UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061871 |
|---|---|
| Receipt number | R000070751 |
| Scientific Title | Effect of learning support using three-dimensional reconstructed CT images for epidural anesthesia on catheter insertion time and adverse events: a single-center, prospective, randomized controlled interventional study |
| Date of disclosure of the study information | 2026/06/11 |
| Last modified on | 2026/06/11 15:42:40 |
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Basic information
Public title
Study of pre-procedure learning with 3D CT images before epidural anesthesia for surgery
Acronym
3DCT-EA study
Scientific Title
Effect of learning support using three-dimensional reconstructed CT images for epidural anesthesia on catheter insertion time and adverse events: a single-center, prospective, randomized controlled interventional study
Scientific Title:Acronym
3DCT-EA trial
Region
| Japan |
Condition
Condition
Surgical patients scheduled to undergo epidural anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of reviewing spinal anatomical information obtained from three-dimensional reconstruction of preoperative CT images before performing epidural anesthesia on the procedure time required for epidural catheter insertion, the number of puncture attempts, and puncture-related adverse events.
Preoperative assessment using three-dimensional reconstructed CT images has increasingly been applied in clinical practice in recent years; however, prospective studies evaluating its usefulness remain limited. This study is expected to provide findings that may contribute to improving the safety and efficiency of epidural anesthesia procedures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of puncture attempts required for successful epidural puncture
Key secondary outcomes
Time from skin puncture to identification of the epidural space
Proportion of cases requiring a change in the intervertebral puncture level
Proportion of cases requiring a change in the operator performing the puncture
Whether epidural catheter insertion was discontinued
Incidence of accidental dural puncture
Incidence of vascular puncture
Incidence of epidural hematoma
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pre-procedure learning using 3D reconstructed CT images (intervention group only):
Before performing epidural anesthesia, the anesthesiologist responsible for the procedure reviews the three-dimensional reconstructed CT images and evaluates or simulates the following items:
Determination of the target intervertebral level
Width and angle of the intervertebral space
Simulation of the inclination of the spinous processes and the needle insertion angle
Measurement of the estimated distance from the skin to the epidural space
Identification of potentially difficult puncture sites due to degenerative changes, such as osteophytes
Interventions/Control_2
Control group:
In the control group, the three-dimensional reconstructed CT images prepared for this study are not reviewed before the procedure. However, standard preoperative information required for routine clinical practice, such as plain radiographs and two-dimensional CT images, may be reviewed.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Key inclusion criteria
Patients scheduled to undergo surgery with epidural anesthesia at Tokyo Medical and Dental University Hospital / Institute of Science Tokyo Hospital.
Patients who have already undergone preoperative CT imaging including the spinal region, regardless of whether contrast-enhanced or non-contrast CT was performed.
Patients who provide written informed consent for participation in this study or for the use of their clinical data.
Patients aged 20 years or older at the time of consent.
Both male and female patients are eligible.
Epidural anesthesia will be performed by a senior resident in anesthesiology who has not yet obtained certification as an anesthesiology practitioner and who has provided consent to participate in this study.
The supervising anesthesiologist must be a board-certified anesthesiologist or higher, be familiar with the simulation method using SYNAPSE VINCENT, and have provided consent to participate in this study.
Key exclusion criteria
Key exclusion criteria
Patients in whom standard epidural anesthesia is considered difficult or not indicated for medical reasons.
Patients with absolute contraindications to epidural anesthesia, such as infection at the puncture site, coagulation abnormalities, or thrombocytopenia.
Patients who do not provide consent to participate in the study or who withdraw consent.
Patients who are unable to maintain the required position for epidural anesthesia.
Patients with significant preoperative neurological symptoms.
Patients undergoing emergency surgery for whom there is insufficient time to perform pre-procedure simulation using three-dimensional reconstructed CT images.
Pregnant patients.
Patients deemed unsuitable for participation in this study by the principal investigator or a sub-investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Imamura |
Organization
Institute of Science Tokyo Hospital
Division name
Anesthesiology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
imamura.s.b07b@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Imamura |
Organization
Institute of Science Tokyo Hospital
Division name
Anesthesiology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
imamura.s.b07b@m.isct.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo Hospital
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
Medical Research Ethics Committee of Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
Tel
03-5803-4547
rinri.adm@tmd.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
| 2026 | Year | 06 | Month | 11 | 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
| 2026 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070751
