<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/NCT02985762</url>
  </required_header>
  <id_info>
    <org_study_id>402-C-117</org_study_id>
    <nct_id>NCT02985762</nct_id>
  </id_info>
  <brief_title>PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery</brief_title>
  <official_title>A Phase 1, Open-Label Study to Evaluate the Safety and Pharmacokinetics of Local Administration of EXPAREL When Administered for Prolonged Postsurgical Analgesia in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pacira Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pacira Pharmaceuticals, Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to characterize the pharmacokinetic (PK) profile of&#xD;
      EXPAREL when administered via local wound infiltration to subjects undergoing open spinal&#xD;
      fusion or reconstructive surgery.&#xD;
&#xD;
      The secondary objectives of this study are to assess the safety, tolerability, and efficacy&#xD;
      of EXPAREL in this surgical model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, multi-center, open-label study designed to evaluate the safety and&#xD;
      pharmacokinetics of EXPAREL when administered via local wound infiltration to subjects&#xD;
      undergoing open cervical or thoracic spinal fusion or reconstructive surgery.&#xD;
&#xD;
      Fifteen subjects are planned for enrollment. Eligible subjects, whose surgical incision must&#xD;
      be at least 8 cm in length, will receive a single dose of EXPAREL (266 mg/20 mL) expanded in&#xD;
      volume with 20-60 mL normal saline, depending on the size of the incision. Incision will be&#xD;
      performed using a posterior surgical approach.&#xD;
&#xD;
      Administration Technique:&#xD;
&#xD;
      Study drug should be injected in the prescribed locations based on the areas of highest nerve&#xD;
      density. Study drug will be administered using syringes with 22-gauge needles prior to wound&#xD;
      closure. The Investigator must document the size of the incision. Each infiltration site&#xD;
      should be spaced 1.0-1.5 cm apart and should deliver approximately 1-1.5 mL into both deep&#xD;
      and superficial areas (para-spinous fascia, muscle, and subcutaneous layers). As each&#xD;
      incision will have three layers of infiltration, the total volume to be infiltrated can range&#xD;
      from 40-80 mL (please refer to below specifics on how to determine total volume of&#xD;
      expansion). Following infiltration, the tissue should visibly expand with minimal leakage.&#xD;
&#xD;
      Total Volume of Expansion:&#xD;
&#xD;
      The Investigator must document the total volume used for each surgery.&#xD;
&#xD;
        -  EXPAREL (20 mL) + normal saline (20-60 mL based on the incision size) = total volume.&#xD;
&#xD;
        -  For example: If the infiltration sites are 1.5 cm apart, then a 10 cm incision would be&#xD;
           10 × 2 sides × 3 layers = 60 cm. If there is 1 mL infiltrated every 1.5 cm, the total&#xD;
           volume would be 40 mL.&#xD;
&#xD;
      Screening:&#xD;
&#xD;
      Subjects will be screened within 30 days prior to study drug administration. During the&#xD;
      screening visit, which must take place at least 1 day prior to surgery, subjects will be&#xD;
      assessed for past or present neurologic, cardiac, and general medical conditions that in the&#xD;
      opinion of the Investigator would preclude them from study participation. After the informed&#xD;
      consent form (ICF) is signed, a medical/surgical history, physical examination, vital signs,&#xD;
      12-lead electrocardiogram (ECG), neurological assessment, alcohol breath test, urine drug&#xD;
      screen, and urine pregnancy test for women of childbearing potential will be conducted.&#xD;
&#xD;
      Trained and qualified Investigators will use their usual standard of care surgical technique&#xD;
      to perform the surgery. The use of fentanyl or analogues will be permitted (during surgery&#xD;
      only). Intraoperative administration of other opioids or any other analgesic, local&#xD;
      anesthetics, or anti-inflammatory agents will be prohibited unless needed to treat an adverse&#xD;
      event (AE).&#xD;
&#xD;
      Subjects must remain in the hospital for at least 72 hours after surgery in order to undergo&#xD;
      postsurgical assessments. In addition, subjects must return for the 84 hour and 96 hour study&#xD;
      assessments.&#xD;
&#xD;
      Day 7 Follow-Up Visit:&#xD;
&#xD;
      All subjects will return on Day 7 for a follow-up visit, which will include vital sign&#xD;
      measurements, 12-lead ECG, neurological assessment, blood sample collection for PK analysis,&#xD;
      and an AE assessment.&#xD;
&#xD;
      Postsurgical Safety Assessments:&#xD;
&#xD;
      This will include a cardiac assessment (i.e., 12-lead ECG), neurological assessment, and&#xD;
      vital signs. Adverse events will be recorded from the time the ICF is signed through Day 30.&#xD;
      If a cardiac or neurological AE of special interest or SAE occurs during the study, an&#xD;
