Clinical trial NCT02857465: Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome
Official title: Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome. A Randomized Double Blind Placebo Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Obstetric Pain
Other Complications of Obstetric Anesthesia - Delivered
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hourly ropivacaine consumption expressed as mg/mL used during epidural analgesia in parturient women
timeFrame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Secondary outcomes:
measure: Improvement of epidural analgesia assessed by the reduction of adverse effects induced by local anesthetics
timeFrame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
measure: Dexamethasone effect maternal pain during delivery assessed by Visual Analogic Scale
timeFrame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
measure: Improvement of delivery assessed by recording the number of side events (motor block, emergency cesarean, instrument-assisted delivery)
timeFrame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
measure: Maternal satisfaction assessed by visual analogic scale
timeFrame: On the morning of the next day after delivery, up to 24 hours
Other outcomes:
measure: New-born adaptation to child-birth assessed by "Apgar score"
timeFrame: up to 5 minutes after child-birth
measure: New-born adaptation to child-birth assessed by umbilical biochemical parameters
timeFrame: umbilical blood collection up to 5 minutes after child-birth
measure: New-born adaptation to child-birth assessed by the rate of neonatal respiratory distress
timeFrame: 0-24 hours after child-birth
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