Epidural Localization
Conditions
Keywords
EpiFaith, Epidural localization
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.
Interventions
DEVICEEpiFaith loss of resistance detect syringe
An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.
Sponsors
Flat Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 Change Insertion Segment | 30 minutes | Number of change insertion segment during the epidural localization procedure. |
| 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 |
| The Distance From the Skin to the Epidural Space | 30 minutes | Defined as the insertion distance of the needle after locating the epidural space. |
Countries
Taiwan
Participant flow
Pre-assignment details
Subjects will be randomized to one of the two groups (A group - EpiFaith syringe with air or S group - EpiFaith syringe with saline) at the ratio of 1:1. The randomization method will result in sealed, opaque envelopes containing the computer- generated, random assignment. Randomization will occur in blocks so that blocks of equal numbers of subjects will be used to avoid potential runs of assignments.
Participants by arm
| Arm | Count |
|---|---|
| Detection by EpiFaith Syringe With Air Fill the EpiFaith Syringe with air for LOR detection | 30 |
| Detection by EpiFaith Syringe With Saline Fill the EpiFaith Syringe with saline for LOR detection | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Operational Hurdles Linked to Usage Methodologies | 12 | 0 |
Baseline characteristics
| Characteristic | Detection by EpiFaith Syringe With Air | Detection by EpiFaith Syringe With Saline | Total |
|---|---|---|---|
| Age, Continuous | 57.83 years STANDARD_DEVIATION 10.47 | 61.13 years STANDARD_DEVIATION 12.24 | 59.48 years STANDARD_DEVIATION 11.32 |
| ASA Physical Status Status 1 | 3 Participants | 3 Participants | 6 Participants |
| ASA Physical Status Status 2 | 21 Participants | 21 Participants | 42 Participants |
| ASA Physical Status Status 3 | 6 Participants | 6 Participants | 12 Participants |
| BMI | 24.57 kg/m^2 STANDARD_DEVIATION 4.31 | 23.82 kg/m^2 STANDARD_DEVIATION 3.6 | 24.14 kg/m^2 STANDARD_DEVIATION 3.92 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 13 Participants | 32 Participants |
| Sex: Female, Male Male | 11 Participants | 17 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Detection by EpiFaith Syringe With Air | Success of Epidural Localization | Success of epidural localization | 18 Participants |
| Detection by EpiFaith Syringe With Air | Success of Epidural Localization | Failure of epidural localization | 0 Participants |
| Detection by EpiFaith Syringe With Saline | Success of Epidural Localization | Success of epidural localization | 30 Participants |
| Detection by EpiFaith Syringe With Saline | Success of Epidural Localization | Failure of epidural localization | 0 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Detection by EpiFaith Syringe With Air | Duration of the Epidural Space Localization Procedure | 309 secs | Standard Deviation 276 |
| Detection by EpiFaith Syringe With Saline | Duration of the Epidural Space Localization Procedure | 194 secs | Standard Deviation 182 |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Detection by EpiFaith Syringe With Air | Number of Attempts | 2 attempts |
| Detection by EpiFaith Syringe With Saline | Number of Attempts | 1 attempts |
Secondary
Number of Change Insertion Segment
Number of change insertion segment during the epidural localization procedure.
Time frame: 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Detection by EpiFaith Syringe With Air | Number of Change Insertion Segment | 0 segments |
| Detection by EpiFaith Syringe With Saline | Number of Change Insertion Segment | 0 segments |
Secondary
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
Time frame: 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Detection by EpiFaith Syringe With Air | Number of the Occurrence of False Positive | 0 occurrences |
| Detection by EpiFaith Syringe With Saline | Number of the Occurrence of False Positive | 0 occurrences |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Detection by EpiFaith Syringe With Air | The Distance From the Skin to the Epidural Space | 63.3 mm | Standard Deviation 10.4 |
| Detection by EpiFaith Syringe With Saline | The Distance From the Skin to the Epidural Space | 65.1 mm | Standard Deviation 9.2 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Detection by EpiFaith Syringe With Air | The Time to Identify the Epidural Space | 231 secs | Standard Deviation 273 |
| Detection by EpiFaith Syringe With Saline | The Time to Identify the Epidural Space | 130 secs | Standard Deviation 169 |