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A Comparison Study of Patient Controlled Epidural Analgesia (PCEA) With and Without Basal Infusion Using Ropivacaine 0,15% and Fentanyl μg/ml for Pain Relief in Labor, Assessment of Efficacy and Maternal Satisfaction.

NCT02084589 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2014-04-08

No results posted yet for this study

Summary

This is a prospective, randomized, double blind study, in which a comparison of patient controlled epidural analgesia (PCEA) of continuous background infusion with demand dose and demand only, using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor, is being investigated. The purpose of the study is the assessment of the efficacy of labor analgesia and maternal satisfaction.

Written informed consent is obtained by all parturients. Non invasive monitor of blood pressure, heart rate, SpO2, ECG for the patient and a continuous monitoring of the fetal heart rate is being placed.

The participants are randomized in two groups, both receiving the same drug (ropivacaine 0,15% and fentanyl 2μg/ml). Group 0 receives demand dose of 5 ml with lockout of 10 minutes. Group 1 receives background infusion of 5 ml/h and demand dose of 5 ml with lockout 10 minutes.

All parturients have to be instructed to self administration of epidural bolus dose when they experience mild to moderate pain. Both parturient and anesthetist who conducts the study and treat breakthrough pain, are blind to group assignment.

After the last suture, total volume of epidural infusions of PCEA, total infused drug of PCEA pump, number of delivered PCEA boluses and manual rescue doses are being calculated. Time of delivery, mode of delivery, Apgar scores, and overall maternal satisfaction scores, neonate pH and Hct of the patient (ABGS), as well as possible need of newborn cardiopulmonary resuscitation are also recorded.

Conditions

  • Labor Pain

Interventions

OTHER

PCEA with basal infusion and demand dose using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor

OTHER

PCEA without basal infusion (demand only) using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor

Sponsors & Collaborators

  • Paraskevi Matsota

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-02-28

Countries

  • Greece

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 NCT02084589 on ClinicalTrials.gov