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

Obstetric Pain Clinical Trial

— DEXAPER  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02857465
• Other study ID #: 2015/CHU/12
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Obstetric Pain
• Other Complications of Obstetric Anesthesia - Delivered

Intervention

Drug:
• Dexamethasone
single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia
• Placebo
single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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