      unscheduled PK blood sample must be collected. In addition, a 12-lead ECG, vital signs, and&#xD;
      any appropriate clinical laboratory tests must be conducted. Cardiac AEs of special interest&#xD;
      include chest pain (angina, myocardial infarction), abnormal/irregular heart rate&#xD;
      (bradycardia, tachycardia, extrasystoles), and shortness of breath requiring intervention.&#xD;
      Neurologic AEs of special interest include altered mental status/altered sensorium, rigidity,&#xD;
      dysarthria, seizure, tremors, metallic taste, tinnitus, perioral numbness, visual&#xD;
      disturbance, and severe or worsening dizziness. Additionally, the following events are of&#xD;
      special interest if they persist or occur beyond 72-hours postdose: dizziness, hyperesthesia,&#xD;
      muscular twitching, and tingling/paresthesia.&#xD;
&#xD;
      Postsurgical Efficacy Assessments&#xD;
&#xD;
      Will include pain intensity scores using a 10 cm visual analog scale (VAS) and use of&#xD;
      supplemental opioid rescue medication.&#xD;
&#xD;
      Pharmacokinetic Assessment:&#xD;
&#xD;
      Blood samples for PK analysis will be obtained predose (on Day 1 prior to study drug&#xD;
      administration); 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours&#xD;
      after the beginning of study drug administration; and on Day 7.&#xD;
&#xD;
      Number of Planned Patients for enrollment is 15 adult subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The area under the plasma concentration-versus-time curve from the time of administration extrapolated to infinity. The residual area from the time of the last quantifiable concentration (Ctlast) to infinity is to be calculated using the approximation</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The VAS pain intensity scores at each assessed timepoint</measure>
    <time_frame>72 hours</time_frame>
    <description>Pain intensity scores using the VAS at predose (on Day 1 prior to study drug administration); upon arrival at the post-anesthesia care unit (PACU); at 4, 8, 12, 24, 36, 48, 60, and 72 hours after the beginning of study drug administration; immediately prior to each administration of rescue pain medication; and just prior to hospital discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total inpatient postsurgical opioid consumption (in mg) through 72 hours or hospital discharge</measure>
    <time_frame>72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to first opioid rescue through 72 hours or hospital discharge</measure>
    <time_frame>72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The area under the plasma concentration-versus-time curve from the time of administration to the time of the last quantifiable concentration calculated using the log-linear trapezoidal rule</measure>
    <time_frame>7 days</time_frame>
    <description>Pharmacokinetic parameters will be estimated from plasma bupivacaine measurements using non-compartmental analysis, based on the sampling schedule at predose (on Day 1 prior to study drug administration); 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after the beginning of study drug administration; and on Day 7</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The maximum observed plasma concentration obtained directly from the experimental data without interpolation. Overall, early Cmax (occurring within 2 hours postdose) and late Cmax (occurring after 2 hours postdose) will be presented</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The time to maximum plasma concentration (Cmax). Overall, early, and late Tmax will be presented</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The apparent terminal elimination rate constant determined by log-linear regression of the terminal log-linear segment of the plasma concentration-versus-time curve</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The apparent terminal elimination half-life calculated as 0.693/λz</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of TEAEs through Day 30</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of neurological assessments (proportion of subjects who are oriented and proportion of subjects who have any of the neurological events</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in ECG data closest to the median Tmax</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator assessment of the ECG (normal, abnormal - not clinically significant, abnormal - clinically significant)</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in vital signs at each assessed timepoint</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Spinal Fusion</condition>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>EXPAREL 266 mg/20 mL</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Eligible subjects, whose surgical incision must be at least 8 cm in length, will receive a single dose of EXPAREL (266 mg/20 mL) expanded in volume with 20-60 mL normal saline, depending on the size of the incision</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EXPAREL</intervention_name>
