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

Primary Purpose

Obstetric Pain, Other Complications of Obstetric Anesthesia - Delivered

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Ropivacaine
Sufentanil
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Epidural analgesia + DEXAMETHASONE

    Epidural analgesia + PLACEBO

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Dexamethasone effect maternal pain during delivery assessed by Visual Analogic Scale
    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)
    Rates of motor block, emergency cesarean, instrument-assisted delivery
    Maternal satisfaction assessed by visual analogic scale
    Patient satisfaction visual analogic scale

    Full Information

    First Posted
    July 26, 2016
    Last Updated
    March 6, 2019
    Sponsor
    Centre Hospitalier Universitaire de la Réunion
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02857465
    Brief Title
    Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome
    Acronym
    DEXAPER
    Official Title
    Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome. A Randomized Double Blind Placebo Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    French Agency for the Safety of Health Products refusal
    Study Start Date
    January 2017 (Anticipated)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de la Réunion

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstetric Pain, Other Complications of Obstetric Anesthesia - Delivered

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Epidural analgesia + DEXAMETHASONE
    Arm Type
    Experimental
    Arm Description
    Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)
    Arm Title
    Epidural analgesia + PLACEBO
    Arm Type
    Placebo Comparator
    Arm Description
    Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    Dexamethasone MYLAN
    Intervention Description
    single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Sodium chloride LAVOISIER 0.9 %
    Intervention Description
    single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Other Intervention Name(s)
    NAROPEINE 7.5 mg/ml, anhydrous ropivacaine chlorhydrate
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Sufentanil
    Other Intervention Name(s)
    Sufentanil Mylan 0.5 microg/mL
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Hourly ropivacaine consumption expressed as mg/mL used during epidural analgesia in parturient women
    Description
    The administered dose of ropivacaine during epidural is used to measure the efficacy of Dexamethasone in reducing local anesthetics during labor analgesia
    Time Frame
    From the beginning to the end of epidural analgesia, that could last up to 6 hours
    Secondary Outcome Measure Information:
    Title
    Improvement of epidural analgesia assessed by the reduction of adverse effects induced by local anesthetics
    Description
    Adverse effects such as nausea and emesis, maternal hypotension, maternal hyperthermia will be recorded during epidural analgesia
    Time Frame
    From the beginning to the end of epidural analgesia, that could last up to 6 hours
    Title
    Dexamethasone effect maternal pain during delivery assessed by Visual Analogic Scale
    Description
    Evaluation of the lowered maternal pain induced by Dexamethasone
    Time Frame
    From the beginning to the end of epidural analgesia, that could last up to 6 hours
    Title
    Improvement of delivery assessed by recording the number of side events (motor block, emergency cesarean, instrument-assisted delivery)
    Description
    Rates of motor block, emergency cesarean, instrument-assisted delivery
    Time Frame
    From the beginning to the end of epidural analgesia, that could last up to 6 hours
    Title
    Maternal satisfaction assessed by visual analogic scale
    Description
    Patient satisfaction visual analogic scale
    Time Frame
    On the morning of the next day after delivery, up to 24 hours
    Other Pre-specified Outcome Measures:
    Title
    New-born adaptation to child-birth assessed by "Apgar score"
    Description
    Apgar score assessed twice: at 1 minute and 5 minutes after child-birth
    Time Frame
    up to 5 minutes after child-birth
    Title
    New-born adaptation to child-birth assessed by umbilical biochemical parameters
    Description
    Measurement of umbilical pH and lactates values at child-birth
    Time Frame
    umbilical blood collection up to 5 minutes after child-birth
    Title
    New-born adaptation to child-birth assessed by the rate of neonatal respiratory distress
    Description
    Rate of neonatal respiratory distress during the first 24 hours after child-birth
    Time Frame
    0-24 hours after child-birth

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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