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Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome

NCT02857465 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-03-07

No results posted yet for this study

Summary

To assess the efficacy of epidural dexamethasone administration, compared to placebo, in reducing local anesthetics consumption during labor epidural analgesia in parturient women

Conditions

  • Obstetric Pain
  • Other Complications of Obstetric Anesthesia - Delivered

Interventions

DRUG

Dexamethasone

single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia

DRUG

Placebo

single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia

DRUG

Ropivacaine

NAROPEINE 7.5 mg/mL is diluted at the concentration of 1 mg/mL prior to the epidural use. The perfused dose depends on the efficacy of analgesia in reducing the delivery labor pain.

DRUG

Sufentanil

Sufentanil 0.5 mg/L is used as solution for injection for epidural analgesia and used in combination with ropivacaine. The administered dose is bolus of 15 to 20 micrograms diluted into 10 mL.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de la Réunion

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-06-30
Completion
2017-06-30

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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 NCT02857465 on ClinicalTrials.gov