Clinical Trial

ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL

Recruiting Phase 4
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Summary
The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required after the lidocaine test dose to achieve initial effective comfort in 90% of patients (post test-dose ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction or augmentation; the investigators hypothesize that the investigators will be able to determine the post test-dose ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses to study in a subsequent randomized trial comparing the analgesic effects of DPE vs. EPL. The investigators also hypothesize that the post test-dose ED90 of bupivacaine is lower with a DPE technique than with a conventional epidural technique.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-11-18; most recent amendment 2026-07-10.
Status change: Not Yet Recruiting → Recruiting 2025-02-06
Trial Details
NCT Number NCT06146842
Lead Sponsor Brigham and Women's Hospital
Conditions Labor Pain
Enrollment 120 participants
Start Date 2023-12-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-13