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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Obstetric Pain; Other Complications of Obstetric Anesthesia - Delivered
• Intervention / Treatment: Drug: Dexamethasone; Drug: Ropivacaine; Drug: Sufentanil; Drug: Placebo

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 Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epidural analgesia + DEXAMETHASONE; Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)	Drug: Dexamethasone; single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia; Other Names: Dexamethasone MYLAN; Drug: Ropivacaine; 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.; Other Names: NAROPEINE 7.5 mg/ml; anhydrous ropivacaine chlorhydrate; Drug: Sufentanil; 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.; Other Names: Sufentanil Mylan 0.5 microg/mL
Placebo Comparator: Epidural analgesia + PLACEBO; Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)	Drug: Ropivacaine; 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.; Other Names: NAROPEINE 7.5 mg/ml; anhydrous ropivacaine chlorhydrate; Drug: Sufentanil; 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.; Other Names: Sufentanil Mylan 0.5 microg/mL; Drug: Placebo; single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia; Other Names: Sodium chloride LAVOISIER 0.9 %

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
New-born adaptation to child-birth assessed by "Apgar score"	Apgar score assessed twice: at 1 minute and 5 minutes after child-birth	up to 5 minutes after child-birth
New-born adaptation to child-birth assessed by umbilical biochemical parameters	Measurement of umbilical pH and lactates values at child-birth	umbilical blood collection up to 5 minutes after child-birth
New-born adaptation to child-birth assessed by the rate of neonatal respiratory distress	Rate of neonatal respiratory distress during the first 24 hours after child-birth	0-24 hours after child-birth

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Ropivacaine; Sufentanil; Dsuvia
• Other Study ID Numbers: 2015/CHU/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No