UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060756 |
|---|---|
| Receipt number | R000069522 |
| Scientific Title | Investigation of risk factors associated with chronic postoperative pain in patients undergoing respiratory surgery. |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/26 15:41:36 |
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Basic information
Public title
Investigation of risk factors associated with chronic postoperative pain in patients undergoing respiratory surgery.
Acronym
Investigation of risk factors associated with chronic postoperative pain in patients undergoing respiratory surgery.
Scientific Title
Investigation of risk factors associated with chronic postoperative pain in patients undergoing respiratory surgery.
Scientific Title:Acronym
Investigation of risk factors associated with chronic postoperative pain in patients undergoing respiratory surgery.
Region
| Japan |
Condition
Condition
Post-thoracotomy pain syndrome
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to prospectively investigate risk factors leading to PTPS in patients undergoing respiratory surgery, with particular focus on clarifying the impact of patient frailty on the development of PTPS. Through this, we seek to establish a scientific basis for risk stratification and preventive interventions for PTPS, thereby contributing to improved pain management and maintenance of functional status in elderly patients.
Basic objectives2
Others
Basic objectives -Others
Examination of risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of PTPS at 3 months after surgery
Key secondary outcomes
1. Pain score (VAS, NRS, McGill Pain Questionnaire, PCS, EQ-5D, PDAS)
2. Analgesic consumption
3. Frailty (Barthel index, short physical performance, J-CHS, J-CFS)
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
Male and Female
Key inclusion criteria
Patients scheduled to undergo respiratory surgery who are 18 years of age or older at the time of informed consent and who provide consent to participate in the study.
Key exclusion criteria
Patients whose surgical procedure was changed (e.g., conversion to thoracotomy), patients for whom follow-up is difficult, and patients with deformities of the lower extremities or measurement sites or a history of surgery at those sites that would preclude accurate gait testing or muscle thickness measurement.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Tsujikawa |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
l-5-7, Asahimachi, Abenoku, Osaka, 545-8586, Japan
TEL
06-6645-2186
shogo.tsujikawa@omu.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Tsujikawa |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
l-5-7, Asahimachi, Abenoku, Osaka, 545-8586, Japan
TEL
06-6645-2186
Homepage URL
shogo.tsujikawa@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
none
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
Department of Anesthesiology, Osaka Metropolitan University Graduate School of Medicine
Address
l-5-7, Asahimachi, Abenoku, Osaka, 545-8586, Japan
Tel
06-6645-2186
shogo.tsujikawa@omu.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 | 03 | Month | 01 | 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 | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients will visit the anesthesia outpatient clinic at 1 and 3 months after surgery to assess the presence or absence of pain.
Management information
Registered date
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069522
