Superiority of Epidural Placement Technique Using EpiFaith Syringe

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04793373
• Other study ID #: 2020P000677
• Status: Withdrawn
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2023
• Source: Harvard Medical School (HMS and HSDM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 ? to ? 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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Syringe
A syringe will be used to detect the loss of resistance and needle's entry of epidural space.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of epidural localization	Defined as the catheter can be inserted into epidural space successfully; no occurence of inadvertent dural puncture	30 minutes