UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062063 |
|---|---|
| Receipt number | R000071015 |
| Scientific Title | Investigation of Catheter Displacement and Bleeding at the Skin Insertion Site of Epidural Catheters |
| Date of disclosure of the study information | 2026/06/27 |
| Last modified on | 2026/06/26 11:05:19 |
* 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
Assessment of catheter displacement at the insertion site and bleeding status following the insertion of a catheter into the back for postoperative pain management
Acronym
Survey of Insertion Sites for Postoperative Pain Management Catheters in the Back
Scientific Title
Investigation of Catheter Displacement and Bleeding at the Skin Insertion Site of Epidural Catheters
Scientific Title:Acronym
Survey of Epidural Catheter Insertion Sites
Region
| Japan |
Condition
Condition
Postoperative Pain That Can Be Managed with Epidural Analgesia at the Hospital Where the Researchers Are Affiliated
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Epidural catheters inserted via the back for postoperative analgesia are widely used for postoperative pain management. However, bleeding at the catheter insertion site and catheter migration may occur over time, potentially hindering the continuation of epidural analgesia.
This study aimed to assess the incidence of these complications during epidural catheterization, evaluate the impact of preventive measures, and compare the occurrence of these events before and after their implementation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The external length of the epidural catheter from the skin insertion site will be measured immediately after catheter placement, at the end of surgery, and during the morning round on postoperative day 1. In addition, the severity of insertion-site bleeding will be assessed using a five-point grading scale.
To prevent catheter migration and insertion-site bleeding, the following interventions will be implemented: (1) creation of a subcutaneous tunnel approximately 2 cm in length adjacent to the epidural catheter insertion site, and (2) application of a biocompatible tissue adhesive to the insertion site.
Patients will be allocated to one of the following four groups:
Group A: Standard epidural catheter placement alone
Group B: Application of biocompatible tissue adhesive to the insertion site following epidural catheter placement
Group C: Creation of an approximately 2-cm subcutaneous tunnel following epidural catheter placement
Group D: Creation of an approximately 2-cm subcutaneous tunnel followed by application of biocompatible tissue adhesive
The primary outcome measures will be changes in the external catheter length and the severity of insertion-site bleeding. These outcomes will be compared among the four groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Application of biocompatible tissue adhesive to the insertion site following epidural catheter placement
Interventions/Control_2
Creation of an approximately 2-cm subcutaneous tunnel following epidural catheter placement
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo surgery for which postoperative analgesia with epidural analgesia is expected to be beneficial, who are classified as American Society of Anesthesiologists (ASA) Physical Status I or II, have no abnormalities in hemostatic or coagulation function, and have provided written informed consent to participate in this study before surgery.
Key exclusion criteria
Patients meeting any of the following criteria will be excluded:
1. Patients scheduled to undergo surgery for which postoperative analgesia with epidural analgesia is not expected to be beneficial.
2. Patients classified as American Society of Anesthesiologists (ASA) Physical Status III or higher.
3. Patients undergoing emergency surgery.
4. Patients with abnormalities in hemostatic or coagulation function.
5. Patients from whom written informed consent for participation in this study could not be obtained before surgery.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Fujino |
Organization
National Hospital Organization Higashi-Ohmi General Medical Center
Division name
Department of Anesthesiology
Zip code
527-8505
Address
255, Gochi-cho, Higashioumi, Shiga, 527-8505, Japan
TEL
0748-22-3030
fujino@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Fujino |
Organization
National Hospital Organization Higashi-Ohmi General Medical Center
Division name
Department of Anesthesiology
Zip code
527-8505
Address
255, Gochi-cho, Higashioumi, Shiga, 527-8505, Japan
TEL
0748-22-3030
Homepage URL
fujino@belle.shiga-med.ac.jp
Sponsor or person
Institute
National Hospital Organization Higashi-Ohmi General Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Higashi-Ohmi General Medical Center
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
National Hospital Organization Higashi-Ohmi General Medical Center
Address
255, Gochi-cho, Higashioumi, Shiga, 527-8505, Japan
Tel
0748-22-3030
402-higashiomishomu@mail.hosp.go.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 | 27 | 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 | 05 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2028 | 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 | 26 | Day |
Last modified on
| 2026 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071015
