[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554068":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":62,"collaborators":40,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":40,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":40,"maxAge":40,"enrollmentInfo":73,"targetDuration":40,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":48,"whyStopped":40,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Holy Family Hospital, Nazareth, Israel","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"study group","ACTIVE_COMPARATOR","Epidural analgesia will be maintained by receiving programmed intermittent 10ml bolus of 0.1% Bupivacaine and 2microgram\\\\ml Fentanyl every one hour, until the delivery is completed, and lacerations are sutured.",[13],"Drug: programmed intermittent Bolus epidural analgesia",{"label":15,"type":10,"description":16,"interventionNames":17},"control group","Epidural analgesia will be maintained by receiving 10ml\\\\h continuous infusion of 0.1% Bupivacaine and 2microgram\\\\ml Fentanyl until the delivery is completed, and lacerations are sutured.",[18],"Drug: continuous epidural infusion",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","programmed intermittent Bolus epidural analgesia","About 30 minutes after the end of the epidural and administration of the loading dose, the woman will be asked to report her pain level. If the VAS score \\\u003C30, the woman will receive the study group protocol for pain maintenance, i.e., a programmed intermittent bolus of 10 ml of 0.1% bupivacaine and 2 μg\u002Fml fentanyl every hour until the completion of labor and suturing of the incision. The participant can add to herself 5 ml of the same solution of Bupivacaine and Fentanyl every 30 minutes. The maximum dose that the parturient is allowed to receive is 20 ml for one hour.\n\nIf a breakthrough pain appears during labor, a bolus of 10 ml of anesthetic solution with the same concentration will be added.\n\nParticipants with a VAS score \\>30 after 30 minutes of the loading dose will be asked to perform a new epidural (if it was decided that the epidural failed) otherwise her data will not be collected for the final analysis of the study.",[9],[26],"Bupivacaine + Fentanyl",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"continuous epidural infusion","About 30 minutes after the end of the epidural and administration of the loading dose, the woman will be asked to report her pain level. If the VAS score \\\u003C30, the woman will receive the control group protocol for pain maintenance, i.e., 0.1% Bupivacaine and 2 μg\u002Fml fentanyl as a continuous infusion per one hour, until the delivery is completed, and laceration is sutured. The participant can add to herself 5 ml of the same solution of Bupivacaine and Fentanyl every 30 minutes. The maximum dose that the parturient is allowed to receive is 20 ml for one hour.\n\nIf a breakthrough pain appears during labor, a bolus of 10 ml of anesthetic solution with the same concentration will be added.\n\nParticipants with a VAS score \\>30 after 30 minutes of the loading dose will be asked to perform a new epidural (if it was decided that the epidural failed) otherwise her data will not be collected for the final analysis of the study.",[15],[26],[33],{"name":34,"affiliation":5,"role":35},"Raed Salim, MD","STUDY_CHAIR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","+972544986960",null,"r.salim@hfhosp.org",{"name":43,"role":38,"phone":39,"phoneExt":40,"email":44},"Asmaa Masri Esmail, MD","Asmaa.Masri94@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":40,"zip":40,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Holy Family Hospital","RECRUITING","Nazareth","Israel","IL",{"type":53,"coordinates":54},"Point",[55,56],35.29719,32.70087,{"lat":56,"lon":55},[59,60],{"name":34,"role":38,"phone":40,"phoneExt":40,"email":41},{"name":43,"role":61,"phone":40,"phoneExt":40,"email":40},"PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":34,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"head of obstetrics and gynecology department","100554068","pieb-compared-with-cei-on-breakthrough-pain-in-nulliparous-women-100554068",false,"NCT06494280","PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women","Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Nulliparous Women. A Randomized Controlled Trial","Inclusion Criteria:\n\n* Nulliparous women\n* Term pregnancy\n* Singleton\n* Vertex presentation\n* Latent phase (cervical dilatation \\\u003C6 cm)\n* Epidural analgesia request\n* Visual Analogue Scale score \\> 40\n\nExclusion Criteria:\n\n* Estimated fetal weight \\> 4 kg\n* Intra uterine fetal death\n* Drug sensitivity\n* Anomalous fetus\n* Contraindication for epidural analgesia",true,"FEMALE",{"count":74,"type":75},240,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this randomized controlled trial is to examine the impact of programmed intermittent bolus epidural analgesia technique on the incidence of breakthrough pain during labor in nulliparous women compared to continuous epidural infusion.\n\nNulliparous women will randomly be divided during labor into two groups; study group will receive mix of Bupivacaine and fentanyl once (bolus) every 60 minutes; the control group will receive continuously the same dose during an hour, until delivery.",[81],"Breakthrough Pain",[83,84,85,86,87,88,89],"Nullipara","Term pregnancy","Singleton","Vertex presentation","Latent phase","Maternal request for epidural","Visual analogue scale > 4","2026-04-07",{"date":92,"type":93},"2026-04-13","ACTUAL",{"date":95,"type":93},"2024-09-10",{"date":97,"type":75},"2026-12",{"name":5,"class":6},1]