[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647512":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":31,"locations":31,"responsibleParty":39,"collaborators":31,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":31,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":31,"enrollmentInfo":50,"targetDuration":31,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":31,"overallStatus":60,"whyStopped":31,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":31},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"DPEA 27G","EXPERIMENTAL","Patients in the DPEA 27G group will receive an intentional dural puncture with a 27 Gauge Whitacre spinal needle, using the needle-through-needle technique (the epidural space will be identified using a 18 Gauge Tuohy needle).",[13],"Device: Dural Puncture Epidural Analgesia 27G",{"label":15,"type":10,"description":16,"interventionNames":17},"DPEA 25G","Patients in the DPEA 25G group will receive an intentional dural puncture with a 25 Gauge Whitacre spinal needle, using the needle-through-needle technique (the epidural space will be identified using a 18 Gauge Tuohy needle).",[18],"Device: Dural Puncture Epidural Analgesia 25G",{"label":20,"type":21,"description":22,"interventionNames":23},"Epidural","ACTIVE_COMPARATOR","Patients in the Epidural group will receive a conventional epidural (the epidural space will be identified using a 18 Gauge Tuohy needle).",[24],"Device: Conventional epidural",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Dural Puncture Epidural Analgesia 27G","Patients will receive an intentional dural puncture with a 27 Gauge Whitacre spinal needle, using the needle-through-needle technique.",[9],null,{"type":27,"name":33,"description":29,"armGroupLabels":34,"otherNames":31},"Dural Puncture Epidural Analgesia 25G",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":31},"Conventional epidural","Patients will receive a conventional epidural (the epidural space will be identified using a 18 Gauge Tuohy needle).",[20],{"type":40,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100647512","two-different-sized-spinal-needles-dpe-vs-conventional-epidural-technique-100647512",false,"NCT07708909","Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique","Dural Pubcture Epidural Performed With Two Different Sized Spinal Needles vs Conventional Epidural Technique: a Triple Randomized Comparison to Evaluate Quality of Labor Analgesia","Inclusion Criteria:\n\n* nulliparous women\n* between the 36th and 42nd gestational week\n* active labor and with a cervical dilation ≤ 5 cm\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* ASA status \\> 2\n* patient's refusal\n* known fetal pathologies\n* contraindications to neuraxial techniques\n* uterine anomalies or previous uterine surgery\n* BMI ≥ 35\n* twinning and fetal malpresentation (non cephalic).","FEMALE","10 Years",{"count":51,"type":52},240,"ESTIMATED","INTERVENTIONAL",[55],"NA","DPEA (Dural Puncture Epidural Analgesia) is an alternative to the conventional epidural analgesia and technically a Combined Spinal Epidural (CSE) with omission of intrathecal drugs administration.\n\nTo date, literature has proved several advantages of the DPEA techniquecompared to conventional epidural.\n\nHowever, these advantages are supposed to be limited to the use of 25 Gauge spinal needles.\n\nThe aim of this project is to compare the quality of analgesia achieved after a DPEA technique performed with a 25 Gauge spinal needle versus a 27 Gauge spinal needle versus a conventional epidural, with a PIEB pump installed for analgesia maintenance.\n\nThe Primary outcome will be the quality of analgesia, defined as the area under the curve (AUC) of the Numeric Pain Rating Scale (NPRS 100-0) ≤ 30 measured throughout labor and divided by labor duration (TWA-NPRS).\n\n240 nulliparous women between the 36th and 42nd gestational week in active labor and with a cervical dilation ≤ 5 cm will be randomized according to a computer-generated random number sequence to receive a DPEA with a 25 Gauge spinal needle, a DPEA with a 27 Gauge spinal needle, or a conventional epidural.",[58,59],"Labor Pain","Dural Puncture Epidural Technique","NOT_YET_RECRUITING","2026-07-27",{"date":63,"type":64},"2026-07-29","ACTUAL",{"date":66,"type":52},"2026-08-01",{"date":68,"type":52},"2027-12-31",{"name":5,"class":6}]