    <arm_group_label>EXPAREL 266 mg/20 mL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females ≥18 years of age.&#xD;
&#xD;
          2. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.&#xD;
&#xD;
          3. Scheduled to undergo primary, ≥3 level cervical or thoracic spine fusion or&#xD;
             reconstruction under general anesthesia. The surgical incision must be at least 8 cm&#xD;
             in length.&#xD;
&#xD;
          4. Female subject must be surgically sterile; or at least 2 years postmenopausal; or have&#xD;
             a monogamous partner who is surgically sterile; or practicing double-barrier&#xD;
             contraception; or practicing abstinence (must agree to use double-barrier&#xD;
             contraception in the event of sexual activity); or using an insertable, injectable,&#xD;
             transdermal, or combination oral contraceptive approved by the FDA for greater than 2&#xD;
             months prior to screening and commit to the use of an acceptable form of birth control&#xD;
             for the duration of the study and for 30 days after completion of the study.&#xD;
&#xD;
          5. Able to provide informed consent, adhere to the study schedule, and complete all study&#xD;
             assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics&#xD;
             or opioids.&#xD;
&#xD;
          2. Contraindication to bupivacaine.&#xD;
&#xD;
          3. Received bupivacaine or any other local anesthetic within 7 days of screening.&#xD;
&#xD;
          4. Receiving workers' compensation.&#xD;
&#xD;
          5. Currently pregnant, nursing, or planning to become pregnant during the study or within&#xD;
             1 month after study drug administration.&#xD;
&#xD;
          6. Non-structural or acute spinal conditions (e.g., cauda equina syndrome, infection,&#xD;
             tumor, fracture).&#xD;
&#xD;
          7. Planned concurrent surgical procedure.&#xD;
&#xD;
          8. Comorbidity impacting current physical function or Investigator opinion that it may&#xD;
             impact postsurgical rehabilitation.&#xD;
&#xD;
          9. Body weight &lt;50 kg (110 pounds) or a body mass index ≥45 kg/m2.&#xD;
&#xD;
         10. History of coronary or vascular stent placed within the past 3 months (may be extended&#xD;
             to 1 year if medically indicated per physician discretion).&#xD;
&#xD;
         11. Have been treated for a deep vein thrombosis, pulmonary embolism, myocardial&#xD;
             infarction, or ischemic stroke within the past 6 months (may be extended to 1 year if&#xD;
             medically indicated per physician discretion).&#xD;
&#xD;
         12. Severely impaired renal or hepatic function (e.g., serum creatinine level &gt; 2 mg/dL&#xD;
             [176.8 μmol/L], blood urea nitrogen level &gt;50 mg/dL [17.9 mmol/L], serum aspartate&#xD;
             aminotransferase [AST] level &gt;3 times the upper limit of normal [ULN], or serum&#xD;
             alanine aminotransferase [ALT] level &gt; 3 times ULN).&#xD;
&#xD;
         13. Any neurologic or psychiatric disorder that might impact postsurgical pain or&#xD;
             interfere with study assessments.&#xD;
&#xD;
         14. Malignancy in the last 2 years, per physician discretion.&#xD;
&#xD;
         15. History of misuse, abuse, or dependence on opioid analgesics, other prescription&#xD;
             drugs, illicit drugs, or alcohol.&#xD;
&#xD;
         16. Failure to pass the alcohol breath test or urine drug screen.&#xD;
&#xD;
         17. Current or historical evidence of any clinically significant disease or condition,&#xD;
             especially cardiovascular or neurological conditions that, in the opinion of the&#xD;
             Investigator, may increase the risk of surgery or complicate the subject's&#xD;
             postsurgical course.&#xD;
&#xD;
         18. Clinically significant medical or psychiatric disease that, in the opinion of the&#xD;
             Investigator, would constitute a contraindication to participation in the study, or&#xD;
             cause inability to comply with the study requirements.&#xD;
&#xD;
         19. Received any investigational drug within 30 days prior to study drug administration,&#xD;
             and/or has planned administration of another investigational product or procedure&#xD;
             during the subject's participation in this study.&#xD;
&#xD;
         20. Previous participation in an EXPAREL study.&#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>Hassan Danesi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Pacira Pharmaceuticals, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bupivacaine</keyword>
  <keyword>exparel</keyword>
  <keyword>analgesic</keyword>
  <keyword>lumbar spine</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02985762
org study id: 402-C-117
nct id: NCT02985762
lead sponsor: 
has dmc: Yes
The primary objective of this study is to characterize the pharmacokinetic (PK) profile of
      EXPAREL when administered via local wound infiltration to subjects undergoing open spinal
      fusion or reconstructive surgery.

