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

Study Overview
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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

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.

Official Title
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Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome. A Randomized Double Blind Placebo Study

Conditions
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Obstetric Pain, Other Complications of Obstetric Anesthesia - Delivered

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Placebo
* Drug: Ropivacaine
* Drug: Sufentanil


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural analgesia + DEXAMETHASONE<br>Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil) | Drug: Dexamethasone<br>* single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia<br>* Other names: Dexamethasone MYLAN;Drug: Ropivacaine<br>* 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.<br>* Other names: anhydrous ropivacaine chlorhydrate;Drug: Sufentanil<br>* 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.<br>* Other names: Sufentanil Mylan 0.5 microg/mL;|
| Placebo Comparator: Epidural analgesia + PLACEBO<br>Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil) | Drug: Placebo<br>* single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia<br>* Other names: Sodium chloride LAVOISIER 0.9 %;Drug: Ropivacaine<br>* 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.<br>* Other names: anhydrous ropivacaine chlorhydrate;Drug: Sufentanil<br>* 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.<br>* Other names: Sufentanil Mylan 0.5 microg/mL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hourly ropivacaine consumption expressed as mg/mL used during epidural analgesia in parturient women | The administered dose of ropivacaine during epidural is used to measure the efficacy of Dexamethasone in reducing local anesthetics during labor analgesia | From the beginning to the end of epidural analgesia, that could last up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of epidural analgesia assessed by the reduction of adverse effects induced by local anesthetics | Adverse effects such as nausea and emesis, maternal hypotension, maternal hyperthermia will be recorded during epidural analgesia | From the beginning to the end of epidural analgesia, that could last up to 6 hours | 
| Dexamethasone effect maternal pain during delivery assessed by Visual Analogic Scale | Evaluation of the lowered maternal pain induced by Dexamethasone | From the beginning to the end of epidural analgesia, that could last up to 6 hours | 
| Improvement of delivery assessed by recording the number of side events (motor block, emergency cesarean, instrument-assisted delivery) | Rates of motor block, emergency cesarean, instrument-assisted delivery | From the beginning to the end of epidural analgesia, that could last up to 6 hours | 
| Maternal satisfaction assessed by visual analogic scale | Patient satisfaction visual analogic scale | On the morning of the next day after delivery, up to 24 hours |