Postoperative Pain
Conditions
Keywords
extended release epidural morphine, morphine, thoracic epidural, pharmacokinetics, pharmacodynamics, postoperative pain, upper abdominal surgery
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.
Interventions
DRUGDepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
Sponsors
Pacira Pharmaceuticals, Inc
EKR Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| efficacy and safety profiles | — |
Outcome results
None listed