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

NCT00728832 | Completed Phase 1 DMC

• 1 other identifier: SKY0401-016
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Keywords

extended release epidural morphine; morphine; thoracic epidural; pharmacokinetics; pharmacodynamics; postoperative pain; upper abdominal surgery

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• efficacy and safety profiles

Study Arms (5)

1

ACTIVE COMPARATOR

No test dose + DepoDur + flush with 1 mL normal saline

Drug: DepoDur (extended-release epidural morphine)

2

EXPERIMENTAL

Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline

Drug: DepoDur (extended-release epidural morphine)

3

EXPERIMENTAL

Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline

Drug: DepoDur (extended-release epidural morphine)

4

EXPERIMENTAL

Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline

Drug: DepoDur (extended-release epidural morphine)

5

EXPERIMENTAL

Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline

Drug: DepoDur (extended-release epidural morphine)

Interventions

DepoDur (extended-release epidural morphine) DRUG

DepoDur with on demand boluses of IV fentanyl PCA

1; 2; 3; 4; 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EKR Therapeutics, Inc: lead
• Pacira Pharmaceuticals, Inc: collaborator

Related Publications (1)

• 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.

  PMID: 19840530 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Eugene R Viscusi, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 1, 2008
• First Posted: August 6, 2008
• Study Start: May 1, 2002
• Primary Completion: February 1, 2003
• Last Updated: August 14, 2008

Record last verified: 2008-08