Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur� After Cesarean Delivery
Information source: Stanford University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Analgesia
Intervention: DepoDur (Drug); DepoDur (Drug)
Phase: N/A
Status: Completed
Sponsored by: Stanford University Official(s) and/or principal investigator(s): Brendan Carvalho, Principal Investigator, Affiliation: Stanford University
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: PK
Secondary outcome: PD
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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.
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information
Starting date: September 2008
Last updated: May 10, 2011
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