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

This study has been completed.
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by:
EKR Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00728832
First received: August 1, 2008
Last updated: August 12, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: DepoDur (extended-release epidural morphine)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by EKR Therapeutics, Inc:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacy and safety profiles [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: May 2002
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
No test dose + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
Experimental: 2
Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
Experimental: 3
Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
Experimental: 4
Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
Experimental: 5
Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728832

Sponsors and Collaborators
EKR Therapeutics, Inc
Pacira Pharmaceuticals, Inc
Investigators
Principal Investigator: Eugene R Viscusi, MD Thomas Jefferson University
  More Information

No publications provided by EKR Therapeutics, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eugene R. Viscusi, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00728832     History of Changes
Other Study ID Numbers: SKY0401-016
Study First Received: August 1, 2008
Last Updated: August 12, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by EKR Therapeutics, Inc:
extended release epidural morphine
morphine
thoracic epidural
pharmacokinetics
pharmacodynamics
postoperative pain
upper abdominal surgery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014