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/NCT05992896</url>
    </required_header>
    <id_info>
      <org_study_id>23-003451</org_study_id>
      <nct_id>NCT05992896</nct_id>
    </id_info>
    <brief_title>A Study of Loco-Regional Liposomal Bupivacaine Injection</brief_title>
    <official_title>Can Loco-regional Anesthesia With Liposomal Bupivacaine Reduce Intra- and Post-operative Narcotic Use in Patients Undergoing Lower Extremity Revascularization? A Prospective, Triple Blinded, Randomized Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research is to find out if using liposomal bupivacaine solution&#xD;
        (bupivacaine liposome) injections during lower extremity revascularization surgery will lower&#xD;
        the amount of narcotic drugs used during and following the procedure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be a single site, triple blinded, controlled randomized trial assessing potential&#xD;
        reduction in narcotic use in patients undergoing lower extremity revascularization, when&#xD;
        loco-regional anesthesia with Exparel solution is performed, compared to normal saline&#xD;
        injection. Loco-regional anesthesia for lower extremity revascularization will include an&#xD;
        ultrasound guided ilio-inguinal block with Exparel solution and local injection in the&#xD;
        wound(s) edges of more Exparel solution. The control group will receive injection of normal&#xD;
        saline instead. Lower extremity revascularizations will include femoral endarterectomy with&#xD;
        patching ± antegrade or retrograde endovascular intervention (one or more combination of&#xD;
        stenting, atherectomy, balloon angioplasty) or bypass (femoral popliteal or femoral tibial&#xD;
        bypasses with vein or prosthetic graft).&#xD;
  &#xD;
        The study will be conducted at Mayo Clinic Health System in Eau Claire only (single site).&#xD;
  &#xD;
        The enrolled patients will be medicated in pre- and intra-operative phases by the anesthesia&#xD;
        team in a standardized fashion, based on the protocol in attachment 4.&#xD;
  &#xD;
        Patient, surgeon, and the team assessing the patient postoperatively will be blinded (triple&#xD;
        blinded). Normal saline will be opacified by the pharmacy to keep the surgeon unaware of what&#xD;
        he/she is injecting. As per Mayo policy, all patients will receive the surgical bill at least&#xD;
        30 days after surgery. This time frame will allow the patient to remain blinded if he/she&#xD;
        received Exparel injection for the entire length of the study (which is 28 days after&#xD;
        surgery).&#xD;
  &#xD;
        The rounding team will evaluate the patient for signs of complications (based on the&#xD;
        Clavien-Dindo grading system; figure 1) and ask the patients their minimum and maximum pain&#xD;
        score (reported as 0-10 verbal numerical rating scale with 10 being worst pain) in the first&#xD;
        72 hours. The nurse will also assess patient's pain with the Visual Analogue Score (VAS;&#xD;
        Figure 1). If VAS is &gt;3 after the non-narcotic medications have been given, oral or&#xD;
        intravenous narcotic medication will be administered. If patient is discharged before 72&#xD;
        hours, the team will call the patient at 48 and 72 hours to assess pain score. The maximal&#xD;
        pain score value for the time period 0-72 hours will be chosen as the maximal pain during&#xD;
        that time period.&#xD;
  &#xD;
        Discharge criteria include pain &lt;4/10, independence of intravenous analgesia, and being&#xD;
        medically stable for discharge. If patients are waiting for placement, the time of discharge&#xD;
        for the purpose of the study will be the day they have met such criterion as opposed to the&#xD;
        day of actual discharge, as this can vary depending on patient placement.&#xD;
  &#xD;
        The nurses taking care of the study patients will fill a specific form (attachment 1) every&#xD;
        time a narcotic medication will be administered, specifying the pain score at the time of the&#xD;
        administration and the location of the pain. The filled form will be handled to the rounding&#xD;
        team on a daily basis.&#xD;
  &#xD;
        The amount of postoperative narcotic use will be calculated in morphine equivalent. Inpatient&#xD;
        narcotic use will be extrapolated from the patient's chart and the nursing forms. Outpatient&#xD;
        narcotic use will be based on the narcotic prescription(s) filled by the patient. A urine&#xD;
        drug screen will be obtained at 14 days (at the time of the first postoperative clinic visit)&#xD;
        and at 28 days, but only in those patients who did not fill the narcotic prescription, to&#xD;
        make sure those patients did not obtain narcotics from other sources.&#xD;
  &#xD;
        Patient quality of recovery and satisfaction will be assessed with a patient survey&#xD;
        administered the day of discharge and at 30 days (see attachment 2). For quality of recovery&#xD;
        measurement, we used the validated and psychometrically evaluated questionnaire QoR-15 from&#xD;
        Stark and colleagues, a short form of the comprehensive 40-item questionnaire QoR-40. (6,7).&#xD;
  &#xD;
