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Completed

NCT Number: NCT01856166

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

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.

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Key information

Conditions

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Mère Enfant, Bron, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Release analgesia by CADD SMITHS PCEA pump

Device

Analgesia will be release by continuous manner with an automatic pump

Release analgesia by CADD SMITHS PIEB pump

Device

Analgesia will be release by bolus with an automatic pump

Levobupivacaine

Drug

Sufentanil

Drug

Primary outcomes

  1. Occurence of a specific clinical criteria which can lead to a complication of the delivery

    Time frame: Up to 10 hours

    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

Secondary outcomes

  1. Instrumental delivery rate

    Time frame: up to 10 hours

  2. Pain during the end of labor

    Time frame: up to 10 hours

  3. Efficacity of epidural analgesia

    Time frame: up to 10 hours

  4. Efficacity of epidural analgesia

    Time frame: up to 10 hours

    Efficacity of epidural analgesia is defined by a EVN score < 3 at several times of delivery.

  5. Presence of motor block

    Time frame: Up to 10 hours

    Presence of motor block is estimated with Bromage and Straigh Raising leg scales.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: PIEB

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
May 17, 2013
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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