      The secondary objectives of this study are to assess the safety, tolerability, and efficacy
      of EXPAREL in this surgical model.
This is a Phase 1, multi-center, open-label study designed to evaluate the safety and
      pharmacokinetics of EXPAREL when administered via local wound infiltration to subjects
      undergoing open cervical or thoracic spinal fusion or reconstructive surgery.

      Fifteen subjects are planned for enrollment. Eligible subjects, whose surgical incision must
      be at least 8 cm in length, will receive a single dose of EXPAREL (266 mg/20 mL) expanded in
      volume with 20-60 mL normal saline, depending on the size of the incision. Incision will be
      performed using a posterior surgical approach.

      Administration Technique:

      Study drug should be injected in the prescribed locations based on the areas of highest nerve
      density. Study drug will be administered using syringes with 22-gauge needles prior to wound
      closure. The Investigator must document the size of the incision. Each infiltration site
      should be spaced 1.0-1.5 cm apart and should deliver approximately 1-1.5 mL into both deep
      and superficial areas (para-spinous fascia, muscle, and subcutaneous layers). As each
      incision will have three layers of infiltration, the total volume to be infiltrated can range
      from 40-80 mL (please refer to below specifics on how to determine total volume of
      expansion). Following infiltration, the tissue should visibly expand with minimal leakage.

      Total Volume of Expansion:

      The Investigator must document the total volume used for each surgery.

        -  EXPAREL (20 mL) + normal saline (20-60 mL based on the incision size) = total volume.

        -  For example: If the infiltration sites are 1.5 cm apart, then a 10 cm incision would be
           10 × 2 sides × 3 layers = 60 cm. If there is 1 mL infiltrated every 1.5 cm, the total
           volume would be 40 mL.

      Screening:

      Subjects will be screened within 30 days prior to study drug administration. During the
      screening visit, which must take place at least 1 day prior to surgery, subjects will be
      assessed for past or present neurologic, cardiac, and general medical conditions that in the
      opinion of the Investigator would preclude them from study participation. After the informed
      consent form (ICF) is signed, a medical/surgical history, physical examination, vital signs,
      12-lead electrocardiogram (ECG), neurological assessment, alcohol breath test, urine drug
      screen, and urine pregnancy test for women of childbearing potential will be conducted.

      Trained and qualified Investigators will use their usual standard of care surgical technique
      to perform the surgery. The use of fentanyl or analogues will be permitted (during surgery
      only). Intraoperative administration of other opioids or any other analgesic, local
      anesthetics, or anti-inflammatory agents will be prohibited unless needed to treat an adverse
      event (AE).

      Subjects must remain in the hospital for at least 72 hours after surgery in order to undergo
      postsurgical assessments. In addition, subjects must return for the 84 hour and 96 hour study
      assessments.

      Day 7 Follow-Up Visit:

      All subjects will return on Day 7 for a follow-up visit, which will include vital sign
      measurements, 12-lead ECG, neurological assessment, blood sample collection for PK analysis,
      and an AE assessment.

