Bupivacaine</title>
          <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.&#xD;
this group will not receive bupivacaine. they receive only liposomal bupivacaine.&#xD;
Liposomal bupivacaine: Exparel for TAP block&#xD;
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.</description>
        </group>
        <group group_id="E3">
          <title>Liposomal Bupivacaine and Bupivacaine</title>
          <description>Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.&#xD;
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.&#xD;
Bupivacaine: 0.25% bupivacaine for TAP block&#xD;
Liposomal bupivacaine: Exparel for TAP block</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Christina Fidkowski, MD</name_or_title>
      <organization>Henry Ford Hospital</organization>
      <phone>313-916-7648</phone>
      <email>cfidkow1@hfhs.org</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/NCT03250507
org study id: IRB 10655
nct id: NCT03250507
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of this study is to evaluate the effectiveness of different formulations of
      bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain
      management after open abdominal hysterectomy.
All eligible patients who consent to the study will be randomized to one of three groups.
      Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP
      block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block
      with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in
      the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized to one of three study groups.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The patient, surgical team, nursing team, anesthesia team, and outcomes assessor will be blinded to the group assignment. The anesthetist performing the TAP block will not be blinded to the group assignment.
measure: Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
time frame: 0 - 72 hours post-operatively
description: Total opioid consumption
measure: Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given
time frame: 0 - 72 hours post-operatively
description: time to first opioid given
measure: Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied
time frame: 0 - 72 hours post-operatively
description: Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.
measure: Length of Stay in the Hospital
time frame: until the patient is discharged from the hospital
description: Length of stay in the hospital, maximum time until discharge from the hospital
measure: Number of Patients With Local Anesthetic Toxicity
time frame: 0 - 72 hours post-operatively
description: Presence of local anesthetic toxicity
measure: Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure
time frame: 0 - 72 hours post-operatively
description: Presence of hemodynamic instability
measure: Pain Scores Using Visual Analogue Scale ( 0-10)
time frame: 0-24 postoperative pain scores
description: Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.
arm group label: Bupivacaine
arm group type: Active Comparator
description: Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
arm group label: Liposomal bupivacaine
arm group type: Active Comparator
description: Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
arm group label: Liposomal bupivacaine and bupivacaine
arm group type: Experimental
description: Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
intervention type: Drug
intervention name: Bupivacaine
description: 0.25% bupivacaine for TAP block
arm group label: Bupivacaine
arm group label: Liposomal bupivacaine and bupivacaine
other name: Marcaine, Sensorcaine
intervention type: Drug
intervention name: Liposomal bupivacaine
description: Exparel for TAP block
arm group label: Liposomal bupivacaine
arm group label: Liposomal bupivacaine and bupivacaine
other name: Exparel
intervention type: Drug
intervention name: Saline
description: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
arm group label: Liposomal bupivacaine
criteria: 
gender: Female
gender based: Yes
gender description: Eligible patients are undergoing open abdominal hysterectomy and therefore are female.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohamed-Rida Alsaden, MBChB FRCPC
role: Principal Investigator
affiliation: Henry Ford Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Mohamed Rida Alsaden
investigator title: Anesthesiologist
mesh term: Bupivacaine
sharing ipd: No
ipd description: Individual patient data will be available to only study researchers.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 