N/A
N=60
EpiFaith Syringe for Epidural Space Detection
Epidural Localization
Bottom Line
View on ClinicalTrials.gov: NCT03983109 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Success of Epidural Localization — 18; 30; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EpiFaith loss of resistance detect syringe (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Flat Medical Co., Ltd
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success of Epidural Localization |
18; 30; 0; 0 | — |
| SECONDARY The Time to Identify the Epidural Space |
231; 130 | — |
| SECONDARY Duration of the Epidural Space Localization Procedure |
309; 194 | — |
| SECONDARY Number of Attempts |
2; 1 | — |
| SECONDARY The Distance From the Skin to the Epidural Space |
63.3; 65.1 | — |
| SECONDARY Number of Change Insertion Segment |
0; 0 | — |
| SECONDARY Number of the Occurrence of False Positive |
0; 0 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03983109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.