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ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia

RecruitingPhase 4Ages 18 Years - 50 YearsFemaleBrigham and Women's Hospital
NCT05543694 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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"

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📋 Eligibility rules (as published)
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
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What it tests

  • Bupivacaine Hydrochloride
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Where

1 site
Brigham and Women's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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