<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/NCT02996227</url>
  </required_header>
  <id_info>
    <org_study_id>16-1449 -EXPLANE Block</org_study_id>
    <nct_id>NCT02996227</nct_id>
  </id_info>
  <brief_title>Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine</brief_title>
  <official_title>Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous&#xD;
      Epidural Analgesia With Bupivacaine&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator goal is to compare the analgesic efficacy of TAP blocks with liposomal&#xD;
      bupivacaine (Exparel) and continuous epidural blocks in patients who are scheduled for major&#xD;
      lower abdominal surgery. To assess whether TAP block with Exparel is noninferior to&#xD;
      continuous epidural analgesia on pain management, defined as noninferior for both pain&#xD;
      control and total opioid consumption for 72 hours, in patients who had major lower abdominal&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VRS Pain score</measure>
    <time_frame>Discharge from PACU until 72 hours after the end of surgery</time_frame>
    <description>Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies worst pain ever experienced. The VRS will be recorded every 30 minutes in the recovery area for the first 2 hours, then every 4 hours thereafter while awake for 72 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total opioid consumption</measure>
    <time_frame>Discharge from PACU until 72 hours after the end of surgery</time_frame>
    <description>Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activity after surgery</measure>
    <time_frame>Discharge from PACU until 72 hours after the end of surgery</time_frame>
    <description>ViSi mobile (Sotera Wireless) patient monitoring system, a platform for comprehensive vital sign monitoring will be used to quantify patient activity over the initial 72 postoperative hours. This system continuously measures position (lying versus sitting) and activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid related side effect</measure>
    <time_frame>The first, second and third postoperative mornings</time_frame>
    <description>We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate opioid-related side effect. ORSDS questionnaires will be administered by a trained research fellow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Discharge from PACU until 72 hours after the end of surgery</time_frame>
    <description>Visi mobile patient monitoring system will be used to obtain blood pressure of the patient for 72 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of recovery after anesthesia</measure>
    <time_frame>The first and third postoperative mornings</time_frame>
    <description>Quality of recovery will be measured using QoR scale. Patients will be questioned on morning of POD1 and 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks</time_frame>
    <description>The length of hospital stay will be measured as days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cost of care</measure>
    <time_frame>From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks</time_frame>
    <description>The total cost of hospital stay will be collected at hospital discharge day or date of death from any cause, which comes first, assessed up to 100 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">532</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Major Abdominal Surgery</condition>
  <arm_group>
    <arm_group_label>TAP block with Exparel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epidural analgesia with Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epidural catheters with an infusion of Bupivacaine standard solution without additives</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP block</intervention_name>
    <description>Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.</description>
    <arm_group_label>TAP block with Exparel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Epidural analgesia</intervention_name>
    <description>Epidural catheters will be inserted preoperatively.</description>
    <arm_group_label>Epidural analgesia with Bupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EXPAREL</intervention_name>
    <description>Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.</description>
    <arm_group_label>TAP block with Exparel</arm_group_label>
    <other_name>Liposomal Bupivacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.</description>
    <arm_group_label>Epidural analgesia with Bupivacaine</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  18-85 years old&#xD;
&#xD;
          -  ASA Physical Status 1-3&#xD;
&#xD;
          -  Scheduled for elective open or laparoscopic abdominal surgery, including colorectal&#xD;
             and hysterectomy surgeries&#xD;
&#xD;
          -  Anticipated hospitalization of three nights&#xD;
&#xD;
          -  Expected requirement for parenteral opioids for at least 72 hours for postoperative&#xD;
             pain&#xD;
&#xD;
          -  Able to use IV PCA systems.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hepatic disease, e.g. twice the normal levels of liver enzymes&#xD;
&#xD;
          -  Kidney disease, e.g. twice the normal level of serum creatinine&#xD;
&#xD;
          -  Bupivacaine sensitivity or known allergy&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Anticoagulants considered to be a contraindication for epidural or TAP blocks.&#xD;
&#xD;
          -  Surgeries with high port sites will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</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>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02996227
org study id: 16-1449 -EXPLANE Block
nct id: NCT02996227
lead sponsor: 
has dmc: Yes
Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous
      Epidural Analgesia With Bupivacaine
The investigator goal is to compare the analgesic efficacy of TAP blocks with liposomal
      bupivacaine (Exparel) and continuous epidural blocks in patients who are scheduled for major
      lower abdominal surgery. To assess whether TAP block with Exparel is noninferior to
      continuous epidural analgesia on pain management, defined as noninferior for both pain
      control and total opioid consumption for 72 hours, in patients who had major lower abdominal
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: VRS Pain score
time frame: Discharge from PACU until 72 hours after the end of surgery
description: Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies worst pain ever experienced. The VRS will be recorded every 30 minutes in the recovery area for the first 2 hours, then every 4 hours thereafter while awake for 72 hours.
measure: Total opioid consumption
time frame: Discharge from PACU until 72 hours after the end of surgery
description: Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery.
measure: Activity after surgery
time frame: Discharge from PACU until 72 hours after the end of surgery
description: ViSi mobile (Sotera Wireless) patient monitoring system, a platform for comprehensive vital sign monitoring will be used to quantify patient activity over the initial 72 postoperative hours. This system continuously measures position (lying versus sitting) and activity.
measure: Opioid related side effect
time frame: The first, second and third postoperative mornings
description: We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate opioid-related side effect. ORSDS questionnaires will be administered by a trained research fellow.
measure: Blood pressure
time frame: Discharge from PACU until 72 hours after the end of surgery
description: Visi mobile patient monitoring system will be used to obtain blood pressure of the patient for 72 hours.
measure: Quality of recovery after anesthesia
time frame: The first and third postoperative mornings
description: Quality of recovery will be measured using QoR scale. Patients will be questioned on morning of POD1 and 3.
measure: Length of hospital stay
time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks
description: The length of hospital stay will be measured as days.
measure: Total cost of care
time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks
description: The total cost of hospital stay will be collected at hospital discharge day or date of death from any cause, which comes first, assessed up to 100 weeks.
arm group label: TAP block with Exparel
arm group type: Experimental
description: Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)
arm group label: Epidural analgesia with Bupivacaine
arm group type: Active Comparator
description: Epidural catheters with an infusion of Bupivacaine standard solution without additives
intervention type: Procedure
intervention name: TAP block
description: Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.
arm group label: TAP block with Exparel
intervention type: Procedure
intervention name: Epidural analgesia
description: Epidural catheters will be inserted preoperatively.
arm group label: Epidural analgesia with Bupivacaine
intervention type: Drug
intervention name: EXPAREL
description: Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.
arm group label: TAP block with Exparel
other name: Liposomal Bupivacaine
intervention type: Drug
intervention name: Bupivacaine
description: Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.
arm group label: Epidural analgesia with Bupivacaine
other name: Marcaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Bupivacaine