<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/NCT03827291</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00091425</org_study_id>
    <nct_id>NCT03827291</nct_id>
  </id_info>
  <brief_title>QL Block With Exparel in Colectomy</brief_title>
  <official_title>Quantitative Observational Comparative Effectiveness of Quadratus Lumborum (QL) Block With Liposomal Bupivacaine (Exparel®) Versus Thoracic Epidural Analgesia in Patients Undergoing Laparoscopic Colectomy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pacira Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if using a different type of injection of local&#xD;
      anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a&#xD;
      quadratus lumborum block) will improve pain control and be easier to manage after surgery&#xD;
      than the current standard of care epidural (spinal injection) pain relief for patients&#xD;
      undergoing laparoscopy colectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants in this study will receive exparel via an abdominal muscle nerve block procedure&#xD;
      immediately prior to their operation. Participants will be in this study for 96 hours&#xD;
      following surgery, which is typically 3 days. During participation, the study staff will&#xD;
      review participant's electronic health records for pain scores and pain medication needs.&#xD;
&#xD;
      Participants that receive the quadratus lumborum block, may experience improved pain control&#xD;
      and/or reduced side effects compared to the epidural pain relief option, but it is not known&#xD;
      yet whether this will be the case.&#xD;
&#xD;
      The most common risk is being sore in the flank where the block was placed. Other risks of&#xD;
      the block rarely occur (less than .5-1%), these can include infection, allergy to the local&#xD;
      anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac&#xD;
      arrest.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2019</start_date>
  <completion_date type="Actual">December 9, 2022</completion_date>
  <primary_completion_date type="Actual">December 2, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Compare efficacy of a quadratus lumborum block performed with liposomal bupivacaine for pain relief after laparoscopic colectomy compared to a historical cohort who received thoracic epidural analgesia.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative opioid consumption over 48 hours</measure>
    <time_frame>Opioid consumption from administration of Exparel to 48 hours post-administration</time_frame>
    <description>Opioid consumption from administration of Exparel to 48 hours post-administration</description>
  </primary_outcome>
  <other_outcome>
    <measure>11-point Numeric Rating Scale (NRS-11)</measure>
    <time_frame>30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration</time_frame>
    <description>Two measures will be taken with each assessment, one at rest and one with coughing. (11-point scale: 10=worst pain imaginable, 0= no pain)</description>
  </other_outcome>
  <other_outcome>
    <measure>Block success</measure>
    <time_frame>30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration</time_frame>
    <description>Presence of demonstrable sensory block over 4 points on the abdomen (one in each of the 4 quadrants), as tested by response to pinprick. Subjects will be asked to report whether the stimulus feels &quot;sharp&quot; or &quot;dull&quot;, indicating block failure and success respectively.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>From administration of Exparel through 168 hours post Exparel administration</time_frame>
    <description>Subjects will be evaluated for potential adverse events related to the block including evidence of hematoma, infection, unexpected sensory or motor deficit, local anesthetic systemic toxicity, as well as transient weakness of the hip flexor muscles (a known possible side-effect of QL block).</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with postoperative pain control</measure>
    <time_frame>From administration of Exparel through 48 hours post Exparel administration</time_frame>
    <description>Overall subject satisfaction with pain control will be recorded on postoperative day 0 and 1 (11-point scale: 10=highly satisfied, 0=completely unsatisfied)</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>From administration of Exparel through hospital discharge</time_frame>
    <description>Measured both by raw length of stay and by time to achieving &quot;discharge readiness&quot;, defined by the presence of 3 criteria: a pain score of 3 or less with ambulation, no opioids required in the preceding 6 hours, and the ability to perform self-care (go to the toilet, dress, and shower).</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of opioid-related adverse events</measure>
    <time_frame>From administration of Exparel through 168 hours post Exparel administration</time_frame>
    <description>Incidence of nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to first mobilization</measure>
    <time_frame>From time of arrival in PACU through first mobilization</time_frame>
    <description>Time to first mobilization</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost</measure>
    <time_frame>From time of arrival in PACU through 96 hours post Exparel administration</time_frame>
    <description>Hospital costs including pharmacy-related costs, costs due to opioid-related adverse events, the cost associated with nursing interventions and drugs to treat opioid-related adverse events, and overall hospital admission costs will be calculated.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>From administration of Exparel through 168 hours post Exparel administration</time_frame>
    <description>Two measures will be taken for sleep quality assessment. How much did pain interfere with falling asleep ( 0= no interference, 10= completely interferes). How much did pain interfere with staying asleep (0= no interference, 10= completely interferes). Measures will be taken once daily from POD 1 to POD 7 (approximately 168hrs. after surgery).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Laparotomy</condition>
  <condition>Colectomy</condition>
  <arm_group>
    <arm_group_label>Quadratus lumborum block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thoracic epidural analgesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Historical cohort that received thoracic epidural analgesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exparel</intervention_name>
    <description>Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.</description>
    <arm_group_label>Quadratus lumborum block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thoracic epidural analgesia</intervention_name>
    <description>Historical cohort that received thoracic epidural analgesia</description>
    <arm_group_label>Thoracic epidural analgesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for elective, laparoscopic colonic resection by one of three&#xD;
             surgeons: Drs. Thacker, Mantyh or Migaly. These surgeons perform this procedure in the&#xD;
             same manner&#xD;
&#xD;
          -  Age 18-85 years&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Physical Class I-III&#xD;
&#xD;
          -  BMI 18-35 kg/m^2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to consent&#xD;
&#xD;
          -  Inability to speak English&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Contraindications to regional blockade: coagulopathy or bleeding diathesis, local&#xD;
             infection, allergy to local anesthetics&#xD;
&#xD;
          -  Allergies/intolerances/contraindications to any of the multimodal agents&#xD;
             (acetaminophen, gabapentin, ketorolac)&#xD;
&#xD;
          -  Daily opioid equivalent use of 30 mg of morphine or greater at time of consent&#xD;
&#xD;
          -  History of drug or alcohol abuse&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion&#xD;
             of the investigator, may interfere with the study assessments of compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda Kumar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <pending_results>
    <submitted>June 22, 2023</submitted>
    <returned>July 12, 2023</returned>
    <submitted>August 8, 2023</submitted>
    <returned>August 29, 2023</returned>
  </pending_results>
  <!-- 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/NCT03827291
org study id: PRO00091425
nct id: NCT03827291
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to determine if using a different type of injection of local
      anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a
      quadratus lumborum block) will improve pain control and be easier to manage after surgery
      than the current standard of care epidural (spinal injection) pain relief for patients
      undergoing laparoscopy colectomy.
