UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049105 |
|---|---|
| Receipt number | R000055941 |
| Scientific Title | Effect of portable ultrasound-guided trigger point block with levobupivacaine on myofascial pain syndrome in patients with advanced cancer |
| Date of disclosure of the study information | 2022/10/05 |
| Last modified on | 2024/01/22 20:45:40 |
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Basic information
Public title
Effect of portable ultrasound-guided trigger point block with levobupivacaine on myofascial pain syndrome in patients with advanced cancer
Acronym
Effect of portable ultrasound-guided trigger point block in patients with advanced cancer
Scientific Title
Effect of portable ultrasound-guided trigger point block with levobupivacaine on myofascial pain syndrome in patients with advanced cancer
Scientific Title:Acronym
Effect of portable ultrasound-guided trigger point block on myofascial pain syndrome in patients with advanced cancer
Region
| Japan |
Condition
Condition
myofascial pain syndrome
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A portable ultrasound-guided trigger point block is performed for myofascial pain syndrome in patients with advanced cancer, its efficacy and safety are confirmed, and the possibility of application to home medical care including palliative care is examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the difference in pain (NRS) on day 8 compared to pre-block
Key secondary outcomes
(1) Difference in pain (NRS) after block on day 1 compared to pain before block on day 1
(2) Difference in pain (NRS) before block on day 4 compared to pain before block on day 1
(3) Difference in pain (NRS) after block on day 4 compared to pain before block on day 1
(4) Difference in opioid dose (oral morphine equivalent) before block on day 1 and on day 8
(5) Frequency of adverse events
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Inpatients aged 20 to 85 who have been diagnosed with advanced cancer
(2) Subjects whose palliative care team is intervening
(3) Subjects taking opioids
(4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 2-4
(5) Subjects diagnosed with myofascial pain syndrome that meets River's diagnostic criteria
(6) Subjects who have the pain of 4/10 or higher on the Numerical Rating Scale (NRS) in the affected area of myofascial pain syndrome
(7) Subjects whose cause of myofascial pain syndrome is determined to be bed rest for 1 week or longer
(8) Subjects who can visualize the muscle layer of the painful area of myofascial pain syndrome using a portable ultrasound device
(9) Individuals who are clear-minded and have the ability to make decisions
(10) Subjects were judged to be able to keep quiet during the procedure
Key exclusion criteria
(1) Subjects taking anticoagulants or antiplatelet drugs
(2) Subjects who are suggested to be prone to bleeding
(3) Subjects with severe cytopenia
(4) Those who are suggested to be susceptible to infection
(5) Subjects with skin abnormalities such as redness, swelling, and edema at painful areas suspected of MPS
(6) Subjects with chronic heart failure
(7) Subjects with serious renal impairment
(8) Subjects with severe liver disorder
(9) Subjects who are allergic to local anesthetics
(10) Subjects whose cause of the pain may be other than MPS due to bed rest
(11) Body Mass Index (BMI) of 35 or more, or those who have difficulty in visualizing the muscle layer of the MPS pain site with a portable ultrasound device
(12) Subjects who cannot keep quiet during the procedure
(13) A person judged to have no decision-making capacity
(14) Others who are judged to be inappropriate as subjects by the principal investigator
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yamamoto |
Organization
Shinshu University Hospital
Division name
Palliative care center
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
TEL
0263-35-4600
cab55640@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Yamamoto |
Organization
Shinshu University Hospital
Division name
Palliative care center
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
TEL
0263-35-4600
Homepage URL
cab55640@yahoo.co.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Shinshu University Hospital, Palliative care center
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
Tel
0263-35-4600
cab55640@yahoo.co.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
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is the prospective observational and pre-post study of the trigger point block for inpatients with advanced cancer in our hospital.
Portable ultrasound-guided trigger point blocks using 0.25% levobupivacaine are enforced on day 1 and day 4. 0.5 to 3 ml of local anesthetic is delivered at a trigger point. The total amount of the local anesthetic is less than 10 ml a day.
Management information
Registered date
| 2022 | Year | 10 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055941
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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