UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059742 |
|---|---|
| Receipt number | R000062954 |
| Scientific Title | Evaluation of the analgesic effect of adding intraoperative pulsed radiofrequency therapy to conventional perioperative pain management. |
| Date of disclosure of the study information | 2025/11/12 |
| Last modified on | 2025/11/12 10:34:05 |
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Basic information
Public title
Evaluation of the analgesic effect of adding intraoperative pulsed radiofrequency therapy to conventional perioperative pain management.
Acronym
Evaluation of the analgesic effect of adding intraoperative pulsed radiofrequency therapy to conventional perioperative pain management.
Scientific Title
Evaluation of the analgesic effect of adding intraoperative pulsed radiofrequency therapy to conventional perioperative pain management.
Scientific Title:Acronym
Evaluation of the analgesic effect of adding intraoperative pulsed radiofrequency therapy to conventional perioperative pain management.
Region
| Japan |
Condition
Condition
post-thoracotomy pain
Classification by specialty
| Surgery in general | Vascular surgery | Chest surgery |
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intraoperative PRF, which has been reported to be safe and analgesic in addition to conventional analgesic methods in the perioperative period of respiratory surgery, is intended to reduce postoperative pain without side effects and to reduce the use of analgesics in the postoperative period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of patients requiring additional analgesics not on the clinical pathway due to pain during hospitalization
Key secondary outcomes
Frequency of patients experiencing NRS4 (poor pain control3)) during hospitalization
NRS at rest and during physical activity during hospitalization (extubation was defined as 0 hours after surgery, 1.6.12.24.48 hours after surgery, and during hospitalization
(Listening in the morning, noon, and evening)
Amount of additional analgesia required during hospitalization
NRS at rest and during physical activity in the outpatient setting after discharge
Number of patients who perceived intercostal neuralgia in the outpatient setting at 2 and 4 weeks postoperatively, respectively
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 |
Interventions/Control_1
Groups that add intraoperative PRF to conventional pain management
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
The intervention group will include those who meet all of the following criteria
1) Patients deemed appropriate to undergo thoracoscopic or robotic-assisted thoracoscopic surgery.
2) Have a resectable pulmonary lesion.
3) Are between the ages of 18 and 85 years at the time consent is obtained.
4) Have obtained written consent from the individual to participate in this study.
Key exclusion criteria
The intervention group will not include in the study any of the following
1) Patients who take analgesics as their regular medication.
2) Patients who undergo resection other than lung lesions at the same time
3) Patients with renal dysfunction (eGFR 50)
4) Patients who cannot take NSAIDs due to allergy, etc.
5) Patients with implanted pacemakers that may cause electrical interference
6) Patients who require open chest surgery due to bleeding or severe adhesions
7) Women who are lactating, pregnant, or may become pregnant
8) Other subjects deemed inappropriate by the principal investigator (co-investigator).
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Fumitsugu |
| Middle name | |
| Last name | Kojima |
Organization
St. Luke's 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. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
St. Luke's International University
Organization
Division
Category of Funding Organization
Profit organization
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
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
| 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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
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=R000062954
