Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® After Cesarean Delivery
Information source: Stanford University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Analgesia
Intervention: Depodur (Drug); Lidocaine (Drug)
Phase: N/A
Status: Recruiting
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: Non-Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: morphine levels in the blood after Depodur given alone in the epidural space and given after lidocaine given in the epidural space
Secondary outcome: how well pain is controlled with depodur in post-cesarean patients
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; Recruiting
Brendan Carvalho, Phone: 650-861-8607, Email: bcarvalho@stanford.edu
Brendan Carvalho, Principal Investigator
Lindsey Marie Atkinson, Sub-Investigator
David R. Drover, Sub-Investigator
Martha Sample Tingle, Sub-Investigator
Additional Information
Starting date: September 2008
Last updated: December 15, 2008
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