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RCT of Epinephrine (None, 100mcg, and 200mcg) in a Hyperbaric Bupivacaine, Fentanyl and Morphine Spinal in C-sections.

NCT03335293 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-11-25

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • Cesarean Section

Interventions

DRUG

100 mcg Epinephrine

This study will evaluate the optimal dose of epinephrine as an adjunct to spinal doses of 1.6 mL hyperbaric bupivacaine + 20 mcg preservative free fentanyl + 150 mcg preservative-free morphine.

OTHER

normal saline

placebo comparator

DRUG

200 mcg Epinephrine

This study will evaluate the optimal dose of epinephrine as an adjunct to spinal doses of 1.6 mL hyperbaric bupivacaine + 20 mcg preservative free fentanyl + 150 mcg preservative-free morphine.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Paul Mongan, MD · UF COMJ Department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03335293 on ClinicalTrials.gov