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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Sufentanil; Device: Release analgesia by CADD SMITHS PCEA pump; Device: Release analgesia by CADD SMITHS PIEB pump

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hôpital Mère Enfant
  • Clermont Ferrand, France, 63003
    • CHU d'Estaing
  • Le Kremlin Bicêtre, France, 94275
    • CHU Bicêtre
  • Montpellier, France, 34000
    • CHU of MONTPELLIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CEI-PCEA; Continuous Epidural Infusion coupled with Patient Controlled Epidural Analgesia	Drug: Levobupivacaine; Drug: Sufentanil; Device: Release analgesia by CADD SMITHS PCEA pump; Analgesia will be release by continuous manner with an automatic pump
Experimental: PIEB-PCEA; Programmed Intermittent Epidural Bolus coupled with Patient Controlled Epidural Analgesia	Drug: Levobupivacaine; Drug: Sufentanil; Device: Release analgesia by CADD SMITHS PIEB pump; Analgesia will be release by bolus with an automatic pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instrumental delivery rate		up to 10 hours
Pain during the end of labor		up to 10 hours
Efficacity of epidural analgesia		up to 10 hours
Efficacity of epidural analgesia	Efficacity of epidural analgesia is defined by a EVN score < 3 at several times of delivery.	up to 10 hours
Presence of motor block	Presence of motor block is estimated with Bromage and Straigh Raising leg scales.	Up to 10 hours

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Estelle MORAU, PhD, CHU Montpellier - Department of gynaecology and obstetric

Publications and helpful links

General Publications

• Morau E, Jaillet M, Storme B, Nogue E, Bonnin M, Chassard D, Benhamou D, Nagot N, Dadure C. Does programmed intermittent epidural bolus improve childbirth conditions of nulliparous women compared with patient-controlled epidural analgesia?: A multicentre, randomised, controlled, triple-blind study. Eur J Anaesthesiol. 2019 Oct;36(10):755-762. doi: 10.1097/EJA.0000000000001053.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimated): May 17, 2013

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pregnancy; delivery; Nulliparous; Singleton
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Levobupivacaine; Sufentanil
• Other Study ID Numbers: 9147