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

Phase 3

Withdrawn

• Conditions: Obstetric Pain; Other Complications of Obstetric Anesthesia - Delivered
• Interventions: Drug: Placebo; Drug: Dexamethasone; Drug: Ropivacaine; Drug: Sufentanil

• Registration Number: NCT02857465
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Study Timeline

• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Study Start: 2017-01
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural analgesia + PLACEBO	Placebo	Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)
Epidural analgesia + PLACEBO	Ropivacaine	Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)
Epidural analgesia + DEXAMETHASONE	Ropivacaine	Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)
Epidural analgesia + DEXAMETHASONE	Dexamethasone	Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)
Epidural analgesia + DEXAMETHASONE	Sufentanil	Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)
Epidural analgesia + PLACEBO	Sufentanil	Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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
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