EpiFaith Syringe for Epidural Space Detection

Identify the Epidural Space With EpiFaith Syringe in Air and Saline Based Procedures

The objective of the study is to verify the efficacies of both air and saline based procedure of EpiFaith syringe for assisting the needle localization of the epidural space.

This is a single blind, randomized study. Subjects who will receive a surgery requiring epidural anesthesia or analgesia and meet all of the study criteria will be enrolled in the study. All subjects must sign an informed consent and receive a copy of the signed and dated informed consent form prior to participation in the trial.

The study consists of 2 study visits: Visit 1 (Screening Visit) and Visit 2 (Operative Visit). After screening, eligible subject will be randomly assigned to one of the following groups: Group A: detection by EpiFaith syringe with air; Group S: detection by EpiFaith syringe with saline with a 1:1 ratio. In Visit 2, the following variables will be recorded and rated during the process of epidural space localization: Success of epidural localization, time to identify the epidural space, duration of the epidural space localization procedure, number of attempts, Number of the occurrence of false positive, the distance from the skin to the epidural space, and number of change insertion segment. Adverse events and concomitant treatments will be also recorded.

Inclusion Criteria:

• 20 years and older
• Surgery requiring epidural anesthesia or analgesia
• ASA Physical Status 1 to 3

Exclusion Criteria:

• Bleeding and clotting disorders

  • Platelet count < 100,000 / mm3
  • International normalized ratio (INR) > 1.5

• History of peripheral neuropathy

• Neuromuscular or neuropsychiatric disease

• Marked spinal deformities or a history of spinal instrumentation

• Systemic infection

• Skin infection at the injection site

• Significant heart failure, e.g. New York Heart Association (NYHA) Functional Classification 3 or 4