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RECRUITING Not applicable ClinicalTrials.gov

EpiFaith Resident Learning Curve Trial

Sponsor: Brigham and Women's Hospital • ClinicalTrials.gov ID: NCT07395622

Registry updated: 2026-08-21
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Description

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.

Interventions

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

Eligibility criteria

Inclusion Criteria: * Anesthesiology residents with fewer than 5 prior epidural placement experiences Exclusion Criteria: * anesthesiology residents with more than 5 prior epidural placement experiences

Conditions

Epidural Analgesia Epidural Analgesia for Labour and Delivery Learning Curve

Locations

  • Brigham and Women's Hospital — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record