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Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04793373

Enrollment

Registered

2021-03-11

Start date

2022-05-15

Completion date

2026-06-30

Last updated

2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief 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.

Interventions

DEVICESyringe

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026