Clinical Trial

EpiFaith Resident Learning Curve Trial

Enrolling by Invitation
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Record status
This record was last updated February 9, 2026 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to evaluate the impact of the EpiFaith® syringe on the learning curve of anesthesia residents for the labor epidural technique. Anesthesia residents with prior experience placing \< 5 labor epidurals will be enrolled. Their performance of 20 sequential labor epidural placements with either standard technique with a beveled glass syringe or the EpiFaith® syringe will be observed. Successful epidural placement over time with sequential epidural placement attempts will be measured between groups. The primary outcome will be rate of successful epidural placement. Success will be defined as a composite of 4 criteria: maximum 3 attempts for placement; no need to re-site at a different level; no required intervention by the supervising attending anesthesiologist; and adequate analgesia with a visual analog score (VAS) \<3 at 30 minutes. We hypothesize that use of the EpiFaith® syringe will enable a faster learning curve for successful epidural placement. A cumulative sum chart (CUSUM) analysis will evaluate whether the EpiFaith® syringe causes deviation from the control learning curve. Secondary outcomes will include rate of inadvertent dural puncture and epidural replacement rate.
Trial Details
NCT Number NCT07395622
Lead Sponsor Brigham and Women's Hospital
Conditions Epidural Analgesia, Epidural Analgesia for Labour and Delivery, Learning Curve
Enrollment 34 participants
Start Date 2023-09-01
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-09