Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery
Condition: Postoperative Pain Management
MeSH terms: Pain, Postoperative
Intervention: EXPAREL and bupivacaine HCl; Bupivacaine HCl
Intervention description: Drug: EXPAREL EXPAREL and bupivacaine HCl
Other Name: bupivacaine liposome injectable suspension Drug: Bupivacaine Single dose of bupivacaine HCl 0.5%
Other Name: bupivacaine HCl; Drug: Bupivacaine Single dose of bupivacaine HCl 0.5%
Other Name: bupivacaine HCl
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective: The primary objective of this study is to compare postsurgical pain
      control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine
      HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal
      fusion surgery.

      Secondary Objectives: The secondary objectives of this study are to compare additional
      efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with
      bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar
      posterior spinal fusion surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, at least 18 years of age at screening.

          2. Primary surgical indication is lumbar pain, radiculopathy, disc degeneration, disc
             herniation, foraminal stenosis, or 1-2 level spondylolisthesis or deformity.

          3. Scheduled to undergo primary, 1-2 level, open lumbar spinal fusion surgery under
             general anesthesia.

          4. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.

          5. Female subjects must be surgically sterile; or at least 2 years postmenopausal; or
             have a monogamous partner who is surgically sterile; or practicing double-barrier
             contraception; or practicing abstinence (must agree to use double-barrier
             contraception in the event of sexual activity); or using an insertable, injectable, or
             transdermal, contraceptive approved by the FDA for greater than 2 months prior to
             screening. All women of childbearing potential (ie, premenopausal without permanent
             sterilization) must commit to the use of an acceptable form of birth control for the
             duration of the study and for 30 days after completion of the study.

          6. Able to provide informed consent, adhere to the study visit schedule, and complete all
             study assessments.

        Exclusion Criteria:

          1. Currently pregnant, nursing, or planning to become pregnant during the study or within
             1 month after study drug administration.

          2. Serious spinal conditions (to include cauda equina syndrome, infection, tumor,
             fracture, or severe osteoporosis [ie, if taking Bisphosphonate or TNF-α blockers]).

          3. Planned anterior or lateral incisions

          4. Previous spinal surgery at the same level other than microdiscectomy or
             hemilaminectomy (eg, bi-lateral laminectomy, fusion).

          5. Planned concurrent surgical procedure.

          6. Identification of a dural tear during surgery will be an intra-operative exclusion
             unless it is well repaired (no evidence of cerebrospinal fluid [CSF] leak with
             Valsalva and no plan to restrict activity post-operatively). Any injury to the nerve
             root occurring during surgery will also be considered an intra-operative exclusion.

          7. Concurrent painful physical condition that may require analgesic treatment (such as an
             NSAID or opioid) in the postsurgical period for pain that is not strictly related to
             the spinal surgery and which may confound the postsurgical assessments.

          8. Comorbidity impacting current physical function or Investigator opinion that it may
             impact postsurgical rehabilitation.

          9. Allergy, hypersensitivity, or contraindication to any of the study medications (ie,
             bupivacaine, oxycodone, morphine, hydromorphone, gabapentin, acetaminophen, or
             cyclobenzaprine) for which an alternative medication is not provided in the protocol.

         10. Use of any of the following medications within the times specified before surgery:
             long-acting opioid medication (eg, morphine including MS Contin®, hydromorphone
             [Dilaudid®], oxycodone [Oxycontin®], methadone) daily for more than 3 months duration
             or within 3 days of surgery. Patients receiving short-acting opioids or NSAIDs should
             be at a steady or plateau dose. Such patients should require or receive no more than
             40 mg morphine (oral) equivalents (eg, approximately 5 mg oxycodone) within 24 hours
             of surgery.

         11. Initiation of treatment with any of the following medications within 1 month of study
             drug administration or if the medication(s) are being given to control pain: selective
             serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors
             (SNRIs), or duloxetine (Cymbalta®). If a subject is taking one of these medications
             for a reason other than pain control, he or she must be on a stable dose for at least
             1 month prior to study drug administration.

         12. Current use of systemic glucocorticosteroids within 1 month of enrollment in this
             study.

         13. Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration.

         14. History of coronary or vascular stent placed within the past 3 months (may be extended
             to 1 year if medically indicated per physician discretion).

         15. Have been treated for a deep vein thrombosis, pulmonary embolism, myocardial
             infarction, or ischemic stroke within the past 6 months (may be extended to 1 year if
             medically indicated per physician discretion).

         16. Severely impaired renal (eg, serum creatinine clearance ≤ 30) or hepatic function (eg,
             serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN]
             or serum alanine aminotransferase [ALT] level >3 x ULN).

         17. Any neurologic or psychiatric disorder that might impact postsurgical pain or
             interfere with study assessments.

         18. Malignancy in the last 2 years, per physician discretion.

         19. History of misuse, abuse, or dependence on opioid analgesics, other prescription
             drugs, illicit drugs, or alcohol as defined in DSM-IV. Dependence or chronic opioid
             use will be defined as use of more than 30 morphine equivalents per day during the
             prior 90 days.

         20. Failure to pass the alcohol breath test or urine drug screen positive for illicit
             drugs.

         21. Body weight <50 kg (110 pounds) or a body mass index >44 kg/m2.

         22. Subjects receiving Worker's compensation for a disability or who are involved in
             litigation.

         23. Previous participation in an EXPAREL study.

         24. 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.