CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 68 enrolled
Drug / intervention
Low-dose epinephrine +2 moredrug
Likely dose
Low-dose epinephrine 0.1mlfrom 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/NCT02369510
NCT02369510Phase 4Completed

Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section?

Icahn School of Medicine at Mount Sinai·interventional·Posted Feb 24, 2015·Updated Aug 30, 2017

In Brief

A Phase 4 clinical trial evaluating Low-dose epinephrine, High-dose epinephrine, and 1 other intervention for Spinal Anesthesia and Cesarean Section. Completed, enrolled 68 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 24, 2015
Enrollment StartFeb 1, 2015
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.4 years ago

Interventions

Low-dose epinephrinedrug

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

High-dose epinephrinedrug

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

No epinephrinedrug

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