        At the time of the signature of the consent, the patients will receive educational materials&#xD;
        regarding use of narcotics and associated side effects (from the Center of Disease and&#xD;
        Prevention Control, Opioid Factsheet for Patients [cdc.gov]), covering the main points showed&#xD;
        in the attachment 3.(8) The educational material on narcotic use will be re-discussed with&#xD;
        the patients at the time of the discharge.&#xD;
  &#xD;
        The research coordinator team will be in charge of randomizing patients and communicating the&#xD;
        result to pharmacy. Based on the results, pharmacy will send the solution (either Exparel or&#xD;
        &quot;modified&quot; normal saline to resemble Exparel) to inject during the ultrasound guided&#xD;
        ilio-inguinal block. As mentioned above, patient, surgeon, and rounding team will be blinded&#xD;
        (triple blind, randomized study). Demographics, pre-operative cardiovascular risk factors,&#xD;
        procedural details, intra- and post-operative complications, hospital stay, patient recovery&#xD;
        satisfaction, intraoperative narcotic use (in morphine equivalent), postoperative narcotic&#xD;
        use (in morphine equivalent) at 12, 24, 48, and 72hr, total postoperative narcotic use (in&#xD;
        morphine equivalent) at 28 days ilio-inguinal block will be recorded in a redcap database.&#xD;
  &#xD;
        Treatment technique:&#xD;
  &#xD;
        The patient will be brought to the operative room and general anesthesia initiated in supine&#xD;
        position. After the patient will be prepped and draped in standard sterile fashion, the new&#xD;
        intervention, for which this study is designed, will include identifying the transversus&#xD;
        abdominis muscle with ultrasound guidance, few centimeters above the anterior superior iliac&#xD;
        spine, in the surgical side. Using sterile technique, an 20g Nerve block needle will be&#xD;
        inserted and advanced under ultrasound guidance until it is below the fascial covering of the&#xD;
        transversus abdominis muscle layer. Gentle aspiration for air, or blood will be performed and&#xD;
        either 30 cc mix of 1 vial of Liposomal bupivacaine/1 vial of 0.25% bupivacaine/100 cc of&#xD;
        saline or 30 mL of normal saline will be injected under ultrasound guidance. For each 5cc of&#xD;
        local anesthetic injected, aspiration will be performed. Upon completion of the injection,&#xD;
        the needle will then be removed. In the control group, the same technique will be utilized&#xD;
        but normal saline alone will be injected instead. The solution of normal saline with be&#xD;
        opacified by pharmacy to resemble Exparel solution and to keep the surgeon blinded. Both the&#xD;
        patient and the surgeon will be not aware of the solution injected.&#xD;
  &#xD;
        During the procedure, after the plan of dissection is completed and the target vessels&#xD;
        exposed and controlled, the edges of the wound(s) will be injected with the remaining mix of&#xD;
        Liposomal bupivacaine/bupivacaine/saline (or normal saline alone in the control group). The&#xD;
        revascularization will continue as per standard of care. At the end of the revascularization,&#xD;
        the wound(s) will be closed in multiple layers. Once the procedure is completed, the patient&#xD;
        will be sent to the recovery room and eventually to the hospital room.&#xD;
  &#xD;
        Recruitment:&#xD;
  &#xD;
        Consenting Procedure:&#xD;
  &#xD;
        Before any procedure is performed, informed consent will be obtained. A single informed&#xD;
        consent form that describes both the study procedures will be discussed with the patient&#xD;
        including pros and cons of injection of Exparel or normal saline, side effects and potential&#xD;
        complications of these medications.&#xD;
  &#xD;
        Patients need to agree to perform a urine drug test at 14 and 28 days if required (see&#xD;
        below), filled the survey questionnaire for patient's recovery satisfaction, provide the&#xD;
        highest pain score.&#xD;
  &#xD;
        The attending provider or the team nurse practitioner, resident or research coordinator will&#xD;
        obtain the consent. These individuals would have basic medical education and degree necessary&#xD;
        for proper explanation of the details of the study and the medical implications involved.&#xD;
        Patients will be reconsented if needed after any major change in clinical condition or&#xD;
        adverse events reporting. A copy of the signed informed consent will be kept in the medical&#xD;
        record and a digital copy maintained on a password protected secure file.&#xD;
  &#xD;
        Patients will be randomized following consent and subsequently evaluated with intention to&#xD;
        treat. Randomization will be performed by the research coordinator. During the inpatient&#xD;
        hospital phase of their recovery patients will be assessed by the rounding team for pain&#xD;
        score and postoperative complications. Following discharge patients will be seen in clinic at&#xD;
        14 days for wound check, pain control, patient's recovery satisfaction and narcotic use. If&#xD;
