EpiFaith Resident Learning Curve Trial

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Epidural Analgesia; Learning Curve; Epidural Analgesia for Labour and Delivery
• Intervention / Treatment: Device: Control (glass) syringe; Device: EpiFaith epidural syringe

Detailed Description

The lumbar epidural technique for labor analgesia requires technical training and a manual skillset. A prior study evaluating anesthesia resident learning curves for a traditional labor epidural technique demonstrated a steep learning curve for the first 20 epidural placements, followed by a plateau with gradual proficiency maximized after 60 epidural placements (1). A prior study evaluated a spring-loaded epidural syringe among experienced providers (2). However, the impact of a spring-loaded epidural syringe on novice anesthesia resident learning curves is unknown. In addition, the impact of EpiFaith® use at the time of manual skill acquisition on success with subsequent traditional epidural technical skills is unknown.

The EpiFaith® syringe is FDA-cleared and has a spring-loaded piston designed to detect entry into the epidural space upon loss of resistance (LOR) as the epidural needle tip moves from the dense ligamentum flavum to the high-compliance epidural space. Performing the LOR technique using the EpiFaith® syringe, the piston within the syringe moves forward driven by spring force when a drop in pressure is detected. Piston movement within the syringe is visibly detectable with a yellow indicator in the syringe when LOR occurs. In a feasibility study of 40 labor epidural placements, 3 of 4 expert obstetric anesthesiology physicians reported the EpiFaith® syringe to be equal to superior in quality to the standard LOR syringe, with 100% success rate and no inadvertent dural punctures (3).

Evaluating the impact of the EpiFaith® syringe on learning curves of anesthesia residents with minimal prior technical experience will help inform how we approach education regarding the labor epidural technique. Steeper learning curves with faster time to proficiency may benefit both patients and supervising staff, while if no difference is determined, the use of the EpiFaith® syringe can be de-emphasized during the training period.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Anesthesiology residents with fewer than 5 prior epidural placement experiences

Exclusion Criteria:

• anesthesiology residents with more than 5 prior epidural placement experiences

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control (glass epidural syringe)	Device: Control (glass) syringe; glass epidural syringe
Experimental: EpiFaith syringe	Device: EpiFaith epidural syringe; The EpiFaith syringe is an FDA-cleared epidural syringe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success of labor epidural attempt	success of labor epidural attempt over time by each resident, with success defined as a composite requiring: Less than 3 attempts for placement; No need to re-site the epidural needle; No staff intervention; NRS 3 or less at 30 minutes post-loading epidural dose	time of epidural placement to 30 minutes after dosing of the epidural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rating of the epidural syringe	rating of the epidural syringe loss of resistance technique	from time of placement to immediately following placement
Incidence of inadvertent dural puncture	incidence of inadvertent dural puncture	from time of epidural placement for a maximum of 5 days
incidence of postdural puncture headache	incidence of postdural puncture headache	from time of epidural placement up to 5 days
Need for epidural catheter replacement during labor	need for epidural catheter replacement during labor	from time of epidural placement through delivery during hospital admission

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: labor epidural; learning curve; anesthesia residents; epidural syringe
• Additional Relevant MeSH Terms: Equipment and Supplies; Syringes
• Other Study ID Numbers: 2023P001926; 2023A006350 (Other Grant/Funding Number: Flat Medical)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No