NCT04793373

Superiority of Epidural Placement Technique Using EpiFaith Syringe

Superiority of Epidural Placement Technique Using EpiFaith® Syringe Versus Conventional Glass Syringe in Laboring Paturients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Harvard Medical School (HMS and HSDM) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the impact of EpiFaith® syringe on the establishment of successful epidural labor analgesia, change of elapsed time for identification of epidural space, and learning curve of CA-1 residents.

Detailed description

We hypothesize that EpiFaith® syringe, in comparison with conventional glass syringe, will result in a similar overall success rate for catheter placement, but with a larger reduction in change of elapsed time for identification of epidural space and catheter placement of each practitioner. Moreover, we hypothesize that the cumulative learning summary curve using EpiFaith® syringe will be higher than conventional glass syringe in resident trainees, which will show the possible value of EpiFaith® syringe for teaching and learning obstetric epidural anesthesia.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DEVICE	Syringe	A syringe will be used to detect the loss of resistance and needle's entry of epidural space.

Timeline

• Start date: 2022-05-15
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2021-03-11
• Last updated: 2023-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study