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Intermittent Automated Devices for Labor Analgesia in Emilia Romagna

NCT02710877 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2018-03-27

No results posted yet for this study

Summary

The study aims to determine whether the use of automated intermittent devices for labor analgesia could prevent the increase of instrumental deliveries, with same analgesia.

Moreover it will evaluate if automated devices can allow a reduction of health-care burden.

Conditions

  • Labor Pain

Interventions

DEVICE

Programmed Intermittent bolus

Programmed epidural bolus of 10 ml mixture every 75 minutes, plus patient controlled bolus of 5 ml same mixture; lock-out 15 minutes.

OTHER

Manual epidural bolus

Epidural bolus of 15 ml levobupivacaine and sufentanyl 10 mcg or 5 mcg administered by anesthesist on maternal request.

DRUG

Levobupivacaine

Levobupivacaine 0,0625% through peridural catheter

DRUG

Sufentanil 4 mcg

Sufentanil 0,4 mcg/ml through peridural catheter

DRUG

Sufentanil 5 mcg

Sufentanil 5 mcg through peridural catheter

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    lead OTHER

Principal Investigators

  • Massimo Girardis, PhD · University of Modena and Reggio Emilia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-23
Primary Completion
2017-12-27
Completion
2018-02-28

Countries

  • Italy

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 NCT02710877 on ClinicalTrials.gov