UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055267 |
|---|---|
| Receipt number | R000063121 |
| Scientific Title | The Exploration of Neurological Foundations of Chronic Postoperative Pain |
| Date of disclosure of the study information | 2024/08/18 |
| Last modified on | 2024/08/15 22:10:58 |
* 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
The Exploration of Neurological Foundations of Chronic Postoperative Pain
Acronym
The Exploration of Neurological Foundations of Chronic Postoperative Pain
Scientific Title
The Exploration of Neurological Foundations of Chronic Postoperative Pain
Scientific Title:Acronym
The Exploration of Neurological Foundations of Chronic Postoperative Pain
Region
| Japan |
Condition
Condition
Chronic postoperative pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
According to overseas studies, 20-30% of patients who undergo thoracic surgery or breast surgery experience prolonged postoperative pain, and 5-10% report severe pain with a Numerical Rating Scale (NRS) score of 5 or higher. Additionally, it is known that about half of chronic postoperative pain patients experience some form of disability due to the pain. However, there are very few studies that have investigated the actual prevalence of chronic postoperative pain in Japan.
Therefore, in this study, we aim to explore the actual prevalence of chronic postoperative pain in patients undergoing elective mastectomy or thoracic surgery at Keio University Hospital.
Basic objectives2
Others
Basic objectives -Others
Recently, changes in brain function have been pointed out as factors contributing to the intractability and chronification of pain. However, research examining changes in brain function related to chronic postoperative pain is scarce, and the mechanisms by which postoperative pain becomes chronic remain unclear, leading to insufficient evaluation and treatment. In this study, we will also explore the relationship between pain intensity and brain function at 1 month after operation, as well as the neurological foundations related to chronic postoperative pain.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The average NRS at 1 month and at 3-6 months after surgery.
Key secondary outcomes
Resting NRS at 3-6 months after surgery.
Movement-evoked NRS at 3-6 months after surgery.
Resting NRS at 1 month after surgery.
Movement-evoked NRS at 1 month after surgery.
Relationship between postoperative pain intensity and brain function at 3-6 months after surgery.
Relationship between postoperative pain intensity and brain function at 1 month after surgery.
Exploration of factors leading to Chronic Post Surgical Pain based on patient background and perioperative information.
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients classified as ASA-PS Class 1 or 2 according to the American Society of Anesthesiologists' Physical Status Classification System.
Patients who provide written consent to participate in this study.
Key exclusion criteria
Patients who have any pain prior to surgery.
Patients undergoing surgery for pneumothorax or pectus excavatum in the Department of Respiratory Surgery.
Patients undergoing mastectomy with expander insertion.
Other patients who cannot undergo MRI imaging (e.g., those with claustrophobia or magnetic metallic implants in their body).
Patients currently involved in compensation claims related to pain (e.g., workers' compensation, welfare benefits) or ongoing litigation.
Patients deemed unsuitable for this study by the principal investigator or co-investigators.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Wakaizumi |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-0016
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL
03-5363-3810
kwaka@keio.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Takaoka |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-0016
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL
03-5363-3810
Homepage URL
saki.takaoka@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Kenta Wakaizumi
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 08 | Month | 18 | 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
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 08 | Month | 17 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063121
