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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728832
• Other study ID #: SKY0401-016
• Status: Completed
• Phase: Phase 1
• First received: August 1, 2008
• Last updated: August 12, 2008
• Start date: May 2002

Study information

• Verified date: August 2008
• Source: EKR Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
EKR Therapeutics, Inc	Pacira Pharmaceuticals, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	efficacy and safety profiles			Yes