xml: <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/NCT05972018</url>
    </required_header>
    <id_info>
      <org_study_id>HHC-2023-0134</org_study_id>
      <nct_id>NCT05972018</nct_id>
    </id_info>
    <brief_title>Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters</brief_title>
    <acronym>EXODUS</acronym>
    <official_title>Liposomal Bupivacaine/Bupivacaine A Single-Dose Bilateral Rectus Sheath Blocks Vs. Ropivacaine in Bilateral RS Blocks And Catheters, Comparing Pain Scores And Opioid Use Following Open Abdominal Vascular Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hartford Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hartford Hospital</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 goal of this randomized clinical trial is to learn about receiving a single dose of&#xD;
        liposomal bupivacaine/bupivacaine mixture through bilateral rectus sheath blocks compared to&#xD;
        the standard of care in patients undergoing vascular surgery with an open mid-abdominal&#xD;
        laparotomy incision. The main question it aims to answer is to determine the difference in&#xD;
        the highest, lowest, average, and current pain scores reported at the end of 24-48&#xD;
        postoperative hours using the brief pain inventory-short form (BPI-SF).&#xD;
  &#xD;
        Participants will be randomized to either receive a single dose of liposomal&#xD;
        bupivacaine/bupivacaine mixture intraoperatively at the end of surgery through bilateral&#xD;
        rectus sheath blocks (LB/B group) or to receive the standard of care ropivacaine&#xD;
        intraoperatively at the end of surgery through bilateral rectus sheath blocks with the&#xD;
        insertion of bilateral RS catheter for continuous ropivacaine infusion plus repeated daily&#xD;
        boluses (Catheter group; standard care) to see if there is a difference in outcomes such as&#xD;
        postoperative pain scores, opioid consumption, hospital and PACU length of stay, patient's&#xD;
        satisfaction, and quality of recovery. Additionally, to compare the resources consumed by&#xD;
        each intervention, specifically the medication cost (ropivacaine vs. LB/bupivacaine mixture),&#xD;
        block and catheter supply, and the length of staff time providing rectus sheath block and&#xD;
        catheter over the hospital stay.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>A prospective, single-center, open-label, interventional randomized controlled trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The maximum, average, minimum, and current pain scores at the end of the period 24-48 post-op hours</measure>
      <time_frame>At the end of the 24 - 48 post-op hours</time_frame>
      <description>The maximum, average, minimum, and current pain scores for the past 24 hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants at the end of 24-48 post-op hours using the validated tool; Brief Pain Inventory-Short Form.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Other postoperative pain scores.</measure>
      <time_frame>Up to 168 postoperative hours and at 2 weeks after discharge</time_frame>
      <description>The maximum, average, minimum, and current pain scores for the past 24 hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants, daily and up to the end of the 168 postoperative hours and at 2 weeks after discharge using the validated tool; Brief Pain Inventory-Short Form.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time to extubation</measure>
      <time_frame>From anesthesia end date and time to the date and time of extubation, assessed up to 168 postoperative hours</time_frame>
      <description>The time to extubation: from anesthesia end time to the time of removing the endotracheal tube in the Intensive Care Unit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraop, postop, and total opioid consumption</measure>
      <time_frame>Up to 2 weeks after discharge</time_frame>
      <description>The intraoperative, postoperative, and total opioid consumption during hospitalization measured using morphine milliequivalent doses (MME). Also, if any difference in the time from last opioid given intraop. to the first rescue opioid after surgery. Finally, to compare the incidence of opioid refills, and opioid use (yes/no) at 2 weeks after discharge between the groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital and Post Anesthesia Care Unit (PACU) or Intensive Care Unit (ICU) length of stay (LOS)</measure>
      <time_frame>From the date and time of admission to the date and time of discharge, up to 2 weeks.</time_frame>
      <description>Determine whether patients receiving ropivacaine in RSC versus B/LB in RSB have any the difference in the duration of PACU or ICU stays, in addition to the duration of hospitalization if &gt; or &lt; 7 days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The occurrence of block-related and catheter-related complications, or local anesthetics-related adverse events up to hospital discharge or up to one week).</measure>
      <time_frame>From the date of the block until the date of discharge, assessed up to 1 week</time_frame>
      <description>Determine whether patients receiving ropivacaine in rectus sheath catheter versus Bupivacaine/Liposomal Bupivacaine in rectus sheath block have any difference in the occurrence of any related complications or adverse events up to hospital discharge or up to one week.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital readmission and ED visits</measure>
