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

NCT ID: NCT01856166

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-06-30

Brief 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.

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

CEI-PCEA

Continuous Epidural Infusion coupled with Patient Controlled Epidural Analgesia

Group Type: ACTIVE_COMPARATOR

Release analgesia by CADD SMITHS PCEA pump

Intervention Type: DEVICE

Analgesia will be release by continuous manner with an automatic pump

Levobupivacaine

Intervention Type: DRUG

Sufentanil

Intervention Type: DRUG

PIEB-PCEA

Programmed Intermittent Epidural Bolus coupled with Patient Controlled Epidural Analgesia

Group Type: EXPERIMENTAL

Release analgesia by CADD SMITHS PIEB pump

Intervention Type: DEVICE

Analgesia will be release by bolus with an automatic pump

Levobupivacaine

Intervention Type: DRUG

Sufentanil

Intervention Type: DRUG

Interventions

Release analgesia by CADD SMITHS PCEA pump

Analgesia will be release by continuous manner with an automatic pump

Intervention Type: DEVICE

Release analgesia by CADD SMITHS PIEB pump

Analgesia will be release by bolus with an automatic pump

Intervention Type: DEVICE

Levobupivacaine

Intervention Type: DRUG

Sufentanil

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Estelle MORAU, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Montpellier - Department of gynaecology and obstetric

Locations

Hôpital Mère Enfant

Bron, , France

CHU d'Estaing

Clermont-Ferrand, , France

CHU Bicêtre

Le Kremlin-Bicêtre, , France

CHU of Montpellier

Montpellier, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 31335447 (View on PubMed)

Other Identifiers

9147

Identifier Type: -

Identifier Source: org_study_id