PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in Nulliparous (PIEB)
|ClinicalTrials.gov Identifier: NCT01856166|
Recruitment Status : Unknown
Verified May 2013 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : May 17, 2013
Last Update Posted : January 9, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Device: Release analgesia by CADD SMITHS PCEA pump Device: Release analgesia by CADD SMITHS PIEB pump Drug: Levobupivacaine Drug: Sufentanil||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|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|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||June 2016|
Active Comparator: CEI-PCEA
Continuous Epidural Infusion coupled with Patient Controlled Epidural Analgesia
Device: Release analgesia by CADD SMITHS PCEA pump
Analgesia will be release by continuous manner with an automatic pumpDrug: Levobupivacaine Drug: Sufentanil
Programmed Intermittent Epidural Bolus coupled with Patient Controlled Epidural Analgesia
Device: Release analgesia by CADD SMITHS PIEB pump
Analgesia will be release by bolus with an automatic pumpDrug: Levobupivacaine Drug: Sufentanil
- 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
- Instrumental delivery rate [ Time Frame: up to 10 hours ]
- Pain during the end of labor [ Time Frame: up to 10 hours ]
- Efficacity of epidural analgesia [ Time Frame: up to 10 hours ]
- 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.
- Presence of motor block [ Time Frame: Up to 10 hours ]Presence of motor block is estimated with Bromage and Straigh Raising leg scales.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856166
|Contact: Estelle MORAU, MDfirstname.lastname@example.org|
|Hôpital Mère Enfant||Recruiting|
|Bron, France, 69500|
|Contact: Dominique CHASSARD, MD PhD 0472129763 email@example.com|
|Principal Investigator: Dominique CHASSARD, PU-PH|
|Clermont Ferrand, France, 63003|
|Contact: Martine BONNIN, MD 0472129763 firstname.lastname@example.org|
|Principal Investigator: Martine BONNIN, MD|
|Sub-Investigator: Brigitte STORME, MD|
|Le Kremlin Bicêtre, France, 94275|
|Contact: Dan BENHAMOU, MD-PHD email@example.com|
|Principal Investigator: Dan BENHAMOU, MD PhD|
|CHU of Montpellier||Recruiting|
|Montpellier, France, 34000|
|Contact: Estelle MORAU, PhD 0665849512 firstname.lastname@example.org|
|Contact: Claire CHAUVETON 0467330924 email@example.com|
|Principal Investigator: MORAU Estelle, MD|
|Sub-Investigator: Aurélien BONNAL, MD|
|Sub-Investigator: Pascal COLSON, MD PhD|
|Sub-Investigator: Jacques DUBOURDIEU, MD|
|Sub-Investigator: Charles LEGOUX, MD|
|Sub-Investigator: Marie BARBIER, MD|
|Principal Investigator:||Estelle MORAU, PhD||CHU Montpellier - Department of gynaecology and obstetric|