Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE
This trial is active, not recruiting.
|Sponsor||Wake Forest School of Medicine|
|Start date||August 2009|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT01005459, IRB 9824|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, investigator)|
Spinal analgesic duration
time frame: 1-2 hrs
Female participants at least 12 years old.
Inclusion Criteria: - early labor (>=2cm but =<6cm cervical dilation) - at least 12 years of age - have an assigned ASA physical status 1 or 2 - singleton pregnancy Exclusion Criteria: - contraindications to neuraxial anesthesia - with allergies to drugs used in the study - have an assigned ASA status 3 or 4 - advanced labor (> 6cm cervical dilation) - less than 12 years of age - Patients with the potential for distorted epidural anatomy, such as Harrington rods or prior back surgery, will also be excluded.
|Official title||Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia|
|Principal investigator||Peter H. Pan, MD|
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