[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05543694":3,"trial-entities:NCT05543694":98,"trial-summary:NCT05543694":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":65,"locations":67,"central_contacts":82,"overall_officials":85,"references":86,"see_also_links":97},"NCT05543694","2022P002226","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","RECRUITING","2027-06-30","2026-07","2026-07-13","2022-10-01","Brigham and Women's Hospital","OTHER",false,"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\"","The primary objective of our study is to use a biased coin up-down allocation methodology 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 induction or augmentation; we hypothesize that we will be able to determine the ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses. We will be conducting this study in women who receive a prior lidocaine \"test dose\" used in standard clinical practice",[19,20],"Labor Pain","Analgesia",[22,23,24,25],"Dural puncture epidural","Neuraxial Analgesia","Bupivacaine","Local Anesthetic","INTERVENTIONAL","TREATMENT",[29],"PHASE4",{"count":31,"type":32},120,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Bupivacaine Hydrochloride","Subjects will receive a dose of bupivacaine as described in the arm section of this trial",[39,40],"Dural Puncture Epidural Technique","Epidural Technique",[42],{"measure":43,"description":44,"timeFrame":45},"Verbal Numerical Pain Rating Score","(0-10, with higher scores meaning more pain); goal with analgesia is \\\u003C 3\u002F10","30 minutes",[],"FEMALE","18 Years","50 Years",true,{"inclusion":52,"exclusion":58,"raw_text":64},[53,54,55,56,57],"Parturient with no major co-morbidities","Singleton, vertex gestation at term (37-42 weeks)","Less than or equal to 5 cm dilation","Desire to receive epidural labor analgesia","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.",[59,60,61,62,63],"Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)","Any contraindication to the administration of an epidural technique","History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent","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.","Evidence of anticipated fetal anomalies","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",[66],"ADULT",[68],{"facility":13,"status":8,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":79},"Boston","Massachusetts","02115","United States",[74],{"name":75,"role":76,"phone":77,"email":78},"Lawrence C Tsen, MD","CONTACT","617-732-8216","ltsen@zeus.bwh.harvard.edu",{"lat":80,"lon":81},42.35843,-71.05977,[83],{"name":75,"role":76,"phone":77,"email":84},"ltsen@bwh.harvard.edu",[],[87,91,94],{"pmid":88,"type":89,"citation":90},"20613484","BACKGROUND","Ngan Kee WD, Ng FF, Khaw KS, Lee A, Gin T. Determination and comparison of graded dose-response curves for epidural bupivacaine and ropivacaine for analgesia in laboring nulliparous women. Anesthesiology. 2010 Aug;113(2):445-53. doi: 10.1097\u002FALN.0b013e3181bdf9da.",{"pmid":92,"type":89,"citation":93},"14639153","Benhamou D, Ghosh C, Mercier FJ. A randomized sequential allocation study to determine the minimum effective analgesic concentration of levobupivacaine and ropivacaine in patients receiving epidural analgesia for labor. Anesthesiology. 2003 Dec;99(6):1383-6. doi: 10.1097\u002F00000542-200312000-00022.",{"pmid":95,"type":89,"citation":96},"28067707","Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213\u002FANE.0000000000001798.",[],{"nct_id":4,"conditions":99,"biomarkers":100},[19],[],{"nct_id":4,"found":50,"summary":102,"prompt_version":112},{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This interventional study plans to enroll 120 women. It uses a special method called a biased coin up-down allocation to determine bupivacaine doses.","completed","Epidural Bupivacaine with Lidocaine for Labor Pain","This study is looking for women aged 18 to 50 who are in labor and want an epidural for pain relief. You would need to be 37-42 weeks pregnant with a single baby, have no major health problems, and be less than 5 cm dilated with a pain score of 5 or higher. The study is testing different doses of bupivacaine hydrochloride, a medication used in epidurals, after you receive a standard lidocaine \"test dose.\" The goal is to find the dose of bupivacaine that effectively relieves pain for 90% of patients. The study is currently recruiting 120 participants.","Your pain will be measured at 30 minutes after the epidural is initiated.",99,"You would receive doses of bupivacaine as part of your epidural. Your pain level will be measured 30 minutes after the epidural is started.","Not stated in the trial record.",[36],"v2"]