Superiority of Epidural Placement Technique Using EpiFaith Syringe

Not Applicable

Withdrawn

• Conditions: Anesthesia
• Interventions: Device: Syringe

• Registration Number: NCT04793373
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

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.

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-11
• Study Start: 2022-05-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EpiFaith® group	Syringe	Study subject will have the epidural placement with an EpiFaith® syringe.
Conventional group	Syringe	Study subject will have the epidural placement with a conventional glass syringe.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States