Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-24 @ 4:11 AM
Study NCT ID:
NCT01856166
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2013-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in Nulliparous
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-27', 'studyFirstSubmitDate': '2013-04-29', 'studyFirstSubmitQcDate': '2013-05-16', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of a specific clinical criteria which can lead to a complication of the delivery', 'timeFrame': 'Up to 10 hours', 'description': 'Specific clinical criteria are:\n\n* Type of posterior engagement\n* Type of posterior extrication\n* Duration of waiting at complete dilatation \\> 3 hours\n* Duration of expulsive efforts \\> 40 minutes\n* Foetal bradycardia \\< 100 BPM during 1 minute at least'}], 'secondaryOutcomes': [{'measure': 'Instrumental delivery rate', 'timeFrame': 'up to 10 hours'}, {'measure': 'Pain during the end of labor', 'timeFrame': 'up to 10 hours'}, {'measure': 'Efficacity of epidural analgesia', 'timeFrame': 'up to 10 hours'}, {'measure': 'Efficacity of epidural analgesia', 'timeFrame': 'up to 10 hours', 'description': 'Efficacity of epidural analgesia is defined by a EVN score \\< 3 at several times of delivery.'}, {'measure': 'Presence of motor block', 'timeFrame': 'Up to 10 hours', 'description': 'Presence of motor block is estimated with Bromage and Straigh Raising leg scales.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nulliparous', 'Singleton', 'delivery', 'pregnancy'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '31335447', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented delivery rates.\n\nTo 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.', 'detailedDescription': '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.\n\nThe 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.\n\nIn 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).\n\nCollected 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.\n\nEndpoints 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).\n\nIn 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n* Patient has signed informed consent\n* Patient affiliated or beneficiary of a social medical insurance\n* Patient aged between 18 and 44 years old\n\nExclusion Criteria:\n\n* Morphinic administration before the care\n* Anomaly of fetal cardiac rate\n* Fetal or maternal anomalies wich don't allow to evaluate motor block\n* Known uterine malformation\n* Contraindications for thrusts for pregnancy\n* Patient protected by law\n* Patient under guardianship"}, 'identificationModule': {'nctId': 'NCT01856166', 'acronym': 'PIEB', 'briefTitle': 'PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in Nulliparous', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '9147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CEI-PCEA', 'description': 'Continuous Epidural Infusion coupled with Patient Controlled Epidural Analgesia', 'interventionNames': ['Device: Release analgesia by CADD SMITHS PCEA pump', 'Drug: Levobupivacaine', 'Drug: Sufentanil']}, {'type': 'EXPERIMENTAL', 'label': 'PIEB-PCEA', 'description': 'Programmed Intermittent Epidural Bolus coupled with Patient Controlled Epidural Analgesia', 'interventionNames': ['Device: Release analgesia by CADD SMITHS PIEB pump', 'Drug: Levobupivacaine', 'Drug: Sufentanil']}], 'interventions': [{'name': 'Release analgesia by CADD SMITHS PCEA pump', 'type': 'DEVICE', 'description': 'Analgesia will be release by continuous manner with an automatic pump', 'armGroupLabels': ['CEI-PCEA']}, {'name': 'Release analgesia by CADD SMITHS PIEB pump', 'type': 'DEVICE', 'description': 'Analgesia will be release by bolus with an automatic pump', 'armGroupLabels': ['PIEB-PCEA']}, {'name': 'Levobupivacaine', 'type': 'DRUG', 'armGroupLabels': ['CEI-PCEA', 'PIEB-PCEA']}, {'name': 'Sufentanil', 'type': 'DRUG', 'armGroupLabels': ['CEI-PCEA', 'PIEB-PCEA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': "CHU d'Estaing", 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CHU Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Estelle MORAU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Montpellier - Department of gynaecology and obstetric'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}