        no narcotic prescription has been filled until then, a urine drug test will be administered&#xD;
        to make sure the patient did not take narcotic medication from other sources. At 28 days, a&#xD;
        clinic follow up will be performed to check wound(s), pain control, recovery satisfaction and&#xD;
        narcotic use. If no narcotic prescription has been filled, a urine drug test will be&#xD;
        administered to make sure the patient did not take narcotic medication from other sources.&#xD;
  &#xD;
        Enrollment, Baseline, and/or Randomization Enrollment Enrollment can occur at any time&#xD;
        between preoperative clinic visit and the day of surgery. A patient is enrolled once passed&#xD;
        inclusion criteria, study procedure explained to them by a qualified practitioner and have&#xD;
        signed informed consent. Enrollment date is the day of signing the consent form. That would&#xD;
        be the same day randomization will be done.&#xD;
  &#xD;
        Once patients are enrolled and consented, they will be registered in the trial.&#xD;
  &#xD;
        Prior to accepting the registration/randomization, the registration/randomization application&#xD;
        will verify the following:&#xD;
  &#xD;
          -  IRB approval at the registering institution&#xD;
  &#xD;
          -  Patient eligibility&#xD;
  &#xD;
          -  Existence of a signed consent form&#xD;
  &#xD;
          -  Existence of a signed authorization for use and disclosure of protected health&#xD;
             information&#xD;
  &#xD;
        A patient is deemed ineligible if after registration, it is determined that at the time of&#xD;
        registration, the patient did not satisfy each and every eligibility criteria for study&#xD;
        entry. The patient may continue treatment off-protocol at the discretion of the physician as&#xD;
        long as there are no safety concerns, and the patient was properly registered. The patient&#xD;
        will go off study.&#xD;
  &#xD;
        If the patient received treatment, all data up until the point of confirmation of&#xD;
        ineligibility must be submitted. If the patient never received treatment, on-study material&#xD;
        must be submitted.&#xD;
  &#xD;
        A patient is deemed a major violation, if protocol requirements regarding treatment are&#xD;
        severely violated that evaluability for primary end point is questionable. All data up until&#xD;
        the point of confirmation of a major violation must be submitted. The patient will go off&#xD;
        study. The patient may continue treatment off-protocol at the discretion of the physician as&#xD;
        long as there are no safety concerns, and the patient was properly registered.&#xD;
  &#xD;
        A patient is deemed a cancel if he/she is removed from the study for any reason before any&#xD;
        study treatment is given. On-study material and the End of Active Treatment/Cancel&#xD;
        Notification Form must be submitted. No further data submission is necessary.&#xD;
  &#xD;
        Baseline Assessments Baseline assessment will include review of medical history, physical&#xD;
        examination by treatment team, review of medications, and labs by the individual obtaining&#xD;
        consent.&#xD;
  &#xD;
        Randomization Randomization will be done once patients are enrolled. Upon patient discharge&#xD;
        from the hospital, initiation of study intervention will occur. After the patient has been&#xD;
        registered into the study, Randomization will be performed by an inpatient pharmacist at Mayo&#xD;
        Clinic Eau Claire using an online randomizer, the patient will be assigned to one of the&#xD;
        following treatment groups- Exparel or control with normal saline.&#xD;
  &#xD;
        Follow-up Visits Patients will be seen for an in-person follow-up visit between POD 14 and&#xD;
        28. Treatment administration form, vitals, and adverse events will be reviewed at follow-up&#xD;
        appointment. For patients who did not fill the narcotic prescription, a urine drug test will&#xD;
        be administered at 14 and/or 28 days to make sure those patients did not take narcotic&#xD;
        medication from other sources.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</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>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative use of narcotics at 12 hours</measure>
      <time_frame>12 hours after injection</time_frame>
      <description>Measured in morphine equivalent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative use of narcotics at 24 hours</measure>
      <time_frame>24 hours after injection</time_frame>
      <description>Measured in morphine equivalent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative use of narcotics at 48 hours</measure>
      <time_frame>48 hours after injection</time_frame>
      <description>Measured in morphine equivalent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative use of narcotics at 72 hours</measure>
      <time_frame>72 hours after injection</time_frame>
      <description>Measured in morphine equivalent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative use of narcotics at 30 days</measure>
      <time_frame>30 days after injection</time_frame>
      <description>Measured in morphine equivalent</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative quality of recovery at 14 days</measure>
