Overview

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Withdrawn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:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Florida
Treatments:
Bupivacaine
Epinephrine
Epinephryl borate
Fentanyl
Morphine
Racepinephrine
Criteria
Inclusion Criteria:

- Elective C-section patients

- ASA physical status class 1-3

- Age >18 years

- Height 140-180 cm

- Singleton pregnancy

- Gestational age ≥35 weeks

Exclusion Criteria:

- Age < 18 yo

- Prisoner status

- BMI > 45 Laboring patients with epidural going for emergency C-section Opioid abuse in
the past 6 months Allergies to any of the adjuncts added to the spinal drug. Ruptured
membranes four or more previous cesarean deliveries intrauterine growth retardation,
abnormal placentation