Who is eligible for clinical trial NCT05543694?

Participants must meet protocol criteria for Labor Pain. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05543694 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-10

ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia (NCT05543694)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Brigham and Women's Hospital

🩺 Plain-English Summary (8th-Grade Level)

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"

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (6 items).

Location: Brigham and Women's Hospital — Boston, Massachusetts

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Brigham and Women's Hospital — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