Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation

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, NSAIDs)
• •2. Documented history of long-term diabetes (≥10 years) or severe peripheral vascular disease
• •3. Renal (serum creatinine level \>2mg/dL \[176.8 μmol/L\]) or hepatic dysfunction (serum alanine or aspartame transferase \> 3 times the upper limit of normal)
• •4. 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
• •5. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
• •6. 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
• •7. Previous participation in an EXPAREL study
• •8. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
• •9. Currently pregnant, nursing, or planning to become pregnant during the study
• •10. Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
• •11. Currently on neuroleptic agent \[e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.\]
• •12. Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)