Status:
COMPLETED
A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery
Lead Sponsor:
EKR Therapeutics, Inc
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Postoperative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 morphin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00728832
Start Date
May 1 2002
Last Update
August 14 2008
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