Clinical trial NCT00728832: A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery
Official title: A Phase 1 Study to Evaluate the Effects of Lidocaine/Epinephrine Test Dose Administration on the Pharmacokinetic Profile of a Single Dose of Thoracic Extended-Release Epidural Morphine in Patients Undergoing Major Upper Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postoperative Pain
Keywords: extended release epidural morphine
morphine
thoracic epidural
pharmacokinetics
pharmacodynamics
postoperative pain
upper abdominal surgery
Lead sponsor: EKR Therapeutics, Inc
Sponsor class: INDUSTRY
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2008-08-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 morphine) in patients undergoing major upper abdominal surgery. A secondary objective was to evaluate the safety and efficacy profile.


Eligibility 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

Primary outcomes:
measure: Evaluate the serum pharmacokinetic profile of a single 15-mg dose of DepoDur administered at the lower thoracic epidural space with or without a prior lidocaine-epinephrine test dose
Secondary outcomes:
measure: efficacy and safety profiles
Other outcomes:
Locations:
Study officials:
affiliation: Thomas Jefferson University
name: Eugene R Viscusi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Viscusi ER, Manvelian GZ. A randomized study of the serum pharmacokinetics of lower thoracic extended-release epidural morphine (DepoDur) after lidocaine-epinephrine test dose administration in patients undergoing upper abdominal surgery. Int J Clin Pharmacol Ther. 2009 Nov;47(11):659-70. doi: 10.5414/cpp47659.