Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery

Exclusion Criteria

• •1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
• •2. Planned concurrent surgical procedure.
• •3. 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 shoulder surgery and which may confound the postsurgical assessments (e.g., significant pain from other joints, chronic neuropathic pain).
• •4. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.
• •5. Smoking history of greater than 25 pack-years.
• •6. Contraindication to any one of the following: bupivacaine, oxycodone, morphine, or hydromorphone.
• •7. Use of any of the following medications within the times specified before surgery: long-acting opioid medications or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication within 24 hours.
• •8. 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), gabapentin, pregabalin (Lyrica®), 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.
• •9. Current use of systemic glucocorticosteroids within 1 month of enrollment in this study.
• •10. Use of dexmedetomidine hydrochloride (HCl) (Precedex®) within 3 days of study drug administration.
• •11. History of impaired kidney function, emphysema or other chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in extremities.
• •12. Impaired kidney function (e.g., serum creatinine level \>2 mg/dL \[176.8 µmol/L\] or blood urea nitrogen level \>50 mg/dL \[17.9 mmol/L\]) or impaired liver function (e.g., serum aspartate aminotransferase \[AST\] level \>3 times the upper limit of normal \[ULN\] or serum alanine aminotransferase \[ALT\] level \>3 times the ULN.)
• •13. Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.
• •14. Any chronic neuromuscular deficit effecting the peripheral nerves or muscles of the surgical extremity.
• •15. Any chronic condition or disease that would compromise neurological or vascular assessments.
• •16. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
• •17. Suspected or known history of drug or alcohol abuse within the previous year.
• •18. Body weight \<50 kg (110 pounds) or a body mass index \>44 kg/m2.
• •19. Previous participation in an EXPAREL study.
• •20. 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.