RecruitingPhase 4NCT06146842

ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL

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

Sponsor

Brigham and Women's Hospital

Enrollment

120 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Labor Pain

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.

Eligibility

Sex: FEMALE

Inclusion Criteria5

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 than or equal to 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.

Exclusion Criteria4

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 (e.g., thrombocytopenia, antiplatelet meds).
History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
Evidence of anticipated fetal complications (i.e., fetal anomalies, IUGR (Intrauterine Growth Restriction), oligohydramnios, polyhydramnios)

Interested in this trial?

Get notified about updates and connect with the research team.