      <time_frame>up to 2 weeks after discharge</time_frame>
      <description>Incidences of hospital readmission and emergency visits within 2 weeks after discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative nausea and vomiting</measure>
      <time_frame>Up to 168 postoperative hours</time_frame>
      <description>Compare the occurrence of postoperative nausea and vomiting using the Simplified Postoperative Nausea and Vomiting Impact Scale which consists of two questions, with a possible response total score of 0-6. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This scale will be used daily through the duration of in-hospital care (1-7 days)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-40 Questionnaire</measure>
      <time_frame>On postop day 4, postop day 7, and at 2 weeks after the 168 postoperative hours</time_frame>
      <description>Determine any differences between the two groups in the quality of recovery using the &quot;Quality of Recovery Questionnaire-40 questionnaire&quot; which consists of 40 questions categorized into 5 dimensions; emotional state (9 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (5 questions), and pain (7 questions). All questions scored from 1-5; positive items are scored from 1 (worst) to 5 (best); whereas scores are reversed for negative items 1 (best) to 5 (worst).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensory function test</measure>
      <time_frame>Up to the end of the 168 postoperative hour</time_frame>
      <description>to compare any difference in the sensory function test that will be performed at the site of the block and catheter at the PACU and every postoperative day up to the end of the 168 postoperative hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antiemetics use</measure>
      <time_frame>Up to 168 postoperative hour</time_frame>
      <description>The time from the intraoperative standard of care antiemetic dose to the first postoperative use of antiemetic and the number of antiemetic use at any time throughout hospitalization up to 1 week.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction with pain management using CSAT</measure>
      <time_frame>at the end of 168 postoperative hours and at 2 weeks after the 168 postoperative hours</time_frame>
      <description>Patient satisfaction with pain management after surgery using the CSAT score: 5 very satisfied, 4 satisfied, 3 neutral, 2 unsatisfied, 1 very unsatisfied. this assessment on the day of discharge (estimated 168 postoperative hours) and at 2 weeks after discharge, via a phone call.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Aortic Aneurysm, Abdominal</condition>
    <condition>Abdominal Aortic Occlusion</condition>
    <condition>Aortoiliac Occlusive Disease</condition>
    <condition>Aortic Diseases</condition>
    <arm_group>
      <arm_group_label>RSB LB/B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RSB/RSC Ropivacaine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Rectus Sheath Block: Total 60mL (30mL of 0.5% ropivacaine (1 vial)+ 30mL normal saline + 0.1 mL Epinephrine 1:400,000)&#xD;
  Rectus Sheath Catheter continuous infusion of 0.2% ropivacaine 10mL/hr per side&#xD;
  0.2% ropivacaine boluses of 20mL per side per day</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Liposomal bupivacaine</intervention_name>
      <description>Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)</description>
      <arm_group_label>RSB LB/B</arm_group_label>
      <other_name>Bupivacaine</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ropivacaine</intervention_name>
      <description>Total 60mLof 0.25% ropivacaine: (30mL of 0.5% ropivacaine (1 vial)+ 30mL normal saline + 0.1 mL Epinephrine 1:400,000)</description>
      <arm_group_label>RSB/RSC Ropivacaine</arm_group_label>
      <other_name>Epinephrine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients age 18-80 years&#xD;
  &#xD;
            2. Patients scheduled for elective vascular surgery with an open mid-abdominal laparotomy&#xD;
               incision&#xD;
  &#xD;
            3. Patients who are able to speak and read English&#xD;
  &#xD;
            4. Patients with American Society of Anesthesiology (ASA) physical status score I-IV&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Emergency vascular reconstruction surgery.&#xD;
  &#xD;
            2. Patients with contraindications to RSB, including but not limited to anatomical&#xD;
               abnormality, previous surgical intervention that limits or prevents receiving&#xD;
               bilateral RSBs, or infection at the injection site.&#xD;
  &#xD;
            3. History of allergy to local anesthetics.&#xD;
  &#xD;
            4. Patients with a current bleeding disorder or active ongoing coagulopathy and/or&#xD;
               current coagulopathic at the time of surgery due to anticoagulants or antiplatelet&#xD;
               use.&#xD;
  &#xD;
            5. Weight &lt; 40 kg, as a combination of 20 mL of Bupivacaine 0.25% with 30 mL of LB is&#xD;
               greater than the maximal dose allowed, given concern for local anesthetic toxicity.&#xD;
  &#xD;
            6. Patients who take long-acting opioid medication, or on continuous opioid use &gt; 50 MME&#xD;
               per day for at least 30 days within 90 days prior to surgery.&#xD;
