Viewing Study NCT06146842



Ignite Creation Date: 2024-05-06 @ 7:48 PM
Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06146842
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-11-27
First Post: 2023-11-18

Brief Title: ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL
Sponsor: Brigham and Womens Hospital
Organization: Brigham and Womens Hospital

Study Overview

Official Title: A Trial to Determine the Optimal Bupivacaine Dose for Initiation of Labor Epidural Pain Relief With a Lidocaine Test Dose
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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 25 mg 1 mL increments Hence if the first subject does not respond successfully the dose for the second subject will be bupivacaine 275 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 225 mg with a probability of 10 and maintained with a probability of 90 ratio 19

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None