EpiFaith Resident Learning Curve Trial

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07395622
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • EpiFaith epidural syringe — DEVICE
    The EpiFaith syringe is an FDA-cleared epidural syringe.
  • Control (glass) syringe — DEVICE
    glass epidural syringe

Study Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
Jan 2026
Primary completion
May 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Control (glass epidural syringe)
  • Experimental: EpiFaith syringe

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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