  &#xD;
            7. Patients who have chronic pain syndrome with a recent preoperative consultation with&#xD;
               the chronic pain service. Also, patients with distant metastatic cancers (e.g. bone,&#xD;
               lung, brain) confirmed by CT scan.&#xD;
  &#xD;
            8. Patients with current substance abuse, or history of substance abuse within 3 months,&#xD;
               this includes any illicit drugs (not including marijuana) or excessive alcohol&#xD;
               consumption as defined as 4 or more drinks per day or 8 or more drinks per week for&#xD;
               women and 5 or more drinks per day or 15 or more drinks per week for men.&#xD;
  &#xD;
            9. Lack or refusal to sign the study consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kevin Finkel, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hartford Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aseel Walker, MD</last_name>
      <phone>(860) 972-1778</phone>
      <email>aseel.walker@hhchealth.org</email>
    </overall_contact>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hartford Hospital</investigator_affiliation>
      <investigator_full_name>Kevin Finkel</investigator_full_name>
      <investigator_title>Director of Clinical Research - HH Department of Anesthesiology</investigator_title>
    </responsible_party>
    <keyword>Open abdominal aortic repair surgery</keyword>
    <keyword>Rectus Sheath Block</keyword>
    <keyword>Rectus Sheath Block and Catheter</keyword>
    <keyword>Liposomal Bupivacaine</keyword>
    <keyword>Exparel</keyword>
    <keyword>Ropivacaine continuous infusion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aneurysm</mesh_term>
      <mesh_term>Aortic Aneurysm</mesh_term>
      <mesh_term>Aortic Diseases</mesh_term>
      <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epinephrine</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
      <mesh_term>Ropivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972018
  org study id: HHC-2023-0134
  nct id: NCT05972018
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this randomized clinical trial is to learn about receiving a single dose of
        liposomal bupivacaine/bupivacaine mixture through bilateral rectus sheath blocks compared to
        the standard of care in patients undergoing vascular surgery with an open mid-abdominal
        laparotomy incision. The main question it aims to answer is to determine the difference in
        the highest, lowest, average, and current pain scores reported at the end of 24-48
        postoperative hours using the brief pain inventory-short form (BPI-SF).
  
        Participants will be randomized to either receive a single dose of liposomal
        bupivacaine/bupivacaine mixture intraoperatively at the end of surgery through bilateral
        rectus sheath blocks (LB/B group) or to receive the standard of care ropivacaine
        intraoperatively at the end of surgery through bilateral rectus sheath blocks with the
        insertion of bilateral RS catheter for continuous ropivacaine infusion plus repeated daily
        boluses (Catheter group; standard care) to see if there is a difference in outcomes such as
        postoperative pain scores, opioid consumption, hospital and PACU length of stay, patient's
        satisfaction, and quality of recovery. Additionally, to compare the resources consumed by
        each intervention, specifically the medication cost (ropivacaine vs. LB/bupivacaine mixture),
        block and catheter supply, and the length of staff time providing rectus sheath block and
        catheter over the hospital stay.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A prospective, single-center, open-label, interventional randomized controlled trial
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: The maximum, average, minimum, and current pain scores at the end of the period 24-48 post-op hours
  time frame: At the end of the 24 - 48 post-op hours
  description: The maximum, average, minimum, and current pain scores for the past 24 hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants at the end of 24-48 post-op hours using the validated tool; Brief Pain Inventory-Short Form.
  measure: Other postoperative pain scores.
  time frame: Up to 168 postoperative hours and at 2 weeks after discharge
  description: The maximum, average, minimum, and current pain scores for the past 24 hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants, daily and up to the end of the 168 postoperative hours and at 2 weeks after discharge using the validated tool; Brief Pain Inventory-Short Form.
  measure: The time to extubation
  time frame: From anesthesia end date and time to the date and time of extubation, assessed up to 168 postoperative hours
  description: The time to extubation: from anesthesia end time to the time of removing the endotracheal tube in the Intensive Care Unit.
  measure: Intraop, postop, and total opioid consumption
  time frame: Up to 2 weeks after discharge
  description: The intraoperative, postoperative, and total opioid consumption during hospitalization measured using morphine milliequivalent doses (MME). Also, if any difference in the time from last opioid given intraop. to the first rescue opioid after surgery. Finally, to compare the incidence of opioid refills, and opioid use (yes/no) at 2 weeks after discharge between the groups.
