Obstetric Pain, Other Complications of Obstetric Anesthesia - Delivered
Conditions
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.
Interventions
DRUGDexamethasone
single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia
DRUGPlacebo
single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia
DRUGRopivacaine
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.
DRUGSufentanil
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
Centre Hospitalier Universitaire de la Réunion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hourly ropivacaine consumption expressed as mg/mL used during epidural analgesia in parturient women | From the beginning to the end of epidural analgesia, that could last up to 6 hours | The administered dose of ropivacaine during epidural is used to measure the efficacy of Dexamethasone in reducing local anesthetics during labor analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dexamethasone effect maternal pain during delivery assessed by Visual Analogic Scale | From the beginning to the end of epidural analgesia, that could last up to 6 hours | Evaluation of the lowered maternal pain induced by Dexamethasone |
| Improvement of epidural analgesia assessed by the reduction of adverse effects induced by local anesthetics | From the beginning to the end of epidural analgesia, that could last up to 6 hours | Adverse effects such as nausea and emesis, maternal hypotension, maternal hyperthermia will be recorded during epidural analgesia |
| Improvement of delivery assessed by recording the number of side events (motor block, emergency cesarean, instrument-assisted delivery) | From the beginning to the end of epidural analgesia, that could last up to 6 hours | Rates of motor block, emergency cesarean, instrument-assisted delivery |
| Maternal satisfaction assessed by visual analogic scale | On the morning of the next day after delivery, up to 24 hours | Patient satisfaction visual analogic scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| New-born adaptation to child-birth assessed by the rate of neonatal respiratory distress | 0-24 hours after child-birth | Rate of neonatal respiratory distress during the first 24 hours after child-birth |
| New-born adaptation to child-birth assessed by umbilical biochemical parameters | umbilical blood collection up to 5 minutes after child-birth | Measurement of umbilical pH and lactates values at child-birth |
| New-born adaptation to child-birth assessed by Apgar score | up to 5 minutes after child-birth | Apgar score assessed twice: at 1 minute and 5 minutes after child-birth |
Outcome results
None listed