      <time_frame>14 days after injection</time_frame>
      <description>Measured using the self-reported quality of recovery score (QoR)-15. The 15-item questionnaire patient satisfaction survey over the last 24 hours on 11 point Likert scale for positive items, 0 = &quot;none of the time&quot; to 10 = &quot;all of the time&quot;; for negative items the scoring was reversed. Total score range 0 to 150, with higher scores indicating better quality of recovery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative quality of recovery at 28 days</measure>
      <time_frame>28 days after injection</time_frame>
      <description>Measured using the self-reported quality of recovery score (QoR)-15. The 15-item questionnaire patient satisfaction survey over the last 24 hours on 11 point Likert scale for positive items, 0 = &quot;none of the time&quot; to 10 = &quot;all of the time&quot;; for negative items the scoring was reversed. Total score range 0 to 150, with higher scores indicating better quality of recovery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative use of narcotics</measure>
      <time_frame>During surgery approximately 2 to 6 hours</time_frame>
      <description>Measured in morphine equivalent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Length of Stay</measure>
      <time_frame>28 days</time_frame>
      <description>Total number of hours subjects were admitted to the hospital</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Peripheral Arterial Disease</condition>
    <arm_group>
      <arm_group_label>Liposomal Bupivacaine Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive an injection of liposomal bupivacaine during clinically indicated lower extremity revascularization surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Subjects will receive an injection of placebo during clinically indicated lower extremity revascularization surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine liposome</intervention_name>
      <description>Injection into pelvic area and into the edges of wound at the end of the procedure.</description>
      <arm_group_label>Liposomal Bupivacaine Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Looks exactly like the study drug, but contains no active ingredients. Injection into pelvic area and into the edges of wound at the end of the procedure .</description>
      <arm_group_label>Placebo Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Those who present for elective lower extremity revascularization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-English speaking.&#xD;
  &#xD;
            -  Chronic pain.&#xD;
  &#xD;
            -  On opioids greater than 1 weeks.&#xD;
  &#xD;
            -  Allergy to local anesthetics.&#xD;
  &#xD;
            -  Use of spinal or epidural for surgery.&#xD;
  &#xD;
            -  Lack of patient cooperation.&#xD;
  &#xD;
            -  Lontraindication to regional anesthesia.&#xD;
  &#xD;
            -  Vulnerable individuals.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tiziano Tallarita, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joshua Druckrey</last_name>
      <phone>715-838-5831</phone>
      <email>druckrey.joshua@mayo.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mayo Clinic Health System - Eau Claire</name>
        <address>
          <city>Eau Claire</city>
          <state>Wisconsin</state>
          <zip>54703</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Tiziano Tallarita</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>peripheral arterial disease</keyword>
    <keyword>postoperative pain control</keyword>
    <keyword>narcotic abuse</keyword>
    <keyword>Ilio-inguinal block</keyword>
    <keyword>regional anesthesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Arterial Disease</mesh_term>
      <mesh_term>Peripheral Vascular Diseases</mesh_term>
    </condition_browse>
    <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>
    </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/NCT05992896
  org study id: 23-003451
  nct id: NCT05992896
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this research is to find out if using liposomal bupivacaine solution
        (bupivacaine liposome) injections during lower extremity revascularization surgery will lower
        the amount of narcotic drugs used during and following the procedure.
  This will be a single site, triple blinded, controlled randomized trial assessing potential
        reduction in narcotic use in patients undergoing lower extremity revascularization, when
        loco-regional anesthesia with Exparel solution is performed, compared to normal saline
        injection. Loco-regional anesthesia for lower extremity revascularization will include an
        ultrasound guided ilio-inguinal block with Exparel solution and local injection in the
        wound(s) edges of more Exparel solution. The control group will receive injection of normal
        saline instead. Lower extremity revascularizations will include femoral endarterectomy with
        patching ± antegrade or retrograde endovascular intervention (one or more combination of
        stenting, atherectomy, balloon angioplasty) or bypass (femoral popliteal or femoral tibial
        bypasses with vein or prosthetic graft).
  
