<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/NCT02263963</url>
  </required_header>
  <id_info>
    <org_study_id>2013-066</org_study_id>
    <secondary_id>DDI.FY13.07</secondary_id>
    <nct_id>NCT02263963</nct_id>
  </id_info>
  <brief_title>The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.</brief_title>
  <official_title>The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spectrum Health Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spectrum Health Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus&#xD;
      abdominis plane block by assessing the demand of postoperative narcotic, length of hospital&#xD;
      stay and incidence of postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain Score</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 4 days</time_frame>
    <description>Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Narcotic Use</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 4 days</time_frame>
    <description>Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Postoperative Complications.</measure>
    <time_frame>participants will be followed for the duration of hospital stay, and 30 days after discharge.</time_frame>
    <description>Any postoperative complications within 30 days of procedure, including death will be recorded.</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of Hospital Stay.</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 4 days</time_frame>
    <description>Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>TAP Block Experal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No TAP Block</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exparel</intervention_name>
    <description>In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.</description>
    <arm_group_label>TAP Block Experal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP Block</intervention_name>
    <description>no intervention will be done to this arm.</description>
    <arm_group_label>TAP Block Experal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients over the age of 18 years w&#xD;
&#xD;
          2. Elective laparoscopic colorectal resection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients under 18 years.&#xD;
&#xD;
          2. Patients unable to provide informed consent&#xD;
&#xD;
          3. Patients undergoing emergency surgery.&#xD;
&#xD;
          4. Pregnant women&#xD;
&#xD;
          5. Severe liver or kidney disease (GFR 15-29 ml/min)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 2, 2013</study_first_submitted>
  <study_first_submitted_qc>October 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <results_first_submitted>April 13, 2016</results_first_submitted>
  <results_first_submitted_qc>January 31, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 28, 2023</results_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2023</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TAP Block Arm</title>
          <description>Twenty five patients randomized to this arm. A volume of 7.5 ml of bupivacaine liposome injectable suspension was used for each side of the TAP blocks so that a total of 15 ml were utilized. The remaining 5 ml of bupivacaine liposome injectable suspension were diluted with 30 ml of sterile preservative free saline and used for local infiltration of the laparoscopic wound</description>
        </group>
        <group group_id="P2">
          <title>no TAP Block Arm</title>
          <description>Twenty five patients randomized to this arm. did not receive 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="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TAP Block</title>
          <description>Patient received TAP block</description>
        </group>
        <group group_id="B2">
          <title>no TAP Block</title>
          <description>patient did not received TAP block</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </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="62.4" spread="13.9"/>
                    <measurement group_id="B2" value="65.6" spread="12.5"/>
                    <measurement group_id="B3" value="64" spread="1"/>
                  </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="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="25"/>
                  </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="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain Score</title>
        <description>Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 4 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TAP Block</title>
            <description>post op pain score</description>
          </group>
          <group group_id="O2">
            <title>no TAP Block</title>
            <description>postop pain score</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain Score</title>
          <description>Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" lower_limit="0.5" upper_limit="8.5"/>
                    <measurement group_id="O2" value="4.5" lower_limit="0" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Narcotic Use</title>
        <description>Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 4 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TAP Block</title>
            <description>post op narcotic use</description>
          </group>
          <group group_id="O2">
            <title>no TAP Block</title>
            <description>post op narcotic use</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Narcotic Use</title>
          <description>Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" lower_limit="0" upper_limit="311"/>
                    <measurement group_id="O2" value="110" lower_limit="0" upper_limit="461"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Postoperative Complications.</title>
        <description>Any postoperative complications within 30 days of procedure, including death will be recorded.</description>
        <time_frame>participants will be followed for the duration of hospital stay, and 30 days after discharge.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TAP Block</title>
            <description>post op ileus</description>
          </group>
          <group group_id="O2">
            <title>no TAP Block</title>
            <description>post op ileus</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Complications.</title>
          <description>Any postoperative complications within 30 days of procedure, including death will be recorded.</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="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Length of Hospital Stay.</title>
        <description>Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 4 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TAP Block</title>
            <description>length of stay</description>
          </group>
          <group group_id="O2">
            <title>no TAP Block</title>
            <description>length of stay</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay.</title>
          <description>Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="15"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>TAP Block</title>
          <description>adverse event</description>
        </group>
        <group group_id="E2">
          <title>no TAP Block</title>
          <description>adverse event</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </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>Dr. Nezar Jrebi</name_or_title>
      <organization>Spectrum Health</organization>
      <phone>507-271-8284</phone>
      <email>jrebi.nezar@hotmail.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/NCT02263963
org study id: 2013-066
secondary id: DDI.FY13.07
nct id: NCT02263963
lead sponsor: 
has dmc: Yes
The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus
      abdominis plane block by assessing the demand of postoperative narcotic, length of hospital
      stay and incidence of postoperative complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Postoperative Pain Score
time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
description: Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.
measure: Postoperative Narcotic Use
time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
description: Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.
measure: Postoperative Complications.
time frame: participants will be followed for the duration of hospital stay, and 30 days after discharge.
description: Any postoperative complications within 30 days of procedure, including death will be recorded.
measure: Length of Hospital Stay.
time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
description: Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.
arm group label: TAP Block Experal
arm group type: Experimental
description: Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally.
arm group label: No TAP Block
arm group type: No Intervention
intervention type: Drug
intervention name: Exparel
description: In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.
arm group label: TAP Block Experal
intervention type: Procedure
intervention name: TAP Block
description: no intervention will be done to this arm.
arm group label: TAP Block Experal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 