Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Wake Forest University (WFU)

Status and phase

Terminated

Phase 4

Conditions

Labor Pain

Treatments

Drug: Tetracaine

Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT01005459

IRB 9824

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

Female

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.