NCT04814537

Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques

A Trial to Determine the Optimal Bupivacaine Dose for Initiation of Labor Epidural Pain Relief

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• 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.

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.

Conditions

• Labor Pain
• Analgesia

Interventions

Type	Name	Description
DRUG	Bupivacaine Hydrochloride	Local Anesthetic Agent

Timeline

• Start date: 2021-02-25
• Primary completion: 2022-03-23
• Completion: 2022-03-23
• First posted: 2021-03-24
• Last updated: 2022-08-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study