Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL
Condition: Postoperative Pain Management
MeSH terms: Pain, Postoperative
Intervention: Exparel; 0.5% Bupivacaine HCl
Intervention description: EXPAREL 4mg/kg (maximum 266 mg); Bupivacaine HCl 2mg/kg
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric

Summary:

      Primary Objective: To evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects
      aged 6 to less than 17 years undergoing various types of surgeries.

      Secondary Objective: To evaluate the safety of EXPAREL in pediatric subjects aged 6 to less
      than 17 years undergoing various types of surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects whose parent(s) or guardian(s) has/have signed and dated the ICF for the
             subject to participate in the study, and subjects who have provided written assent to
             participate in the study (if capable).

          2. American Society of Anesthesiologists (ASA) Class 1-3.

          3. Male or female subjects 6 to less than 17 years of age on the day of surgery.

          4. Body mass index (BMI) at screening within the 5th to 95th percentile for age and sex
             (see Appendix 5).

          5. A negative pregnancy test for female subjects of childbearing potential must be
             available prior to the start of surgery. The pregnancy test must be conducted in the
             preoperative holding area according to the study site's standard of care.

          6. Subjects and their parent(s)/guardian(s) must be able to speak, read, and understand
             the language of the ICF and any instruments used for collecting subject-reported
             outcomes to enable accurate and appropriate responses to study assessments, and
             provide informed consent/assent.

          7. Subjects must be able to adhere to the study visit schedule and complete all study
             assessments.

        Exclusion Criteria:

          1. Currently pregnant, breastfeeding, or planning to become pregnant during the study or
             within 1 month after study drug administration.

          2. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
             or to opioid medication.

          3. Contraindication to bupivacaine HCl or other amide-type local anesthetics or to opioid
             medication.

          4. Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug
             administration.

          5. Subjects with coagulopathies or immunodeficiency disorders.

          6. History of, suspected, or known addiction to or abuse of drugs or alcohol within the
             past 2 years.

          7. Clinically significant medical or psychiatric disease that, in the opinion of the
             investigator, indicates an increased vulnerability to study drugs and/or procedures.

          8. Administration of an investigational drug within 30 days or 5 elimination half-lives
             of such investigational drug, whichever is longer, prior to study drug administration,
             or planned administration of another investigational product or procedure during the
             subject's participation in this study.

             In addition, the subject will be ineligible to receive study drug if he or she meets
             the following criterion during surgery:

          9. Any clinically significant event or condition uncovered during the surgery (e.g.,
             excessive bleeding, acute sepsis) that might render the subject medically unstable or
             complicate the subject's postsurgical course.