Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE
The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia|
- Spinal analgesic duration [ Time Frame: 1-2 hrs ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: tetracaine 2mg||
Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
|Active Comparator: Bupivacaine 2 mg||
Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
|Contact: Lynnette Harris, BSNfirstname.lastname@example.org|
|United States, North Carolina|
|Forsyth Medical Center-Sara Lee Center for Women's Health - OB Anesthesia dept||Recruiting|
|Winston-Salem, North Carolina, United States, 27103|
|Contact: Lynnette C Harris, BSN 336-718-6049 email@example.com|
|Sub-Investigator: John A Thomas, MD|
|Sub-Investigator: Laura Dean, MD|
|Principal Investigator:||Peter H. Pan, MD||WFUHS|