        The study will be conducted at Mayo Clinic Health System in Eau Claire only (single site).
  
        The enrolled patients will be medicated in pre- and intra-operative phases by the anesthesia
        team in a standardized fashion, based on the protocol in attachment 4.
  
        Patient, surgeon, and the team assessing the patient postoperatively will be blinded (triple
        blinded). Normal saline will be opacified by the pharmacy to keep the surgeon unaware of what
        he/she is injecting. As per Mayo policy, all patients will receive the surgical bill at least
        30 days after surgery. This time frame will allow the patient to remain blinded if he/she
        received Exparel injection for the entire length of the study (which is 28 days after
        surgery).
  
        The rounding team will evaluate the patient for signs of complications (based on the
        Clavien-Dindo grading system; figure 1) and ask the patients their minimum and maximum pain
        score (reported as 0-10 verbal numerical rating scale with 10 being worst pain) in the first
        72 hours. The nurse will also assess patient's pain with the Visual Analogue Score (VAS;
        Figure 1). If VAS is >3 after the non-narcotic medications have been given, oral or
        intravenous narcotic medication will be administered. If patient is discharged before 72
        hours, the team will call the patient at 48 and 72 hours to assess pain score. The maximal
        pain score value for the time period 0-72 hours will be chosen as the maximal pain during
        that time period.
  
        Discharge criteria include pain <4/10, independence of intravenous analgesia, and being
        medically stable for discharge. If patients are waiting for placement, the time of discharge
        for the purpose of the study will be the day they have met such criterion as opposed to the
        day of actual discharge, as this can vary depending on patient placement.
  
        The nurses taking care of the study patients will fill a specific form (attachment 1) every
        time a narcotic medication will be administered, specifying the pain score at the time of the
        administration and the location of the pain. The filled form will be handled to the rounding
        team on a daily basis.
  
        The amount of postoperative narcotic use will be calculated in morphine equivalent. Inpatient
        narcotic use will be extrapolated from the patient's chart and the nursing forms. Outpatient
        narcotic use will be based on the narcotic prescription(s) filled by the patient. A urine
        drug screen will be obtained at 14 days (at the time of the first postoperative clinic visit)
        and at 28 days, but only in those patients who did not fill the narcotic prescription, to
        make sure those patients did not obtain narcotics from other sources.
  
        Patient quality of recovery and satisfaction will be assessed with a patient survey
        administered the day of discharge and at 30 days (see attachment 2). For quality of recovery
        measurement, we used the validated and psychometrically evaluated questionnaire QoR-15 from
        Stark and colleagues, a short form of the comprehensive 40-item questionnaire QoR-40. (6,7).
  
        At the time of the signature of the consent, the patients will receive educational materials
        regarding use of narcotics and associated side effects (from the Center of Disease and
        Prevention Control, Opioid Factsheet for Patients [cdc.gov]), covering the main points showed
        in the attachment 3.(8) The educational material on narcotic use will be re-discussed with
        the patients at the time of the discharge.
  
        The research coordinator team will be in charge of randomizing patients and communicating the
        result to pharmacy. Based on the results, pharmacy will send the solution (either Exparel or
        "modified" normal saline to resemble Exparel) to inject during the ultrasound guided
        ilio-inguinal block. As mentioned above, patient, surgeon, and rounding team will be blinded
        (triple blind, randomized study). Demographics, pre-operative cardiovascular risk factors,
        procedural details, intra- and post-operative complications, hospital stay, patient recovery
        satisfaction, intraoperative narcotic use (in morphine equivalent), postoperative narcotic
        use (in morphine equivalent) at 12, 24, 48, and 72hr, total postoperative narcotic use (in
        morphine equivalent) at 28 days ilio-inguinal block will be recorded in a redcap database.
  
