UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059744 |
|---|---|
| Receipt number | R000063344 |
| Scientific Title | To verify the analgesic effect of intraoperative pulsed radiofrequency therapy during thoracic surgery to alleviate postoperative pain. |
| Date of disclosure of the study information | 2025/11/12 |
| Last modified on | 2025/11/12 11:08:28 |
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Basic information
Public title
To verify the analgesic effect of intraoperative pulsed radiofrequency therapy during thoracic surgery to alleviate postoperative pain.
Acronym
To verify the analgesic effect of intraoperative pulsed radiofrequency therapy during thoracic surgery to alleviate postoperative pain.
Scientific Title
To verify the analgesic effect of intraoperative pulsed radiofrequency therapy during thoracic surgery to alleviate postoperative pain.
Scientific Title:Acronym
To verify the analgesic effect of intraoperative pulsed radiofrequency therapy during thoracic surgery to alleviate postoperative pain.
Region
| Japan |
Condition
Condition
Lung cancer, Mediastinum tumor, Pneumothorax, Chest wall tumor, Valvular heart disease
Classification by specialty
| Chest surgery | Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reduce postoperative pain without adverse effects and to decrease the amount of postoperative analgesics used by performing Pulsed Radiofrequency (PRF), which has been reported to have safety and analgesic efficacy, during the perioperative period in patients undergoing respiratory and cardiovascular surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of Patients Requiring Additional Analgesics Not Included in the Clinical Pathway Due to Pain During Hospitalization
Key secondary outcomes
Frequency of Patients Experiencing NRS 4 (Poor Pain Control, Level 3) During Hospitalization
NRS at Rest and During Movement During Hospitalization (Assessed in the morning, afternoon, and evening during hospitalization)
Amount of Additional Analgesics Required During Hospitalization
NRS at Rest and During Movement During Follow-Up Visits Post-Discharge
Number of Patients Reporting Intercostal Neuralgia at Approximately 2 Weeks and 4 Weeks Postoperatively During Outpatient Visits
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Group Receiving PRF During Surgery
Interventions/Control_2
Conventional Pain Management Group
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria for the Study Group:
Individuals deemed suitable for thoracoscopic, robot-assisted thoracoscopic, or open thoracic surgery.
Age between 18 and 84 years at the time of consent.
Written informed consent has been obtained from the individual for participation in the study.
Criteria for the Control Group:
Individuals who underwent thoracoscopic, robot-assisted thoracoscopic, or open thoracic surgery at our hospital between April 2023 and March 2024.
Key exclusion criteria
Exclusion Criteria for the Study Group:
Individuals with a pacemaker that may cause electrical interference.
Women who are pregnant, breastfeeding, or have the possibility of pregnancy.
Individuals deemed inappropriate for the study by the principal investigator or co-investigators.
Exclusion Criteria for the Control Group:
Individuals who have submitted a statement of non-participation.
Target sample size
290
Research contact person
Name of lead principal investigator
| 1st name | Fumitsugu |
| Middle name | |
| Last name | Kojima |
Organization
St. Lukes International Hospital
Division name
Thoracic surgery
Zip code
1048560
Address
9-1 Akashii-cho, Chuo-ku, Tokyo, Japan
TEL
0335415151
fmkojima@luke.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kumagai |
Organization
St. Luke's International Hospital
Division name
Thoracic surgery
Zip code
1048560
Address
9-1 Akashi-machi, Chuo-ku, Tokyo, Japan
TEL
0335415151
Homepage URL
kumagai2580@gmail.com
Sponsor or person
Institute
St. Lukes International University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University
Address
9-1 Akashi-machi, Chuo-ku, Tokyo, Japan
Tel
0335415151
kumagai2580@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
24-R085
Org. issuing International ID_1
St. Luke's International Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 11 | Month | 12 | Day |
Last modified on
| 2025 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063344
