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Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?

NCT02369510 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-08-30

Study results available
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Summary

The purpose of this study is to investigate whether the addition of a medication called epinephrine to spinal medications prolongs the duration of the anesthesia. The medication standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain medication (morphine). These medications typically last about 2 hours. The investigators want to determine if adding epinephrine to the spinal medications prolongs the anesthetic without side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean section. Epinephrine is known to prolong the action of some local anesthetics, but the investigators want to specifically study combining it with the medications the investigators use regularly for cesarean section.

You may qualify to take part in this research study because you are having a repeat cesarean section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want to determine if epinephrine will prolong the anesthetic.

Conditions

  • Spinal Anesthesia
  • Cesarean Section

Interventions

DRUG

Low-dose epinephrine

0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications

DRUG

High-dose epinephrine

0.2ml of 1:1000 epinephrine will be added to the standard spinal medications

DRUG

No epinephrine

0.2ml of preservative-free saline will be added to the standard spinal medications

Sponsors & Collaborators

Principal Investigators

  • Daniel Katz, MD · Icahn School of Medicine at Mount Sinai

  • Yaakov Beilin, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02369510 on ClinicalTrials.gov