EpiFaith Syringe for Epidural Space Detection

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Detection by EpiFaith syringe with air	EpiFaith loss of resistance detect syringe	Fill the EpiFaith Syringe with air for LOR detection
Detection by EpiFaith syringe with saline	EpiFaith loss of resistance detect syringe	Fill the EpiFaith Syringe with saline for LOR detection

Primary Outcome Measures

Name	Time	Method
Success of Epidural Localization	30 minutes	Defined as the catheter can be inserted into epidural space successfully, no cold perception in the blocked dermatomes after the injection of anesthetic by cold sensation test, and no occurrence of inadvertent dural puncture.

Secondary Outcome Measures

Name	Time	Method
Duration of the Epidural Space Localization Procedure	30 minutes	Defined as the time from the puncture of skin to the successful insertion of the epidural catheter.
The Distance From the Skin to the Epidural Space	30 minutes	Defined as the insertion distance of the needle after locating the epidural space.
Number of Change Insertion Segment	30 minutes	Number of change insertion segment during the epidural localization procedure.
The Time to Identify the Epidural Space	30 minutes	Defined as the time of the successful localization from the first syringe attached to the Tuohy needle to the occurrence of LOR signal.
Number of Attempts	30 minutes	Defined as the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test.
Number of the Occurrence of False Positive	30 minutes	the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test