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

EKR Therapeutics

Status and phase: Completed; Phase 1

Conditions: Postoperative Pain

Treatments: Drug: DepoDur (extended-release epidural morphine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00728832

SKY0401-016

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

39 participants in 5 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: DepoDur (extended-release epidural morphine)

2

Experimental group

Description:

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

Treatment:

Drug: DepoDur (extended-release epidural morphine)

3

Experimental group

Description:

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

Treatment:

Drug: DepoDur (extended-release epidural morphine)

4

Experimental group

Description:

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

Treatment:

Drug: DepoDur (extended-release epidural morphine)

5

Experimental group

Description:

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

Treatment:

Drug: DepoDur (extended-release epidural morphine)