Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
Condition: Lower Extremity Surgery; Bunion; Metatarsophalangeal Fushion; Midfoot Fusion; Hindfoot Fushion; Total Ankle Arthroplasty
MeSH terms: Bunion
Intervention: Exparel; Bupivacaine Hydrochloride
Intervention description: EXPAREL (bupivacaine liposome injectable suspension); 0.25% bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, multicenter, randomized, double blinded, active controlled study in
      approximately 120 subjects undergoing lower extremity surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult male or female volunteers ages 18 or older

          2. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3

          3. Able to provide informed consent, adhere to the study schedule, and complete all study
             assessments

          4. Body Mass Index (BMI) ≥18 and ≤40 kg/m2

        Exclusion Criteria:

          1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study
             medications for which an alternative is not named in the protocol (e.g., amide-type
             local anesthetics, opioids, bupivacaine HCl, nonsteroidal anti-inflammatory drugs
             [NSAIDs])

          2. Concurrent painful physical condition that may require analgesic treatment (such as
             long-term, consistent use of opioids) in the post dosing period for pain and which, in
             the investigator's opinion, may confound the post dosing assessments

          3. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years

          4. 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

          5. Previous participation in an EXPAREL study

          6. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the investigator, could interfere with study assessments or compliance

          7. Currently pregnant, nursing, or planning to become pregnant during the study

          8. Clinically significant medical disease that, in the opinion of the investigator, would
             make participation in a clinical study inappropriate. This includes diabetic
             neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease,
             renal insufficiency, hepatic dysfunction or other conditions that would constitute a
             contraindication to participation in the study.

          9. Currently on a neuromodulating agent neuroleptic agent (e.g., gabapentin, pregabalin
             [Lyrica], duloxetine [Cymbalta], etc.)

         10. Inadequate sensory function on the foot (monofilament test)

         11. Chronic opioid use within 30 days prior to randomization (average ≥30 oral morphine
             equivalents/day)