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ENROLLING BY INVITATION
NCT07395622
NA

EpiFaith Resident Learning Curve Trial

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Official title: Impact of the EpiFaith® Syringe on the Learning Curve of Anesthesia Residents for the Labor Epidural Technique: A Quasi-Experimental Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2023-09-01

Completion Date

2026-06-01

Last Updated

2026-02-09

Healthy Volunteers

Yes

Interventions

DEVICE

EpiFaith epidural syringe

The EpiFaith syringe is an FDA-cleared epidural syringe.

DEVICE

Control (glass) syringe

glass epidural syringe

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States