EpiFaith Syringe for Epidural Analgesia Learning

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new syringe, the EpiFaith® syringe, can help anesthesia residents more effectively learn to administer epidurals during childbirth. The goal is to determine if this syringe enables residents to place epidurals more easily and quickly, providing pain relief during labor. The trial compares the EpiFaith® epidural syringe with the standard glass syringe to assess which is more effective for teaching. Anesthesia residents who have placed fewer than five labor epidurals are eligible to participate. As an unphased trial, this study offers a unique opportunity to enhance medical education and patient care during childbirth.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the EpiFaith syringe is safe for epidural analgesia learning?

Research shows that the EpiFaith syringe is designed to make epidural needle insertion safer. A visual signal helps doctors place the needle more accurately, enhancing the procedure's safety and reliability.

Although specific data from human trials on its safety is lacking, the EpiFaith syringe aims to reduce risks during epidural procedures. Its presence on the market for some time suggests safe use in other situations. However, since this study doesn't pertain to a specific trial phase, detailed safety data from human trials might still be limited.12345

Why are researchers excited about this trial?

Researchers are excited about the EpiFaith syringe trial because it aims to enhance learning and precision in administering epidural analgesia. Unlike traditional glass syringes, the EpiFaith syringe might offer unique features that help medical professionals better feel the "pop" sensation when the needle enters the epidural space, potentially leading to improved accuracy and safety. This could be particularly beneficial in reducing complications and increasing the success rate of epidural procedures, which are commonly used for pain relief during childbirth and certain surgeries.

What evidence suggests that the EpiFaith syringe is effective for improving the learning curve in labor epidural techniques?

Research has shown that the EpiFaith® syringe, which participants in this trial may use, might help anesthesia residents learn to place labor epidurals more effectively. In one study, experienced providers placed epidurals on their first try 100% of the time using the EpiFaith syringe on cadavers. This finding suggests the syringe could improve accuracy and success in real-life procedures. Designed to simplify the process, the EpiFaith syringe may help beginners learn faster. Another small study showed promising results in training settings, highlighting the syringe's potential as a teaching tool. Participants in this trial will be compared to those using a control (glass) syringe to evaluate the EpiFaith syringe's effectiveness.678910

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

Anesthesiology residents with fewer than 5 prior epidural placement experiences

Exclusion Criteria

I have performed more than 5 epidural placements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Observation

Anesthesia residents perform 20 sequential labor epidural placements using either the standard technique or the EpiFaith® syringe.

Varies based on individual performance
Multiple sessions as needed

Follow-up

Participants are monitored for secondary outcomes such as incidence of inadvertent dural puncture and need for epidural catheter replacement.

Up to 5 days

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

Group I: EpiFaith syringeExperimental Treatment1 Intervention
Group II: Control (glass epidural syringe)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Citations

NCT07395622 | EpiFaith Resident Learning Curve Trial

A cumulative sum chart (CUSUM) analysis will evaluate whether the EpiFaith® syringe causes deviation from the control learning curve. Secondary ...

Feasibility of Epidural Localization Using the EpiFaith® ...

Results: The experienced provider (Provider 1) performed procedures on 16 spinal levels across 4 cadavers, achieving a 100% first-attempt success rate with no ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40773648/

Feasibility of Epidural Localization Using the EpiFaith® ...

Objective: This study aimed to evaluate the usability and accuracy of the EpiFaith® syringe for epidural access at the cervical, thoracic, and lumbar levels.

EpiFaith Smart syringe boosts epidural block training

Can this spring-loaded syringe transform how we teach epidural blocks? A pilot study from Stanford tested the EpiFaith® Smart syringe - a ...

EpiFaith Syringe for Epidural Analgesia Learning

This study aims to evaluate the impact of the EpiFaith® syringe on the learning curve of anesthesia residents for the labor epidural ...

Flat Medical Co., Ltd Shao Wei Tseng Cheif of Regulatory ...

The EpiFaith syringe is compatible to a 16-18 gauge epidural needle with Luer or NRFit connector. The user can push the plunger to increase the ...

EpiFaithTM Syringe for Epidural Space Detection

The EpiFaith syringe is an improved LOR device with the ability to warn and help physicians to achieve the safe insertion is required. EpiFaith ...

EpiFaith® Smart Syringe Mercury Medical

✓ • Intuitive Two-Hand Control: with objective visual LOR signal empowers clinicians to place needles with greater stability, accuracy, and safety. ✓ • ...

EpiFaith® Syringe - Accurate Epidural Space Localization

EpiFaith® Syringe streamlines epidural space localization with its intuitive FaithSignal visual indicator, ensuring safer procedures in clinical practice.

DEVICE: EpiFaith Syringe (04719875599019) - AccessGUDID

What MRI safety information does the labeling contain? Labeling does not contain MRI Safety Information. Device required to be labeled as containing natural ...