UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054948 |
|---|---|
| Receipt number | R000056750 |
| Scientific Title | Investigation of biological tissue in the epidural needle after epidural analgesia: observational study |
| Date of disclosure of the study information | 2024/07/12 |
| Last modified on | 2025/09/29 16:44:16 |
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Basic information
Public title
Investigation of biological tissue in the epidural needle after epidural analgesia: observational study
Acronym
Investigation of the epidural needle after puncture
Scientific Title
Investigation of biological tissue in the epidural needle after epidural analgesia: observational study
Scientific Title:Acronym
Investigation of the epidural needle after puncture
Region
| Japan |
Condition
Condition
All cases where continuous epidural analgesia is indicated
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine what tissues and cells are contained within the epidural needle after epidural punctures performed on the human body.
Basic objectives2
Others
Basic objectives -Others
The next objective is to determine how likely it is that shallow tissue can be transported to deeper tissue by an epidural needle.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Finding epidermal cells or other tissue contamination inside an epidural needle punctured into the human body.
Key secondary outcomes
To determine what tissue, and to what extent, is found inside the epidural needle.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All cases where continuous epidural analgesia is indicated
Key exclusion criteria
Refusal cases and cases where epidural anaesthesia is not indicated
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | Kimura |
| Last name | Kuroiwa |
Organization
Nagano Red Cross Hospital
Division name
Department of Anesthesia
Zip code
380-8582
Address
22-1 Wakasato 5 Nagano City
TEL
026-226-4131
anesthesi0hanz13@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | Kimura |
| Last name | Kuroiwa |
Organization
Nagano Red Cross Hospital
Division name
Department of Anesthesia
Zip code
380-8582
Address
22-1 Wakasato 5 Nagano City
TEL
026-226-4131
Homepage URL
anesthesi0hanz13@yahoo.co.jp
Sponsor or person
Institute
Nagano Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
one's own expense
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
Nagano Red Cross Hospital
Address
22-1 Wakasato 5 Nagano City
Tel
023-226-4131
anesthesi0hanz13@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R-063
Org. issuing International ID_1
Nagano Red Cross Hospital Bioethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
長野県の長野赤十字病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
e-Supplement of the European Journal of Anaesthesiology
Publication of results
Published
Result
URL related to results and publications
Eur J Anaesthesiol 2025
Number of participants that the trial has enrolled
100
Results
The incidence of tissue coring was 65/100 (65%): 58 cases had anucleated squamous cells, 19 cases had nucleated squamous cells, and 9 cases had leukocytes.
Results date posted
| 2024 | Year | 07 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were adults aged 20 years or older, ASA 1-2. Patients who refused or for whom epidural anesthesia was not indicated (e.g., under anticoagulation treatment, presence of abnormal coagulation function, etc.) were excluded.
Participant flow
Patients undergoing scheduled surgery for which epidural anesthesia was indicated were included in the study after written informed consent was obtained.
The subjects were adults aged 20 years or older, ASA 1-2.
Adverse events
None
Outcome measures
Tissue coring was evaluated as having occurred if even one cell other than erythrocytes was found on examination by light microscopy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing special to mention.
Management information
Registered date
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056750
