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EpiFaith Resident Learning Curve Trial

NCT07395622 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-08-21

No results posted yet for this study

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.

Conditions

  • Epidural Analgesia
  • Epidural Analgesia for Labour and Delivery
  • Learning Curve

Interventions

DEVICE

EpiFaith epidural syringe

The EpiFaith syringe is an FDA-cleared epidural syringe.

DEVICE

Control (glass) syringe

glass epidural syringe

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-12-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07395622 on ClinicalTrials.gov