PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in Nulliparous

Pregnancy Clinical Trial

— PIEB  

Official title:

Programmed Intermittent Epidural Bolus Coupled With PCEA (PIEB-PCEA) Versus Continuous Epidural Infusion Coupled With PCEA (CEI-PCEA) for Labor Analgesia in Nulliparous: Effects on Labor Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856166
• Other study ID #: 9147
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented delivery rates.

To assess the best maintainance regimen of epidural analgesia during labor the investigators plan to include 300 nulliparous in this multicenter randomized, double blind trial. The primary outcome will be a composite set of criteria that can lead to instrumented delivery. Secondary outcome will focus on analgesia motor block and satisfaction.

Description:

Patients will be informed during the anaesthetic consultation and recruited at the beginning of the labor if they comply with inclusion criteria. Habitual proceedings of the placing and induction of epidural analgesia (Local Anaesthetics (AL): Levobupivacaine 0.100% 15mL Sufentanil 10µg). Patients who will not obtain at 30min a pain score < 1/10 will be excluded (epidural analgesia not functional). The upkeep of analgesia will be provided by an automatic pump and randomized in: classic pump and new pump. The mixture used will be the same in the 2 groups: Levobupivacaine 0.0100% + Sufentanil 0.5µg/mL. The classic pump administers AL with a continuous output (8mL/h)even though the new pump administers AL in bolus (8mL every hour; beginning 1h after the induction). The classic pump is a pump CADD SMITHS PCEA (Patient Controlled Epidural Analgesia) with the programming: continuous output 8mL/h; Additional bolus if necessary: 8mL; Maximal dose by hour: 24mL.

The new pump is a pump CADD SMITHS called PIEB (Programmed Intermittent Epidural Bolus) with the programming: intermittent bolus 8mL every hour; Additional bolus if necessary: 8mL; Ban period during 10min between patient bolus and automatic bolus; Maximal dose by hour: 24mL.

In case of the pain reappears and which is not calmed with 2 successive patient bolus, the anaesthetist will be called for the evaluation and administration of a doctor bolus if necessary (Levobupivacaine 0.125% 5mL associated with 50µg of Clonidine).

Collected data will be demographic data, data about the obstetrical labor proceedings, data about pain, motor block, maternal satisfaction, total quantity of administered analgesia, number of patient and doctor bolus wich are asked and administered and neonatal data.

Endpoints will be collected by a doctor in blind of the type of pump (the 2 pumps are the same extern aspect, only the intern programming is different).

In case of caesarean during the labor, patient will be excluded of the study. When a decision of extraction will be taken, patient will receive a bolus of AL according to the anaesthetist decision but not accounted for the dose calculation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Nulliparous patient with a spontaneous labor at full term, from a normal pregnancy, carrier a singleton in cephalic position, with a distension <4cm and eligible for an epidural analgesia

• Patient has signed informed consent

• Patient affiliated or beneficiary of a social medical insurance

• Patient aged between 18 and 44 years old

Exclusion Criteria:

• Morphinic administration before the care

• Anomaly of fetal cardiac rate

• Fetal or maternal anomalies wich don't allow to evaluate motor block

• Known uterine malformation

• Contraindications for thrusts for pregnancy

• Patient protected by law

• Patient under guardianship

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Release analgesia by CADD SMITHS PCEA pump
Analgesia will be release by continuous manner with an automatic pump
• Release analgesia by CADD SMITHS PIEB pump
Analgesia will be release by bolus with an automatic pump

Drug:
• Levobupivacaine

• Sufentanil

Locations

Country	Name	City	State
France	Hôpital Mère Enfant	Bron
France	CHU d'Estaing	Clermont Ferrand
France	CHU Bicêtre	Le Kremlin Bicêtre
France	CHU of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of a specific clinical criteria which can lead to a complication of the delivery	Specific clinical criteria are: Type of posterior engagement; Type of posterior extrication; Duration of waiting at complete dilatation > 3 hours; Duration of expulsive efforts > 40 minutes; Foetal bradycardia < 100 BPM during 1 minute at least	Up to 10 hours
Secondary	Instrumental delivery rate		up to 10 hours
Secondary	Pain during the end of labor		up to 10 hours
Secondary	Efficacity of epidural analgesia		up to 10 hours
Secondary	Efficacity of epidural analgesia	Efficacity of epidural analgesia is defined by a EVN score < 3 at several times of delivery.	up to 10 hours
Secondary	Presence of motor block	Presence of motor block is estimated with Bromage and Straigh Raising leg scales.	Up to 10 hours