Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® After Cesarean Delivery - Full Text View

Purpose

The purpose of this study is to evaluate the levels of morphine in a patients blood when morphine is given into the epidural space in the form of DepoDur® either alone or following a dose of lidocaine also given in the epidural space. Specifically, we are looking at pregnant women undergoing cesarean delivery who will be receiving these medications. A secondary objective is to evaluate the how well DepoDur® works for pain control, as well as its safety, when it is given either alone or following a dose of epidural lidocaine.

Condition	Intervention
Analgesia	Drug: DepoDur

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Study to Evaluate the Effects of Epidural Lidocaine Administration on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® (Morphine Sulfate Extended-release Injection) in Patients Undergoing Cesarean Delivery

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Morphine sulfate Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

PK [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PD [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Epidural DepoDur following epidural lidocaine administration Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.	Drug: DepoDur All participant underwent cesarean delivery. An epidural "top-up" anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered. Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration. Other Names: DepoDur™ EREM extended release epidural morphine
Active Comparator: Epidural DepoDur following spinal anesthetic Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.	Drug: DepoDur Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space. Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug. Other Names: DepoDur EREM extended release epidural morphine

Arms

Assigned Interventions

Active Comparator: Epidural DepoDur following epidural lidocaine administration

Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.

Drug: DepoDur

All participant underwent cesarean delivery. An epidural "top-up" anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered.

Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration.

Other Names:

DepoDur™
EREM
extended release epidural morphine

Active Comparator: Epidural DepoDur following spinal anesthetic

Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.

Drug: DepoDur

Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space.

Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug.

Other Names:

DepoDur
EREM
extended release epidural morphine

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inclusion criteria will include healthy parturients between the ages of 18 and 40 who have American Society of Anesthesiologists physical status I or II, have an uncomplicated, singleton, term pregnancy, and are scheduled to undergo cesarean delivery.

Exclusion Criteria:

Exclusion criteria for the study will included refusal to participate, American Society of Anesthesiologists physical status III or higher or any severe uncontrolled medical condition, significant systemic medical or obstetric disease, morbid obesity, opioid, NSAID, or local anesthetic allergy or intolerance, chronic analgesic or antidepressant use, accidental dural puncture, ineffective spinal or epidural, and conversion to general anesthesia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804609

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Brendan Carvalho

Stanford University

More Information

No publications provided

Responsible Party:	Brendan Carvalho, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00804609 History of Changes
Other Study ID Numbers:	SU-07022008-1228
Study First Received:	October 23, 2008
Last Updated:	May 10, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:

Anesthetics, Local
Lidocaine
Anesthetics
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Analgesics, Opioid
Analgesics
Narcotics

ClinicalTrials.gov processed this record on June 17, 2013