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 volunteersQualifiers
Anesthesiology residents with fewer than 5 prior epidural placement experiences
Disqualifiers
anesthesiology residents with more than 5 prior epidural placement experiences
Trial design
Factorial
Treatments tested in this trial
EpiFaith epidural syringe
DeviceThe EpiFaith syringe is an FDA-cleared epidural syringe.
Control (glass) syringe
Deviceglass epidural syringe
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
rating of the epidural syringe
rating of the epidural syringe loss of resistance technique
Incidence of inadvertent dural puncture
incidence of inadvertent dural puncture
incidence of postdural puncture headache
incidence of postdural puncture headache
Need for epidural catheter replacement during labor
need for epidural catheter replacement during labor
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