NCT05543694

ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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"

Detailed description

The primary objective of our study is to use a biased coin up-down allocation methodology 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 induction or augmentation; we hypothesize that we will be able to determine the ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses. We will be conducting this study in women who receive a prior lidocaine "test dose" used in standard clinical practice

Conditions

• Labor Pain
• Analgesia

Interventions

Type	Name	Description
DRUG	Bupivacaine Hydrochloride	Subjects will receive a dose of bupivacaine as described in the arm section of this trial

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2022-09-16
• Last updated: 2023-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study