Comparison of the Epifaith® Syringe With the Plastic Syringe

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Epidural; Anesthesia, Headache; Analgesia

Treatments: Procedure: Labor analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06085027

202301331A3

Details and patient eligibility

About

The goal of this clinical trial is to compare the efficiency of identifying epidural space with either the Epifaith® syringe or the plastic syringe in parturients. The main questions it aims to answer are:

• Whether it consume less time identifying epidural space with the Epifaith® syringe
• Whether the usage of the Epifaith® syringe decrease the complication rate and failure of labor analgesia Participants will receive labor analgesia either with the Epifaith® syringe or the plastic syringe conducted by experienced resident doctors.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA II to III
• Require labor analgesia
• Has submitted inform consent

Exclusion criteria

• ASA IV or above
• Coagulopathy
• Spinal deformity
• Neurological, psychological, cardiopulmonary disorder
• Active liver or kidney injury

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

The Epifaith® syringe

Experimental group

Treatment:

Procedure: Labor analgesia

The plastic syringe

Active Comparator group

Treatment:

Procedure: Labor analgesia