EpiFaith Syringe for Epidural Analgesia Learning
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for anesthesiology residents who have done fewer than 5 epidural placements. It's designed to see if the EpiFaith syringe helps them learn how to do labor epidurals faster and more successfully compared to using a standard glass syringe.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Training and Observation
Anesthesia residents perform 20 sequential labor epidural placements using either the standard technique or the EpiFaith® syringe.
Follow-up
Participants are monitored for secondary outcomes such as incidence of inadvertent dural puncture and need for epidural catheter replacement.
What Are the Treatments Tested in This Trial?
Interventions
- Control (glass) syringe
- EpiFaith epidural syringe
Trial Overview
The study compares two methods of learning epidural placement: one with a new tool called the EpiFaith syringe, and the other with a traditional glass syringe. Residents will perform 20 labor epidurals, and their success rates will be tracked over time.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
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