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

NCT ID: NCT00728832

Last Updated: 2008-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

DepoDur (extended-release epidural morphine)

Intervention Type DRUG

DepoDur with on demand boluses of IV fentanyl PCA

2

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

Group Type EXPERIMENTAL

DepoDur (extended-release epidural morphine)

Intervention Type DRUG

DepoDur with on demand boluses of IV fentanyl PCA

3

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

Group Type EXPERIMENTAL

DepoDur (extended-release epidural morphine)

Intervention Type DRUG

DepoDur with on demand boluses of IV fentanyl PCA

4

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

Group Type EXPERIMENTAL

DepoDur (extended-release epidural morphine)

Intervention Type DRUG

DepoDur with on demand boluses of IV fentanyl PCA

5

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

Group Type EXPERIMENTAL

DepoDur (extended-release epidural morphine)

Intervention Type DRUG

DepoDur with on demand boluses of IV fentanyl PCA

Interventions

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DepoDur (extended-release epidural morphine)

DepoDur with on demand boluses of IV fentanyl PCA

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role collaborator

EKR Therapeutics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Thomas Jefferson University

Principal Investigators

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Eugene R Viscusi, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

References

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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.

Reference Type DERIVED
PMID: 19840530 (View on PubMed)

Other Identifiers

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SKY0401-016

Identifier Type: -

Identifier Source: org_study_id