Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Stopped early · Phase 4

Conditions studied: Labor Pain

In brief

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.

Key facts

Study ID

NCT01005459

Run by

Wake Forest University

People needed

46

Starts

2009-08-01

Expected to finish

2011-12-12

Last updated by the study team

2017-11-08

Who can join

Age: 12 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• early labor (>=2cm but =<6cm cervical dilation)
• at least 12 years of age
• have an assigned ASA physical status 1 or 2
• singleton pregnancy

You may not qualify if…

• 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.

Where it is running

• Forsyth Medical Center- OB Anesthesia dept — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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