MedTrace Logo

Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects

NCT02159807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2019-01-03

Study results available
· View outcomes & findings →

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.

Conditions

  • Pregnancy

Interventions

DRUG

Bupivacaine

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

DRUG

Fentanyl

20 micrograms routinely administered in combination in the spinal anesthetic

Sponsors & Collaborators

  • St. Luke's-Roosevelt Hospital Center

    lead OTHER

Principal Investigators

  • Jonathan Epstein, M.D. · Mount Sinai Roosevelt Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-24
Primary Completion
2017-12-29
Completion
2017-12-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02159807 on ClinicalTrials.gov