Superiority of Epidural Placement Technique Using EpiFaith Syringe

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Anesthesia
• Intervention / Treatment: Device: Syringe

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Females 18 years of age and older at screening
• Request labor epidural analgesia
• Able to give informed consent to participate in the study
• American Society of Anesthesiologists (ASA) class Ⅰ to Ⅲ health status
• BMI ≤ 40 kg/m2

Exclusion Criteria:

• BMI > 40 kg/m2; any contraindication to neuraxial anesthesia (coagulopathy, uncorrected hypovolemia, increased intracranial pressure, or local skin infection)
• Cardiac disease history, marked spinal deformity, previous spinal surgery, or impalpable anatomical landmarks
• Any allergy to bupivacaine or fentanyl

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EpiFaith® group; Study subject will have the epidural placement with an EpiFaith® syringe.	Device: Syringe; A syringe will be used to detect the loss of resistance and needle's entry of epidural space.
Active Comparator: Conventional group; Study subject will have the epidural placement with a conventional glass syringe.	Device: Syringe; A syringe will be used to detect the loss of resistance and needle's entry of epidural space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of epidural localization	Defined as the catheter can be inserted into epidural space successfully; no occurence of inadvertent dural puncture	30 minutes

Collaborators and Investigators

• Sponsor: Harvard Medical School (HMS and HSDM)

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020P000677

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No