  measure: Hospital and Post Anesthesia Care Unit (PACU) or Intensive Care Unit (ICU) length of stay (LOS)
  time frame: From the date and time of admission to the date and time of discharge, up to 2 weeks.
  description: Determine whether patients receiving ropivacaine in RSC versus B/LB in RSB have any the difference in the duration of PACU or ICU stays, in addition to the duration of hospitalization if > or < 7 days.
  measure: The occurrence of block-related and catheter-related complications, or local anesthetics-related adverse events up to hospital discharge or up to one week).
  time frame: From the date of the block until the date of discharge, assessed up to 1 week
  description: Determine whether patients receiving ropivacaine in rectus sheath catheter versus Bupivacaine/Liposomal Bupivacaine in rectus sheath block have any difference in the occurrence of any related complications or adverse events up to hospital discharge or up to one week.
  measure: Hospital readmission and ED visits
  time frame: up to 2 weeks after discharge
  description: Incidences of hospital readmission and emergency visits within 2 weeks after discharge
  measure: Postoperative nausea and vomiting
  time frame: Up to 168 postoperative hours
  description: Compare the occurrence of postoperative nausea and vomiting using the Simplified Postoperative Nausea and Vomiting Impact Scale which consists of two questions, with a possible response total score of 0-6. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This scale will be used daily through the duration of in-hospital care (1-7 days)
  measure: Quality of Recovery-40 Questionnaire
  time frame: On postop day 4, postop day 7, and at 2 weeks after the 168 postoperative hours
  description: Determine any differences between the two groups in the quality of recovery using the "Quality of Recovery Questionnaire-40 questionnaire" which consists of 40 questions categorized into 5 dimensions; emotional state (9 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (5 questions), and pain (7 questions). All questions scored from 1-5; positive items are scored from 1 (worst) to 5 (best); whereas scores are reversed for negative items 1 (best) to 5 (worst).
  measure: Sensory function test
  time frame: Up to the end of the 168 postoperative hour
  description: to compare any difference in the sensory function test that will be performed at the site of the block and catheter at the PACU and every postoperative day up to the end of the 168 postoperative hours.
  measure: Antiemetics use
  time frame: Up to 168 postoperative hour
  description: The time from the intraoperative standard of care antiemetic dose to the first postoperative use of antiemetic and the number of antiemetic use at any time throughout hospitalization up to 1 week.
  measure: Patient satisfaction with pain management using CSAT
  time frame: at the end of 168 postoperative hours and at 2 weeks after the 168 postoperative hours
  description: Patient satisfaction with pain management after surgery using the CSAT score: 5 very satisfied, 4 satisfied, 3 neutral, 2 unsatisfied, 1 very unsatisfied. this assessment on the day of discharge (estimated 168 postoperative hours) and at 2 weeks after discharge, via a phone call.
  arm group label: RSB LB/B
  arm group type: Experimental
  description: Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)
  arm group label: RSB/RSC Ropivacaine
  arm group type: Active Comparator
  description: Rectus Sheath Block: Total 60mL (30mL of 0.5% ropivacaine (1 vial)+ 30mL normal saline + 0.1 mL Epinephrine 1:400,000)
  Rectus Sheath Catheter continuous infusion of 0.2% ropivacaine 10mL/hr per side
  0.2% ropivacaine boluses of 20mL per side per day
  intervention type: Drug
  intervention name: Liposomal bupivacaine
  description: Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)
  arm group label: RSB LB/B
  other name: Bupivacaine
  intervention type: Drug
  intervention name: Ropivacaine
  description: Total 60mLof 0.25% ropivacaine: (30mL of 0.5% ropivacaine (1 vial)+ 30mL normal saline + 0.1 mL Epinephrine 1:400,000)
  arm group label: RSB/RSC Ropivacaine
  other name: Epinephrine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Kevin Finkel, MD
  role: Principal Investigator
  affiliation: Hartford Hospital
  last name: Aseel Walker, MD
  phone: (860) 972-1778
  email: aseel.walker@hhchealth.org
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  PMID: 10740540
  responsible party type: Principal Investigator
  investigator affiliation: Hartford Hospital
  investigator full name: Kevin Finkel
  investigator title: Director of Clinical Research - HH Department of Anesthesiology
  mesh term: Aneurysm
  mesh term: Aortic Aneurysm
  mesh term: Aortic Diseases
  mesh term: Aortic Aneurysm, Abdominal
  mesh term: Epinephrine
  mesh term: Bupivacaine
  mesh term: Ropivacaine
  sharing ipd: No