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ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL

Labor Pain Clinical Trial

Official title:
A Trial to Determine the Optimal Bupivacaine Dose for Initiation of Labor Epidural Pain Relief With a Lidocaine Test Dose

Clinical Trial 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; we hypothesize that we 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. We also hypothesize that the post test-dose ED90 of bupivacaine is lower with a DPE technique than with a conventional epidural technique.

Clinical Trial Description

We will be conducting a randomized controlled trial with patients randomized into either an EPL or a DPE group. For the first subject in the DPE and EPL techniques, the initial dose of bupivacaine 25 mg will be used, with an endpoint being the achievement of an NRS < 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments. Hence, if the first subject does not respond successfully, the dose for the second subject will be bupivacaine 27.5 mg. If the second subject does not respond successfully, the dose for the third subject will be bupivacaine 30 mg. By contrast, if a subject responds successfully, the bupivacaine dose will be decreased to 22.5 mg with a probability of 10% and maintained with a probability of 90% (ratio 1:9). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06146842
Study type Interventional
Source Brigham and Women's Hospital
Contact Lawrence Tsen, MD
Phone 617-732-8216
Email ltsen@bwh.harvard.edu
Status Not yet recruiting
Phase N/A
Start date December 1, 2023
Completion date December 31, 2025
View Details
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