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ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia
RecruitingPhase 4Healthy volunteers welcome
ED90 of Epidural Bupivacaine for the Initiation of Labor Analgesia: A Randomized Biased Coin Sequential Allocation Trial With a Lidocaine Test Dose
Who can join
Ages 18 to 50 · Women · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
About the study
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"
What is being tested
- Bupivacaine Hydrochloride (drug)
Sponsor: Brigham and Women's Hospital · Participants: 120 · Started: Oct 1, 2022
Contact the study team
- Lawrence C Tsen, MD · Phone: 617-732-8216
Official record on ClinicalTrials.gov — NCT05543694
Locations in the U.S.
| Massachusetts | Brigham and Women's Hospital, Boston |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.