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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07395622
Enrollment
34
Registered
2026-02-09
Start date
2023-09-01
Completion date
2026-12-01
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

labor epidural, learning curve, epidural syringe, anesthesia residents

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.

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.

Interventions

DEVICEEpiFaith epidural syringe

The EpiFaith syringe is an FDA-cleared epidural syringe.

DEVICEControl (glass) syringe

glass epidural syringe

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Anesthesiology residents with fewer than 5 prior epidural placement experiences

Exclusion criteria

* anesthesiology residents with more than 5 prior epidural placement experiences

Design outcomes

Primary

MeasureTime frameDescription
success of labor epidural attempttime of epidural placement to 30 minutes after dosing of the epiduralsuccess 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

Secondary

MeasureTime frameDescription
rating of the epidural syringefrom time of placement to immediately following placementrating of the epidural syringe loss of resistance technique
Incidence of inadvertent dural puncturefrom time of epidural placement for a maximum of 5 daysincidence of inadvertent dural puncture
incidence of postdural puncture headachefrom time of epidural placement up to 5 daysincidence of postdural puncture headache
Need for epidural catheter replacement during laborfrom time of epidural placement through delivery during hospital admissionneed for epidural catheter replacement during labor

Countries

United States

Contacts

CONTACTMichaela K Farber, MD MS
mfarber@bwh.harvard.edu617-759-1609
CONTACTNoor A Raheel, MD
nraheel@bwh.harvard.edu617-732-8251

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026