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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017986
Receipt No. 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

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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
Email 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
Email kanaiakifumi@aol.com

Sponsor
Institute Department of Anesthesiology, Kitasato University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020842

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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