Recruiting

EpiFaith® Syringe

Sponsor:

Brigham and Women's Hospital

Code:

NCT07395622

Conditions

Epidural Analgesia

Epidural Analgesia for Labour and Delivery

Learning Curve

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

EpiFaith epidural syringe

Control (glass) syringe

Study Details

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

Study ID

NCT07395622

Start date

Sep 1, 2023

Status verified date

Aug, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

34 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Control (glass epidural syringe)

experimental: EpiFaith syringe

Interventions

EpiFaith epidural syringe

The EpiFaith syringe is an FDA-cleared epidural syringe.

Control (glass) syringe

glass epidural syringe

Primary outcome measure

  • success of labor epidural attempt [ Time Frame: time of epidural placement to 30 minutes after dosing of the epidural ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michaela K Farber, MD MS

617-759-1609mfarber@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • labor epidural
  • learning curve
  • epidural syringe
  • anesthesia residents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-08-21.