UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062172 |
|---|---|
| Receipt number | R000067714 |
| Scientific Title | The incidence of tissue coring during epidural anesthesia for labor analgesia:observational study |
| Date of disclosure of the study information | 2026/07/08 |
| Last modified on | 2026/07/08 16:55:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of biological tissue contained within the epidural Tuohy needle following epidural puncture for labor analgesia
Acronym
The incidence of tissue coring
Scientific Title
The incidence of tissue coring during epidural anesthesia for labor analgesia:observational study
Scientific Title:Acronym
The incidence of tissue coring
Region
| Japan |
Condition
Condition
Patients undergoing labour epidural analgesia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tissue coring can occur when an epidural Tuohy needle is inserted because it is a hollow needle. Although much less common than after spinal puncture, several cases of epidermoid cyst following epidural puncture have been reported. Tissue coring is considered a possible mechanism contributing to the development of these cysts.
Epidural anaesthesia is frequently performed in young women for Caesarean delivery and labour epidural analgesia. Therefore, anaesthesiologists should be aware of rare but potentially serious long-term complications such as epidermoid cysts.
The aim of this study was to determine the frequency of tissue coring during epidural puncture with a Tuohy needle and to identify the types of tissues and cells collected within the needle.
Basic objectives2
Others
Basic objectives -Others
In our previous study, we found that tissue coring occurred in approximately 60% of epidural punctures using a Tuohy needle, and we identified the types of cells collected within the needle.
However, the incidence of tissue coring during epidural puncture for labour epidural analgesia, which is commonly performed in young women who may be at risk of long-term complications such as epidermoid cysts, has not yet been investigated.
Therefore, the aim of the present study was to determine the incidence and characteristics of tissue coring during epidural puncture for labour epidural analgesia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of tissue coring
Key secondary outcomes
Participant characteristics: age
Physical characteristics: height, weight, body mass index (BMI)
Epidural puncture variables: number of puncture attempts, depth to the epidural space
Analysis of the lavage fluid from the used epidural needle: type and number of cells detected
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
Female
Key inclusion criteria
Eligibility Criteria
Patients who met the inclusion criteria, did not meet any exclusion criteria, and provided written informed consent were consecutively enrolled in the study. As this was an observational study, no randomization was performed.
Inclusion criteria: Women requesting labour epidural analgesia
Key exclusion criteria
Exclusion criteria:
Contraindications to epidural analgesia
Emergency or out-of-hours cases
Refusal to participate
Patients considered unsuitable for the study by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | Kimura |
| Last name | Kuiroiwa |
Organization
Nagano Red Cross Hospital
Division name
Department of Anesthesiology
Zip code
3808582
Address
5-22-1 Wakasato Nagano
TEL
026-226-8439
anesthesi0hanz13@yahoo.co.jp
Public contact
Name of contact person
| 1st name | KAORI |
| Middle name | |
| Last name | KUROIWA |
Organization
Nagano Red Cross Hospital
Division name
Department of Anesthesiology
Zip code
3808582
Address
5-22-1 Wakasato Nagano
TEL
0262264131
Homepage URL
anesthesi0hanz13@yahoo.co.jp
Sponsor or person
Institute
Nagano Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
personal funds
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 Bioethics Committee
Address
5-22-1 Wakasato Nagano
Tel
0262264131
anesthesi0hanz13@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
26-039
Org. issuing International ID_1
Clinical Research Ethics Committee, Hamamatsu University School of Medicine Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
浜松医科大学附属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Used epidural needle wash solution: Cell types and counts present
Subject background: Age, Height, weight, BMI,
Epidural puncture details: Information at the time of epidural puncture, Number of punctures, distance to the epidural space
Management information
Registered date
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067714
