UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057862 |
|---|---|
| Receipt number | R000066139 |
| Scientific Title | Application of a Spinal Ultrasound Navigation System in Spinal Anesthesia: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/05/19 |
| Last modified on | 2025/05/14 16:51:28 |
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Basic information
Public title
Application of a Spinal Ultrasound Navigation System in Spinal Anesthesia: A Randomized Controlled Trial
Acronym
Application of a Spinal Ultrasound Navigation System in Spinal Anesthesia: A Randomized Controlled Trial
Scientific Title
Application of a Spinal Ultrasound Navigation System in Spinal Anesthesia: A Randomized Controlled Trial
Scientific Title:Acronym
Application of a Spinal Ultrasound Navigation System in Spinal Anesthesia: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Elective cesarean delivery
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate whether the use of a spinal ultrasound navigation system, as an adjunct to standard spinal ultrasound, enhances the technical performance of spinal anesthesia specifically, whether it improves the success rate of spinal puncture. We will compare the spinal anesthesia performance of senior residents and obstetric anesthesiology fellows at our center. If the navigation system proves to improve puncture success even among physicians with limited ultrasound experience, it may suggest that the system enables effective and safe spinal anesthesia in settings with limited access to ultrasound training resources.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First-pass success rate of spinal puncture
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Use of the spinal ultrasound navigation system
Interventions/Control_2
Without use of the spinal ultrasound navigation system
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients aged 18 years or older undergoing elective cesarean delivery under spinal anesthesia
Key exclusion criteria
emergency surgery
history of spinal surgery
Cases in which ultrasound imaging is difficult due to skin conditions
Cases requiring thoracic epidural anesthesia
severe obesity requiring the sitting position
Cases in which the spinal ultrasound was performed by other than an obstetric anesthesia trainee
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Noguchi |
Organization
Saitama Medical Center
Division name
Obstetric anesthesia
Zip code
3500844
Address
1981 Kamoda Kawagoe city Saitama
TEL
0492283400
noguchi.shohei.521@1985.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Noguchi |
Organization
Saitama Medical Center
Division name
Obstetric anesthesia
Zip code
3500844
Address
1981, Kamoda, Kawagoe City, Saitama
TEL
0492283400
Homepage URL
noguchi.shohei.521@1985.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Saitama Medical University General Medical Center
Address
1981, Kamoda, Kawagoe City, Saitama
Tel
0492283902
smcrinri@saitama-med.ac.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 | 05 | Month | 19 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066139
