Actively Recruiting

Phase 4
FEMALE
Healthy Volunteers
NCT06146842

ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL

Led by Brigham and Women's Hospital · Updated on 2025-02-10

120

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL

Who Can Participate

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant woman in labor with no major health problems
  • Single baby in head-down position at term (37 to 42 weeks gestation)
  • Cervical dilation of 5 centimeters or less
  • Desire to receive epidural labor pain relief
  • Pain rating of 5 or higher on a 0-10 scale at time of epidural request
Not Eligible

You will not qualify if you...

  • Presence or history of significant diseases or pregnancy complications such as preeclampsia or gestational diabetes
  • Any reason that prevents safe epidural use, like low platelet count or use of blood thinners
  • Known allergy or unusual reaction to amide local anesthetics
  • Expected problems with the baby, including fetal anomalies or growth issues like IUGR, low or excessive amniotic fluid

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

L

Lawrence Tsen, MD

CONTACT

A

Ayumi Maeda, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL | DecenTrialz