Last reviewed · How we verify
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
To evaluate the levels of morphine in a patient's 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.
Details
| Lead sponsor | Stanford University |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2008-09 |
| Completion | 2010-12 |
Conditions
- Epidural Analgesia, Obstetric
Interventions
- DepoDur following epidural lidocaine
- DepoDur following spinal anesthetic
Primary outcomes
- Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM) — a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-dose
The primary end point was to evaluate the pharmacokinetic profiles of EREM after either no epidural lidocaine or after an epidural lidocaine top-up for cesarean delivery.
Countries
United States