RCT of Epinephrine (None, 100mcg, and 200mcg) in a Hyperbaric Bupivacaine, Fentanyl and Morphine Spinal in C-sections.
Status:
Withdrawn
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
This is a prospective, randomized, double blind study of 75 patients (n=25 for each group) in
which epinephrine (100mcg or 200mcg) or normal saline vehicle is added to intrathecal
hyperbaric bupivacaine (0.75% bupivacaine hydrochloride in 8.25% dextrose), fentanyl, and
morphine to prolong the duration of the spinal anesthetic in scheduled cesarean deliveries.
The primary outcome of duration will be the time to T10 level sensory regression as well as
motor level regression that will be graded via the modified Bromage scale.
Repeat cesarean sections, in particular, are associated with increased operative time and
thus often performed with a spinal-epidural (CSE) technique. The epidural component is,
however, untested and may not provide adequate anesthesia, thus the higher risk of conversion
to a general anesthesia. Epinephrine is routinely used to prolong spinal anesthesia. If
effective for the duration of a repeat cesarean section it would obviate the additional time
and risks of performing the epidural and still avoid sufficient duration to avoid conversion
to a general anesthetic.