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

Centre Hospitalier Universitaire de la Réunion

Status and phase: Withdrawn; Phase 3

Conditions: Obstetric Pain; Other Complications of Obstetric Anesthesia - Delivered

Treatments: Drug: Dexamethasone; Drug: Ropivacaine; Drug: Sufentanil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02857465

2015/CHU/12

Details and patient eligibility

About

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

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Epidural analgesia + DEXAMETHASONE

Experimental group

Description:

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

Treatment:

Drug: Sufentanil

Drug: Ropivacaine

Drug: Dexamethasone

Epidural analgesia + PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Sufentanil

Drug: Ropivacaine