        Treatment technique:
  
        The patient will be brought to the operative room and general anesthesia initiated in supine
        position. After the patient will be prepped and draped in standard sterile fashion, the new
        intervention, for which this study is designed, will include identifying the transversus
        abdominis muscle with ultrasound guidance, few centimeters above the anterior superior iliac
        spine, in the surgical side. Using sterile technique, an 20g Nerve block needle will be
        inserted and advanced under ultrasound guidance until it is below the fascial covering of the
        transversus abdominis muscle layer. Gentle aspiration for air, or blood will be performed and
        either 30 cc mix of 1 vial of Liposomal bupivacaine/1 vial of 0.25% bupivacaine/100 cc of
        saline or 30 mL of normal saline will be injected under ultrasound guidance. For each 5cc of
        local anesthetic injected, aspiration will be performed. Upon completion of the injection,
        the needle will then be removed. In the control group, the same technique will be utilized
        but normal saline alone will be injected instead. The solution of normal saline with be
        opacified by pharmacy to resemble Exparel solution and to keep the surgeon blinded. Both the
        patient and the surgeon will be not aware of the solution injected.
  
        During the procedure, after the plan of dissection is completed and the target vessels
        exposed and controlled, the edges of the wound(s) will be injected with the remaining mix of
        Liposomal bupivacaine/bupivacaine/saline (or normal saline alone in the control group). The
        revascularization will continue as per standard of care. At the end of the revascularization,
        the wound(s) will be closed in multiple layers. Once the procedure is completed, the patient
        will be sent to the recovery room and eventually to the hospital room.
  
        Recruitment:
  
        Consenting Procedure:
  
        Before any procedure is performed, informed consent will be obtained. A single informed
        consent form that describes both the study procedures will be discussed with the patient
        including pros and cons of injection of Exparel or normal saline, side effects and potential
        complications of these medications.
  
        Patients need to agree to perform a urine drug test at 14 and 28 days if required (see
        below), filled the survey questionnaire for patient's recovery satisfaction, provide the
        highest pain score.
  
        The attending provider or the team nurse practitioner, resident or research coordinator will
        obtain the consent. These individuals would have basic medical education and degree necessary
        for proper explanation of the details of the study and the medical implications involved.
        Patients will be reconsented if needed after any major change in clinical condition or
        adverse events reporting. A copy of the signed informed consent will be kept in the medical
        record and a digital copy maintained on a password protected secure file.
  
        Patients will be randomized following consent and subsequently evaluated with intention to
        treat. Randomization will be performed by the research coordinator. During the inpatient
        hospital phase of their recovery patients will be assessed by the rounding team for pain
        score and postoperative complications. Following discharge patients will be seen in clinic at
        14 days for wound check, pain control, patient's recovery satisfaction and narcotic use. If
        no narcotic prescription has been filled until then, a urine drug test will be administered
        to make sure the patient did not take narcotic medication from other sources. At 28 days, a
        clinic follow up will be performed to check wound(s), pain control, recovery satisfaction and
        narcotic use. If no narcotic prescription has been filled, a urine drug test will be
        administered to make sure the patient did not take narcotic medication from other sources.
  
        Enrollment, Baseline, and/or Randomization Enrollment Enrollment can occur at any time
        between preoperative clinic visit and the day of surgery. A patient is enrolled once passed
        inclusion criteria, study procedure explained to them by a qualified practitioner and have
        signed informed consent. Enrollment date is the day of signing the consent form. That would
        be the same day randomization will be done.
  
        Once patients are enrolled and consented, they will be registered in the trial.
  
        Prior to accepting the registration/randomization, the registration/randomization application
        will verify the following:
  
          -  IRB approval at the registering institution
  
          -  Patient eligibility
  
          -  Existence of a signed consent form
  
          -  Existence of a signed authorization for use and disclosure of protected health
             information
  
        A patient is deemed ineligible if after registration, it is determined that at the time of
        registration, the patient did not satisfy each and every eligibility criteria for study
        entry. The patient may continue treatment off-protocol at the discretion of the physician as
        long as there are no safety concerns, and the patient was properly registered. The patient
        will go off study.
  
