CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 240 enrolled
Drug / intervention
PCEA vs PIEB +1 moredevice
Likely dose
Not stated in 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/NCT02768272
NCT02768272Phase 4Completed

A Randomized Double Blind Clinical Trial Comparing Programed Intermittent Epidural Boluses (PIEB) Versus Patient Controlled Epidural Analgesia (PCEA) With Epidural or Combined Spinal-epidural (CSE) Technique

Hospital Universitario La Paz·interventional·Posted May 11, 2016·Updated Aug 10, 2017

In Brief

A Phase 4 clinical trial evaluating PCEA vs PIEB and Epidural vs CSE for Labor Epidural Analgesia. Completed, enrolled 240 participants across 1 site.

Detailed Summary

The investigators have design a randomized double blind clinical trial to know the incidence of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical dilation) comparing two epidural analgesic regimes: programed intermittent epidural boluses versus patient controlled epidural analgesia. The role of the epidural technique (epidural versus combined spinal-epidural) in the incidence of BP will be also evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 11, 2016
Enrollment StartMar 1, 2016
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.1 years ago

Interventions

PCEA vs PIEBdevice

We evaluate the relation between the distribution of L-bupivacaine plus fentanyl in the epidural space and the incedence of breaktrough pain during labor

Epidural vs CSEprocedure

We evaluate the relation between the type of epidural technique and the incedence of breaktrough pain during labor