Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® After Cesarean Delivery

This study is currently recruiting participants.

Verified by Stanford University, December 2008

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00804609

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 Drug: Lidocaine

MedlinePlus related topics: Cesarean Section

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
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

Further study details as provided by Stanford University:

Primary Outcome Measures:

morphine levels in the blood after Depodur given alone in the epidural space and given after lidocaine given in the epidural space

Secondary Outcome Measures:

how well pain is controlled with depodur in post-cesarean patients

Estimated Enrollment:	30
Study Start Date:	September 2008

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	Recruiting
Stanford, California, United States, 94305
Contact: Brendan Carvalho 650-861-8607 bcarvalho@stanford.edu
Principal Investigator: Brendan Carvalho
Sub-Investigator: Lindsey Marie Atkinson
Sub-Investigator: David R. Drover
Sub-Investigator: Martha Sample Tingle

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Brendan Carvalho

Stanford University

More Information

Responsible Party:	Stanford University School of Medcine ( Brendan Carvalho, Priniciple Investigator )
Study ID Numbers:	SU-07022008-1228
Study First Received:	October 23, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00804609
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Morphine
Lidocaine

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009