Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Males and females ≥ 18 years of age at Screening
Negative pregnancy test in females of childbearing potential
Scheduled for major upper abdominal surgery via an upper midline incision under general anesthesia
American Society of Anesthesiology (ASA) Physical Class 1, 2, or 3
Willing and able to use a PCA pump
Willing to receive only IV fentanyl for 72 hours post-dose to control post-operative pain
Capable of providing written informed consent and responses to pain assessment scales and neurological assessment questionnaires

Exclusion Criteria:

Morbid obesity, defined as a body mass index (BMI) ≥ 40
Scheduled to undergo surgery under regional anesthesia
Usage of analgesic medications containing morphine or codeine within three days prior to study drug administration
Chronic opioid medication usage (defined as daily opioids for more than 7 days prior to enrollment)
Suspected or documented history of sleep apnea, narcolepsy, or excessive daytime sleepiness
Female who was pregnant or lactating
History of hypersensitivity or idiosyncratic reaction to opioid medications, local anesthetics, or epinephrine
Any contraindication for the epidural administration of study drug (e.g., coagulopathy, local infection)
Administration of an investigational drug within 30 days prior to Screening
Suspected or documented history of substance abuse and/or alcoholism
Any contraindication to frequent blood PK sampling (such as significant anemia) or other barrier to obtaining timely PK samples