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RECRUITING
NCT06146842
PHASE4

ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Official title: A Trial to Determine the Optimal Bupivacaine Dose for Initiation of Labor Epidural Pain Relief with a Lidocaine Test Dose

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-12-01

Completion Date

2026-01-31

Last Updated

2025-02-10

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Bupivacaine Hydrochloride

Each subject will receive allocated dose of bupivacaine

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States