UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061906 |
|---|---|
| Receipt number | R000070838 |
| Scientific Title | Cost-utility analysis of transversus abdominis plane block versus caudal block for pediatric lower abdominal surgery under the current Japanese reimbursement system: a simulation study |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/15 01:34:32 |
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Basic information
Public title
A simulation study comparing cost-effectiveness of transversus abdominis plane block and caudal block in children undergoing lower abdominal surgery
Acronym
Cost-effectiveness analysis of regional anesthesia adjunctive to general anesthesia for pediatric lower abdominal surgery
Scientific Title
Cost-utility analysis of transversus abdominis plane block versus caudal block for pediatric lower abdominal surgery under the current Japanese reimbursement system: a simulation study
Scientific Title:Acronym
CEA of PRB in Japan
Region
| Japan |
Condition
Condition
Postoperative pain management in children undergoing lower abdominal surgery
Classification by specialty
| Pediatrics | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare general anesthesia plus transversus abdominis plane block with general anesthesia plus caudal block for pediatric lower abdominal surgery and to conduct a cost-utility analysis from the public healthcare payer perspective in Japan. In addition, the study will assess how changes in reimbursement points for nerve block add-on fees affect cost-utility.
Basic objectives2
Others
Basic objectives -Others
Economic evaluation and cost-utility assessment
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incremental cost-utility ratio based on post-operative quality-adjusted life years
Key secondary outcomes
Avoidance of rescue analgesia within 24 hours, expected cost, expected quality-adjusted life years, net monetary benefit, cost-effectiveness acceptability, and threshold reimbursement points for nerve block add-on fees
Base
Study type
Others,meta-analysis etc
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
| 1 | days-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A model-based target population of children younger than 18 years undergoing lower abdominal or infraumbilical surgery under general anesthesia with either transversus abdominis plane block or caudal block for postoperative analgesia. Clinical effectiveness parameters will be derived from randomized controlled trials and a systematic review and meta-analysis comparing the two techniques.
Key exclusion criteria
Studies involving adults, studies of procedures substantially different from the intended indication such as thoracic surgery or extensive upper abdominal surgery, studies without a valid comparison between the two techniques, and studies in which key model parameters cannot be extracted.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Soichiro |
| Middle name | |
| Last name | Obara |
Organization
Teikyo University
Division name
Graduate School of Public Health
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, JAPAN
TEL
03-3964-1211
soichoba1975@gmail.com
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Obara |
Organization
Teikyo University
Division name
Graduate School of Public Health
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, JAPAN
TEL
03-3964-1211
Homepage URL
soichoba1975@gmail.com
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Soichiro Obara
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University
Address
2-11-1 Kaga, Itabashi, Tokyo
Tel
03-3964-1211
soichoba1975@gmail.com
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
帝京大学 大学院 公衆衛生学研究科
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2027 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 09 | Month | 30 | Day |
Other
Other related information
This study is a model-based simulation using only secondary data from published literature, publicly available reimbursement schedules, and official drug price lists. No new participant enrollment, intervention, or collection of personal information will be conducted. The primary analysis is a cost-utility analysis from the public healthcare payer perspective, and the primary outcome is the incremental cost-utility ratio based on post-operative quality-adjusted life years. Clinical effectiveness parameters will be derived from a systematic review and meta-analysis comparing transversus abdominis plane block and caudal block for pediatric lower abdominal surgery. Pain-related utility decrement will be approximated from published data on postoperative health-related quality of life in children.
Management information
Registered date
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070838
