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PIEB vs PCEA With Epidural or CSE Technique. A Randomized Double Blind Clinical Trial

NCT02768272 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2017-08-10

No results posted yet for this study

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.

Conditions

  • Labor Epidural Analgesia

Interventions

DEVICE

PCEA vs PIEB

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

PROCEDURE

Epidural vs CSE

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

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Emilia Guasch, MD, PhD · Anesthesia and Intensive Care Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Spain

Study Locations

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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 NCT02768272 on ClinicalTrials.gov