[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054108":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":34,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dural Puncture Epidural Technique","EXPERIMENTAL","Laboring women receiving the Dural Puncture Epidural (DPE) Technique, after a lidocaine \"test dose\", with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the DPE group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS \\\u003C 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.",[13],"Drug: Bupivacaine Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"Epidural Technique","ACTIVE_COMPARATOR","Laboring women receiving the Conventional Epidural Technique (EPL), after receiving a lidocaine \"test dose\" with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the EPL group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS \\\u003C 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Bupivacaine Hydrochloride","Subjects will receive a dose of bupivacaine as described in the arm section of this trial",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Lawrence C Tsen, MD","CONTACT","617-732-8216","ltsen@bwh.harvard.edu",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-71.05977,42.35843,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":48},"ltsen@zeus.bwh.harvard.edu",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Lawrence Ching Tsen","Associate Professor of Anesthesia","100054108","phase-4-ed90-of-epidural-bupivacaine-with-lidocaine-for-the-initiation-of-labor-analgesia-100054108",false,"NCT05543694","ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia","ED90 of Epidural Bupivacaine for the Initiation of Labor Analgesia: A Randomized Biased Coin Sequential Allocation Trial With a Lidocaine Test Dose","Inclusion Criteria:\n\n* Parturient with no major co-morbidities\n* Singleton, vertex gestation at term (37-42 weeks)\n* Less than or equal to 5 cm dilation\n* Desire to receive epidural labor analgesia\n* Numerical Rating Scale greater or equal to 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.\n\nExclusion Criteria:\n\n* Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)\n* Any contraindication to the administration of an epidural technique\n* History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent\n* Current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. history of uterine rupture). NB: Exception-trial of labor after cesarean delivery (TOLAC) will be eligible.\n* Evidence of anticipated fetal anomalies",true,"FEMALE","18 Years","50 Years",{"count":65,"type":66},120,"ESTIMATED","INTERVENTIONAL",[69],"PHASE4","To estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ED90) via the epidural (DPE or EPL) technique in women undergoing labor after receiving a lidocaine \"test dose\"",[72,73],"Labor Pain","Analgesia",[75,76,77,78],"Dural puncture epidural","Neuraxial Analgesia","Bupivacaine","Local Anesthetic","2026-07-10",{"date":81,"type":82},"2026-07-13","ACTUAL",{"date":84,"type":82},"2022-10-01",{"date":86,"type":66},"2027-06-30",{"name":5,"class":6},1]