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NCT06146842 · ClinicalTrials.gov registry record · Phase 4
ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL
A Phase 4 study of Labor Pain, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06146842 is a Phase 4 study of Labor Pain that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 120 participants, below the 195-participant average among 14 other Labor Pain trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06146842, a Phase 4 study of Labor Pain, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Bupivacaine Hydrochloride
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2026-01-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06146842
The ClinicalTrials.gov registry entry for NCT06146842 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 195-participant average among 14 other Labor Pain trials with a reported enrollment target (38% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Labor Pain appearing as the primary indexed condition, and to 1 intervention - of which Bupivacaine Hydrochloride is the first listed.
NCT06146842 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06146842 about?
NCT06146842 is a clinical study titled "ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL". 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 undergoi...
What is the current status of trial NCT06146842?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2023-12-01. Estimated completion is 2026-01-31.
What conditions does trial NCT06146842 study?
This clinical trial studies the following conditions: Labor Pain.
What interventions are being tested in trial NCT06146842?
The interventions under investigation include: Bupivacaine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT06146842?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06146842 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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