Overview

ED90 of Epidural Bupivacaine for the Initiation of Labor Analgesia: A Randomized Biased Coin Sequential Allocation Trial With a Lidocaine Test Dose

Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
0
Participant gender:
Female
Summary
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"
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Brigham and Women's Hospital
Treatments:
Bupivacaine
Criteria
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