      Postsurgical Safety Assessments:

      This will include a cardiac assessment (i.e., 12-lead ECG), neurological assessment, and
      vital signs. Adverse events will be recorded from the time the ICF is signed through Day 30.
      If a cardiac or neurological AE of special interest or SAE occurs during the study, an
      unscheduled PK blood sample must be collected. In addition, a 12-lead ECG, vital signs, and
      any appropriate clinical laboratory tests must be conducted. Cardiac AEs of special interest
      include chest pain (angina, myocardial infarction), abnormal/irregular heart rate
      (bradycardia, tachycardia, extrasystoles), and shortness of breath requiring intervention.
      Neurologic AEs of special interest include altered mental status/altered sensorium, rigidity,
      dysarthria, seizure, tremors, metallic taste, tinnitus, perioral numbness, visual
      disturbance, and severe or worsening dizziness. Additionally, the following events are of
      special interest if they persist or occur beyond 72-hours postdose: dizziness, hyperesthesia,
      muscular twitching, and tingling/paresthesia.

      Postsurgical Efficacy Assessments

      Will include pain intensity scores using a 10 cm visual analog scale (VAS) and use of
      supplemental opioid rescue medication.

      Pharmacokinetic Assessment:

      Blood samples for PK analysis will be obtained predose (on Day 1 prior to study drug
      administration); 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours
      after the beginning of study drug administration; and on Day 7.

      Number of Planned Patients for enrollment is 15 adult subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The area under the plasma concentration-versus-time curve from the time of administration extrapolated to infinity. The residual area from the time of the last quantifiable concentration (Ctlast) to infinity is to be calculated using the approximation
time frame: 7 days
measure: The VAS pain intensity scores at each assessed timepoint
time frame: 72 hours
description: Pain intensity scores using the VAS at predose (on Day 1 prior to study drug administration); upon arrival at the post-anesthesia care unit (PACU); at 4, 8, 12, 24, 36, 48, 60, and 72 hours after the beginning of study drug administration; immediately prior to each administration of rescue pain medication; and just prior to hospital discharge
measure: Total inpatient postsurgical opioid consumption (in mg) through 72 hours or hospital discharge
time frame: 72 hours
measure: Time to first opioid rescue through 72 hours or hospital discharge
time frame: 72 hours
measure: The area under the plasma concentration-versus-time curve from the time of administration to the time of the last quantifiable concentration calculated using the log-linear trapezoidal rule
time frame: 7 days
description: Pharmacokinetic parameters will be estimated from plasma bupivacaine measurements using non-compartmental analysis, based on the sampling schedule at predose (on Day 1 prior to study drug administration); 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after the beginning of study drug administration; and on Day 7
measure: The maximum observed plasma concentration obtained directly from the experimental data without interpolation. Overall, early Cmax (occurring within 2 hours postdose) and late Cmax (occurring after 2 hours postdose) will be presented
time frame: 7 days
measure: The time to maximum plasma concentration (Cmax). Overall, early, and late Tmax will be presented
time frame: 7 days
measure: The apparent terminal elimination rate constant determined by log-linear regression of the terminal log-linear segment of the plasma concentration-versus-time curve
time frame: 7 days
measure: The apparent terminal elimination half-life calculated as 0.693/λz
time frame: 7 days
measure: Incidence of TEAEs through Day 30
time frame: 30 days
measure: Summary of neurological assessments (proportion of subjects who are oriented and proportion of subjects who have any of the neurological events
time frame: 30 days
measure: Change from baseline in ECG data closest to the median Tmax
time frame: 30 days
measure: Investigator assessment of the ECG (normal, abnormal - not clinically significant, abnormal - clinically significant)
time frame: 30 days
measure: Change from baseline in vital signs at each assessed timepoint
time frame: 30 days
arm group label: EXPAREL 266 mg/20 mL
arm group type: Other
description: Eligible subjects, whose surgical incision must be at least 8 cm in length, will receive a single dose of EXPAREL (266 mg/20 mL) expanded in volume with 20-60 mL normal saline, depending on the size of the incision
intervention type: Drug
intervention name: EXPAREL
arm group label: EXPAREL 266 mg/20 mL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hassan Danesi, MD
role: Study Director
affiliation: Pacira Pharmaceuticals, Inc
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No