EpiFaith Syringe for Epidural Space Detection

Study Overview
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Brief Summary
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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.

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

Conditions
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Epidural Localization

Intervention / Treatment
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* Device: EpiFaith loss of resistance detect syringe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Detection by EpiFaith syringe with air<br> | Device: EpiFaith loss of resistance detect syringe<br>* An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.<br>|
| Experimental: Detection by EpiFaith syringe with saline<br> | Device: EpiFaith loss of resistance detect syringe<br>* An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 30 minutes | 
| The distance from the skin to the epidural space |  | 30 minutes | 
| Number of change insertion segment |  | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EpiFaith, Epidural localization