CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 170 enrolled
Drug / intervention
Bupivacaine +1 moredrug
Likely dose
Fentanyl 20 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02159807
NCT02159807N/ACompleted
CompareCT.gov

Randomized Double-blinded Study Designed to Optimize the Dose of Bupivacaine in Combined Spinal Epidurals to Reduce the Incidence of Fetal Bradycardia and Maternal Hypotension

St. Luke's-Roosevelt Hospital Center·interventional·Posted Jun 10, 2014·Updated Jan 3, 2019

In Brief

A clinical study evaluating Bupivacaine and Fentanyl for Pregnancy. Completed, enrolled 170 participants across 1 site.

Detailed Summary

The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor floor (depending on the physician preference) but the idea is to quantify safety, efficacy and side effects for each of these doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 10, 2014
Enrollment StartApr 24, 2015
Primary CompletionDec 29, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.1 years ago

Interventions

Bupivacainedrug

The dose of bupivacaine administered intrathecally during placement of the spinal anesthetic.

Fentanyldrug

20 micrograms routinely administered in combination in the spinal anesthetic