Status:
COMPLETED
Dilute Versus Concentrated Epidural Bupivacaine in Labor
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Pain
Labor Complications
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
This study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated (0.25%) bupivacaine. We hypothesize that patients randomize to receive the concentrated drug will require m...
Detailed Description
This study examines the effect of two different local anesthetic concentrations used for epidural analgesia in labor. Patients are randomized to receive epidural bupivacaine, either as a concentrated ...
Eligibility Criteria
Inclusion
- nulliparity, active spontaneous labor, cervical dilatation greater than 2cm and less than 5 cm, request for epidural analgesia, age between 18 to 40, American Society of Anesthesiologists (ASA) physical status I or II, body weight less than 110kg, gestational age greater than 36 completed weeks, singelton pregnancy and vertex presentation
Exclusion
- narcotic administration in the previous 3 hours, non-reassuring fetal heart rate tracing at any stage in labor prior to enrollment, previous uterine surgery, pre-eclampsia and the inability to adequately understand the consent process.
Key Trial Info
Start Date :
February 1 1998
Trial Type :
INTERVENTIONAL
End Date :
March 1 2000
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00197327
Start Date
February 1 1998
End Date
March 1 2000
Last Update
March 3 2006
Active Locations (1)
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1
Hadassah Hebrew University Medical Center
Jerusalem, Israel, 91120