UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060382 |
|---|---|
| Receipt number | R000069075 |
| Scientific Title | Exploratory Study of Parent-Child Biomarkers for Improvement of Postoperative Pain Management in Pediatric Musculoskeletal Surgery: A Prospective Cohort Study |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/16 17:22:16 |
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Basic information
Public title
Exploratory Study of Parent-Child Biomarkers for Improvement of Postoperative Pain Management in Pediatric Musculoskeletal Surgery: A Prospective Cohort Study
Acronym
Exploratory Study of Parent-Child Biomarkers for Improvement of Postoperative Pain Management in Pediatric Musculoskeletal Surgery: A Prospective Cohort Study
Scientific Title
Exploratory Study of Parent-Child Biomarkers for Improvement of Postoperative Pain Management in Pediatric Musculoskeletal Surgery: A Prospective Cohort Study
Scientific Title:Acronym
Exploratory Study of Parent-Child Biomarkers for Improvement of Postoperative Pain Management in Pediatric Musculoskeletal Surgery: A Prospective Cohort Study
Region
| Japan |
Condition
Condition
Postoperative pain in pediatric musculoskeletal surgery
Classification by specialty
| Orthopedics | Anesthesiology | Plastic surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Postoperative pain is substantial after pediatric musculoskeletal surgery. This study aims to explore biomarkers associated with the intensity of acute postoperative pain and the developmental factor(s) of chronic postsurgical pain (pain persisting for at least 3 months after surgery) by collecting varied parent-child information.
Basic objectives2
Others
Basic objectives -Others
To explore parent-child biomarkers associated with postoperative pain.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chronic postsurgical pain at 3 months
Key secondary outcomes
1) Acute postoperative pain intensity assessed using NRS or the Face Rating Scale
2) Perioperative opioid consumption
3) Anxiety and psychological assessments
4) Biomarkers
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or younger undergoing musculoskeletal surgery and their parent
Key exclusion criteria
1) Parents who are unable to complete the Japanese-language questionnaires.
2) Patient-parent pairs deemed inappropriate for participation by the investigators.
3) Failure to obtain informed consent.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Saya |
| Middle name | |
| Last name | Nagata |
Organization
The University of Tokyo Hospital
Division name
Palliative Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo, Tokyo
TEL
+81-3-3815-5411
nagatas-ane@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Saya |
| Middle name | |
| Last name | Nagata |
Organization
The University of Tokyo Hospital
Division name
Palliative Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo, Tokyo
TEL
+81-3-3815-5411
Homepage URL
nagatas-ane@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Saya Nagata
Funding Source
Organization
The University of Tokyo Hospital, Department of Palliative Medicine
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
The University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo, Tokyo
Tel
+81-3-3815-5411
nagatas-ane@h.u-tokyo.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 | 01 | Month | 20 | 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
| 2025 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center prospective observational study.
Management information
Registered date
| 2026 | Year | 01 | Month | 16 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069075
