EpiFaith Syringe for Epidural Space Detection

Flat Medical Co., Ltd60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Epidural Localization

Interventions

EpiFaith loss of resistance detect syringeDEVICE

An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Taipei Veterans General Hospital

Taipei, Please Select, Taiwan

Outcomes

Primary Outcomes

Success of Epidural Localization

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.

Time frame: 30 minutes

Secondary Outcomes

The Time to Identify the Epidural Space

Defined as the time of the successful localization from the first syringe attached to the Tuohy needle to the occurrence of LOR signal.

Time frame: 30 minutes

Duration of the Epidural Space Localization Procedure

Defined as the time from the puncture of skin to the successful insertion of the epidural catheter.

Time frame: 30 minutes

Number of Attempts

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.

Time frame: 30 minutes

The Distance From the Skin to the Epidural Space

Defined as the insertion distance of the needle after locating the epidural space.

Time frame: 30 minutes

Number of Change Insertion Segment

Number of change insertion segment during the epidural localization procedure.

Time frame: 30 minutes

Number of the Occurrence of False Positive

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

Data from ClinicalTrials.gov

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