EpiFaith Resident Learning Curve Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Anesthesiology residents with fewer than 5 prior epidural placement experiences

Disqualifiers

anesthesiology residents with more than 5 prior epidural placement experiences

Trial design

Design model

Factorial

Treatments tested in this trial

  • EpiFaith epidural syringe

    Device

    The EpiFaith syringe is an FDA-cleared epidural syringe.

  • Control (glass) syringe

    Device

    glass epidural syringe

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Control (glass epidural syringe)Experimental treatment 1 intervention
Group B: EpiFaith syringeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

success of labor epidural attempt

success 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

Time frame
time of epidural placement to 30 minutes after dosing of the epidural

Secondary outcomes

1

rating of the epidural syringe

rating of the epidural syringe loss of resistance technique

Time frame
from time of placement to immediately following placement
2

Incidence of inadvertent dural puncture

incidence of inadvertent dural puncture

Time frame
from time of epidural placement for a maximum of 5 days
3

incidence of postdural puncture headache

incidence of postdural puncture headache

Time frame
from time of epidural placement up to 5 days
4

Need for epidural catheter replacement during labor

need for epidural catheter replacement during labor

Time frame
from time of epidural placement through delivery during hospital admission

Other outcomes

Sponsors and contacts

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