        If the patient received treatment, all data up until the point of confirmation of
        ineligibility must be submitted. If the patient never received treatment, on-study material
        must be submitted.
  
        A patient is deemed a major violation, if protocol requirements regarding treatment are
        severely violated that evaluability for primary end point is questionable. All data up until
        the point of confirmation of a major violation must be submitted. The patient will go off
        study. The patient may continue treatment off-protocol at the discretion of the physician as
        long as there are no safety concerns, and the patient was properly registered.
  
        A patient is deemed a cancel if he/she is removed from the study for any reason before any
        study treatment is given. On-study material and the End of Active Treatment/Cancel
        Notification Form must be submitted. No further data submission is necessary.
  
        Baseline Assessments Baseline assessment will include review of medical history, physical
        examination by treatment team, review of medications, and labs by the individual obtaining
        consent.
  
        Randomization Randomization will be done once patients are enrolled. Upon patient discharge
        from the hospital, initiation of study intervention will occur. After the patient has been
        registered into the study, Randomization will be performed by an inpatient pharmacist at Mayo
        Clinic Eau Claire using an online randomizer, the patient will be assigned to one of the
        following treatment groups- Exparel or control with normal saline.
  
        Follow-up Visits Patients will be seen for an in-person follow-up visit between POD 14 and
        28. Treatment administration form, vitals, and adverse events will be reviewed at follow-up
        appointment. For patients who did not fill the narcotic prescription, a urine drug test will
        be administered at 14 and/or 28 days to make sure those patients did not take narcotic
        medication from other sources.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Postoperative use of narcotics at 12 hours
  time frame: 12 hours after injection
  description: Measured in morphine equivalent
  measure: Postoperative use of narcotics at 24 hours
  time frame: 24 hours after injection
  description: Measured in morphine equivalent
  measure: Postoperative use of narcotics at 48 hours
  time frame: 48 hours after injection
  description: Measured in morphine equivalent
  measure: Postoperative use of narcotics at 72 hours
  time frame: 72 hours after injection
  description: Measured in morphine equivalent
  measure: Postoperative use of narcotics at 30 days
  time frame: 30 days after injection
  description: Measured in morphine equivalent
  measure: Postoperative quality of recovery at 14 days
  time frame: 14 days after injection
  description: Measured using the self-reported quality of recovery score (QoR)-15. The 15-item questionnaire patient satisfaction survey over the last 24 hours on 11 point Likert scale for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items the scoring was reversed. Total score range 0 to 150, with higher scores indicating better quality of recovery.
  measure: Postoperative quality of recovery at 28 days
  time frame: 28 days after injection
  description: Measured using the self-reported quality of recovery score (QoR)-15. The 15-item questionnaire patient satisfaction survey over the last 24 hours on 11 point Likert scale for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items the scoring was reversed. Total score range 0 to 150, with higher scores indicating better quality of recovery.
  measure: Intraoperative use of narcotics
  time frame: During surgery approximately 2 to 6 hours
  description: Measured in morphine equivalent
  measure: Hospital Length of Stay
  time frame: 28 days
  description: Total number of hours subjects were admitted to the hospital
  arm group label: Liposomal Bupivacaine Group
  arm group type: Experimental
  description: Subjects will receive an injection of liposomal bupivacaine during clinically indicated lower extremity revascularization surgery.
  arm group label: Placebo Group
  arm group type: Placebo Comparator
  description: Subjects will receive an injection of placebo during clinically indicated lower extremity revascularization surgery.
  intervention type: Drug
  intervention name: Bupivacaine liposome
  description: Injection into pelvic area and into the edges of wound at the end of the procedure.
  arm group label: Liposomal Bupivacaine Group
  intervention type: Drug
  intervention name: Placebo
  description: Looks exactly like the study drug, but contains no active ingredients. Injection into pelvic area and into the edges of wound at the end of the procedure .
  arm group label: Placebo Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tiziano Tallarita, MD
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Joshua Druckrey
  phone: 715-838-5831
  email: druckrey.joshua@mayo.edu
  facility: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Tiziano Tallarita
  investigator title: Principal Investigator
  mesh term: Peripheral Arterial Disease
  mesh term: Peripheral Vascular Diseases
  mesh term: Bupivacaine
  sharing ipd: No