CompletedNCT00728832Updated Aug 14, 2008

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

A Phase 1 interventional study of DepoDur (extended-release epidural morphine) in Postoperative Pain, sponsored by EKR Therapeutics, Inc. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-14.

Sponsored by EKR Therapeutics, Inc · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 39
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Postoperative Pain

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Pain, Postoperative 5,093

Keywords

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

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 39 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

This is the only study on the registry with EKR Therapeutics, Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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

Phase: Phase 1
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 39 participants (actual)

Study arms

Active comparator
1
No test dose + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
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)
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)
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)
Experimental
5
Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)

Interventions

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

What researchers measure

Primary outcomes

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

efficacy and safety profiles

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 19840530 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00728832
Lead sponsor: EKR Therapeutics, Inc
Collaborators: Pacira Pharmaceuticals, Inc
First posted: Aug 6, 2008
Start date: May 2002
Primary completion: Feb 2003
Last update: Aug 14, 2008

Study contacts

Eugene R Viscusi, MD

principal investigator · Thomas Jefferson University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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