A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test dose administration on the PK profile of a single epidural dose of DepoDur (extended-release epidural morphine) in patients undergoing major upper abdominal surgery. A secondary objective was to evaluate the safety and efficacy profile.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EKR Therapeutics, Inc
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Morphine

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