UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058904 |
|---|---|
| Receipt number | R000067331 |
| Scientific Title | Feasibility of Complete Real-Time Ultrasound-Guided Thoracic Epidural Puncture Using an Automatic LOR Detection Syringe: A Retrospective Observational Feasibility Study |
| Date of disclosure of the study information | 2025/08/29 |
| Last modified on | 2025/08/26 23:14:14 |
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Basic information
Public title
Feasibility of Complete Real-Time Ultrasound-Guided Thoracic Epidural Puncture Using an Automatic LOR Detection Syringe: A Retrospective Observational Feasibility Study
Acronym
Feasibility of Real-Time Ultrasound-Guided Thoracic Epidural
Scientific Title
Feasibility of Complete Real-Time Ultrasound-Guided Thoracic Epidural Puncture Using an Automatic LOR Detection Syringe: A Retrospective Observational Feasibility Study
Scientific Title:Acronym
Feasibility of Real-Time Ultrasound-Guided Thoracic Epidural
Region
| Japan |
Condition
Condition
patients who underwent abdominal surgery with thoracic epidural anesthesia performed by real-time ultrasound-guided thoracic epidural puncture
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focused on the technical feasibility of completely real-time ultrasound-guided thoracic epidural puncture using a syringe with an automatic resistance disappearance function, with particular emphasis on whether the moment of resistance disappearance (LOR) could be accurately visualized in real time under ultrasound guidance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the primary outcome was defined as successful real-time ultrasound visualization of the exact moment of LOR, regardless of the number of passes or puncture attempts.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We included all consecutive patients who underwent abdominal surgery and an attempt of real-time US-guided TEP during the study period.
Key exclusion criteria
The only exclusion criterion was puncture across the Th12/L1 level.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shosaburo |
| Middle name | |
| Last name | Jotaki |
Organization
Omuta city hospital
Division name
Department of anesthesiology
Zip code
836-8567
Address
2-19-1 Takarazaka-machi, Omuta, Fukuoka
TEL
0944-53-1061
sjsjsj1678@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shosaburo |
| Middle name | |
| Last name | Jotaki |
Organization
Omuta city hospital
Division name
Department of anesthesiology
Zip code
836-8567
Address
2-19-1 Takarazaka-machi, Omuta, Fukuoka
TEL
0944-53-1061
Homepage URL
sjsjsj1678@yahoo.co.jp
Sponsor or person
Institute
Omuta city hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omuta City Hospital Ethics Committee Clinical Research Specialist Committee
Address
2-19-1 Takarazaka-machi, Omuta, Fukuoka
Tel
0944-53-1061
crc@ghp.omuta.fukuoka.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
67
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-center retrospective observational study.
Management information
Registered date
| 2025 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067331
