EpiFaith Resident Learning Curve Trial

NCT07395622 | Enrolling By Invitation FDA Device

• 2 other identifiers: 2023P0019262023A006350
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

labor epidural; learning curve; epidural syringe; anesthesia residents

Outcome Measures

Primary Outcomes (1)

• success of labor epidural attempt

  success of labor epidural attempt over time by each resident, with success defined as a composite requiring: 1. Less than 3 attempts for placement 2. No need to re-site the epidural needle 3. No staff intervention 4. NRS 3 or less at 30 minutes post-loading epidural dose

  time of epidural placement to 30 minutes after dosing of the epidural

Secondary Outcomes (4)

• rating of the epidural syringe

  from time of placement to immediately following placement

• Incidence of inadvertent dural puncture

  from time of epidural placement for a maximum of 5 days

• incidence of postdural puncture headache

  from time of epidural placement up to 5 days

• Need for epidural catheter replacement during labor

  from time of epidural placement through delivery during hospital admission

Study Arms (2)

Control (glass epidural syringe)

EXPERIMENTAL

Device: Control (glass) syringe

EpiFaith syringe

EXPERIMENTAL

Device: EpiFaith epidural syringe

Interventions

EpiFaith epidural syringe DEVICE

The EpiFaith syringe is an FDA-cleared epidural syringe.

EpiFaith syringe

Control (glass) syringe DEVICE

glass epidural syringe

Control (glass epidural syringe)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anesthesiology residents with fewer than 5 prior epidural placement experiences

You may not qualify if:

• anesthesiology residents with more than 5 prior epidural placement experiences

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Syringes

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Obstetric Anesthesiology, Mass General Brigham

Model Details: The study will be conducted as a quasi-eperimental trial. Study subjects will be assigned to one of the two groups for their epidural placement based on the month of their rotation, with alternating months: 1) EpiFaith® Group, in which EpiFaith® syringe is used; or 2) Control Group in which a conventional glass syringe is used

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: February 9, 2026
• Study Start: September 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)