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

NCT02857465 | Withdrawn Phase 3 DMC

• 1 other identifier: 2015/CHU/12
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Obstetric Pain; Other Complications of Obstetric Anesthesia - Delivered

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• Maternal satisfaction assessed by visual analogic scale

  On the morning of the next day after delivery, up to 24 hours

Other Outcomes (3)

• New-born adaptation to child-birth assessed by "Apgar score"

  up to 5 minutes after child-birth

• New-born adaptation to child-birth assessed by umbilical biochemical parameters

  umbilical blood collection up to 5 minutes after child-birth

• New-born adaptation to child-birth assessed by the rate of neonatal respiratory distress

  0-24 hours after child-birth

Study Arms (2)

Epidural analgesia + DEXAMETHASONE

EXPERIMENTAL

Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)

Drug: Dexamethasone; Drug: Ropivacaine; Drug: Sufentanil

Epidural analgesia + PLACEBO

PLACEBO COMPARATOR

Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)

Drug: Placebo; Drug: Ropivacaine; Drug: Sufentanil

Interventions

Dexamethasone DRUG

single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia

Also known as: Dexamethasone MYLAN

Epidural analgesia + DEXAMETHASONE

Placebo DRUG

single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia

Also known as: Sodium chloride LAVOISIER 0.9 %

Epidural analgesia + PLACEBO

Ropivacaine DRUG

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.

Also known as: NAROPEINE 7.5 mg/ml, anhydrous ropivacaine chlorhydrate

Epidural analgesia + DEXAMETHASONE; Epidural analgesia + PLACEBO

Sufentanil DRUG

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.

Also known as: Sufentanil Mylan 0.5 microg/mL

Epidural analgesia + DEXAMETHASONE; Epidural analgesia + PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First and single pregnancy, Full term (\> 37 wks amenorrhea), Cephalic presentation, Spontaneous labor, Epidural analgesia requested by the parturient

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

MeSH Terms

Conditions

Labor Pain

Interventions

Dexamethasone; Ropivacaine; Sufentanil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 5, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share