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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-06-30

Brief Summary

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

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Detailed Description

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It is hypothesized that reducing the consumption of local anesthetics during labor epidural analgesia could lower their side effects (rate of motor block, nausea and emesis during labor, maternal hypotension, maternal fever) and improve the duration of the second part of the labor, and the new-born adaptation to child-birth and during the first 24 hours. The use of instruments for assisted vaginal delivery and the needs to perform emergency cesarean could also be impacted.

The efficacy of the dexamethasone will be assessed by the hourly Ropivacaine consumption (milligrams/hour) measured from randomization time to the end of epidural analgesia.

Conditions

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Obstetric Pain Other Complications of Obstetric Anesthesia - Delivered

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Epidural analgesia + DEXAMETHASONE

Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

Ropivacaine

Intervention Type DRUG

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.

Sufentanil

Intervention Type DRUG

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.

Epidural analgesia + PLACEBO

Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Ropivacaine

Intervention Type DRUG

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.

Sufentanil

Intervention Type DRUG

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.

Interventions

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Dexamethasone

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

Intervention Type DRUG

Placebo

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Dexamethasone MYLAN Sodium chloride LAVOISIER 0.9 % NAROPEINE 7.5 mg/ml anhydrous ropivacaine chlorhydrate Sufentanil Mylan 0.5 microg/mL

Eligibility Criteria

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Inclusion Criteria

* First and single pregnancy, Full term (\> 37 wks amenorrhea), Cephalic presentation, Spontaneous labor, Epidural analgesia requested by the parturient

Exclusion Criteria

* Minor patient, Planned cesarean section, Gestational hypertension and preeclampsia, Gestational diabetes, opioids or ocytocin administration before epidural analgesia preparation, Allergy to dexamethasone, Untreated gastroduodenal ulcer, epidural analgesia contraindications

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No