Superiority of Epidural Placement Technique Using EpiFaith Syringe

Harvard Medical School (HMS and HSDM)

Status: Withdrawn

Conditions: Anesthesia

Treatments: Device: Syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT04793373

2020P000677

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

EpiFaith® group

Experimental group

Description:

Study subject will have the epidural placement with an EpiFaith® syringe.

Treatment:

Device: Syringe

Conventional group

Active Comparator group

Description:

Study subject will have the epidural placement with a conventional glass syringe.

Treatment:

Device: Syringe