UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017986 |
|---|---|
| Receipt number | R000020842 |
| Scientific Title | The analgesic effect of terminal nerve block on leg ischemic pain |
| Date of disclosure of the study information | 2015/06/19 |
| Last modified on | 2020/01/08 10:38:25 |
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Basic information
Public title
The analgesic effect of terminal nerve block on leg ischemic pain
Acronym
The terminal nerve block for leg ischemic pain
Scientific Title
The analgesic effect of terminal nerve block on leg ischemic pain
Scientific Title:Acronym
The terminal nerve block for leg ischemic pain
Region
| Japan |
Condition
Condition
leg ischemic pain
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Vascular surgery |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To axamine the effect of the terminal nerve block on leg ischemic pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
numerical rating scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Medicine |
Interventions/Control_1
lidocaine
Interventions/Control_2
saline
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 20 years or older
2. More than 3 months of pain duration
3. More than 4 of Numerical Rating Scale
Key exclusion criteria
1. infection
2. severe psychiatric disorders
3. serious chronic diseases; cardiac failure, pulmonary emphysema, and interstitial hepatitis
4. lidocaine allergy
5. lidocaine treatment within a week
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Akifumi |
| Middle name | |
| Last name | Kanai |
Organization
Kitasato University School of Medicine
Division name
Research and Development Center for New Medical Frontiers
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
TEL
042-778-8111
kanaiakifumi@aol.com
Public contact
Name of contact person
| 1st name | Akifumi |
| Middle name | |
| Last name | Kanai |
Organization
Kitasato University School of Medicine
Division name
Research and Development Center for New Medical Frontiers
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
TEL
042-778-8111
Homepage URL
kanaiakifumi@aol.com
Sponsor or person
Institute
Department of Anesthesiology, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Hospital
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
Kitasato University Hospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
Tel
+81-42-778-8111
kanaiakifumi@aol.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
| 2015 | Year | 06 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2015 | Year | 06 | Month | 19 | Day |
Last modified on
| 2020 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020842