Participants in this study will receive exparel via an abdominal muscle nerve block procedure
      immediately prior to their operation. Participants will be in this study for 96 hours
      following surgery, which is typically 3 days. During participation, the study staff will
      review participant's electronic health records for pain scores and pain medication needs.

      Participants that receive the quadratus lumborum block, may experience improved pain control
      and/or reduced side effects compared to the epidural pain relief option, but it is not known
      yet whether this will be the case.

      The most common risk is being sore in the flank where the block was placed. Other risks of
      the block rarely occur (less than .5-1%), these can include infection, allergy to the local
      anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac
      arrest.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Compare efficacy of a quadratus lumborum block performed with liposomal bupivacaine for pain relief after laparoscopic colectomy compared to a historical cohort who received thoracic epidural analgesia.
primary purpose: Treatment
masking: None (Open Label)
measure: Cumulative opioid consumption over 48 hours
time frame: Opioid consumption from administration of Exparel to 48 hours post-administration
description: Opioid consumption from administration of Exparel to 48 hours post-administration
measure: 11-point Numeric Rating Scale (NRS-11)
time frame: 30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration
description: Two measures will be taken with each assessment, one at rest and one with coughing. (11-point scale: 10=worst pain imaginable, 0= no pain)
measure: Block success
time frame: 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration
description: Presence of demonstrable sensory block over 4 points on the abdomen (one in each of the 4 quadrants), as tested by response to pinprick. Subjects will be asked to report whether the stimulus feels "sharp" or "dull", indicating block failure and success respectively.
measure: Adverse Events
time frame: From administration of Exparel through 168 hours post Exparel administration
description: Subjects will be evaluated for potential adverse events related to the block including evidence of hematoma, infection, unexpected sensory or motor deficit, local anesthetic systemic toxicity, as well as transient weakness of the hip flexor muscles (a known possible side-effect of QL block).
measure: Satisfaction with postoperative pain control
time frame: From administration of Exparel through 48 hours post Exparel administration
description: Overall subject satisfaction with pain control will be recorded on postoperative day 0 and 1 (11-point scale: 10=highly satisfied, 0=completely unsatisfied)
measure: Hospital length of stay
time frame: From administration of Exparel through hospital discharge
description: Measured both by raw length of stay and by time to achieving "discharge readiness", defined by the presence of 3 criteria: a pain score of 3 or less with ambulation, no opioids required in the preceding 6 hours, and the ability to perform self-care (go to the toilet, dress, and shower).
measure: Incidence of opioid-related adverse events
time frame: From administration of Exparel through 168 hours post Exparel administration
description: Incidence of nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression
measure: Time to first mobilization
time frame: From time of arrival in PACU through first mobilization
description: Time to first mobilization
measure: Cost
time frame: From time of arrival in PACU through 96 hours post Exparel administration
description: Hospital costs including pharmacy-related costs, costs due to opioid-related adverse events, the cost associated with nursing interventions and drugs to treat opioid-related adverse events, and overall hospital admission costs will be calculated.
measure: Sleep Quality
time frame: From administration of Exparel through 168 hours post Exparel administration
description: Two measures will be taken for sleep quality assessment. How much did pain interfere with falling asleep ( 0= no interference, 10= completely interferes). How much did pain interfere with staying asleep (0= no interference, 10= completely interferes). Measures will be taken once daily from POD 1 to POD 7 (approximately 168hrs. after surgery).
arm group label: Quadratus lumborum block
arm group type: Experimental
description: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
arm group label: Thoracic epidural analgesia
arm group type: Other
description: Historical cohort that received thoracic epidural analgesia.
intervention type: Drug
intervention name: Exparel
description: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
arm group label: Quadratus lumborum block
intervention type: Other
intervention name: Thoracic epidural analgesia
description: Historical cohort that received thoracic epidural analgesia
arm group label: Thoracic epidural analgesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Amanda Kumar, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
submitted: June 22, 2023
returned: July 12, 2023
submitted: August 8, 2023
returned: August 29, 2023