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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032838
Receipt No. R000037449
Official scientific title of the study Usefullness of Rectus Sheath Block and Transversus Abdominis Plane Block for continuous ambulatory peritoneal dialysis catheter surgery in patient with chronic renal failure; case series
Date of disclosure of the study information 2018/06/04
Last modified on 2018/11/30

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Basic information
Official scientific title of the study Usefullness of Rectus Sheath Block and Transversus Abdominis Plane Block for continuous ambulatory peritoneal dialysis catheter surgery in patient with chronic renal failure; case series
Title of the study (Brief title) Usefullness of RSB/TAPB for CAPD catheter surgery in patient with chronic renal failure; 5 case report series
Region
Japan

Condition
Condition Chronic Renal Failure
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety and Efficacy of Rectus Sheath Block and Transversus Abdominis Plane Block for major anesthetic management for continuous ambulatory peritoneal dialysis catheter surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of anesthetic management without conversion to other anesthetic management
Key secondary outcomes 1. Dose of local anesthetics
2. Dose of fentanyl
3. Dose of dexmedetomidine
4. Surgeon satisfaction

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients performing peritoneal dialysis catheterization with chronic renal failure
Key exclusion criteria 1. Difficult case to keep quiet because of dementia or parkinsonism
2. Difficult case of nerve block
3. Local anesthetics allergy
Target sample size 5

Research contact person
Name of lead principal investigator Seishi Sakamoto
Organization International University of Healthcare and Welfare Hospital
Division name Department of Anesthesiology
Address 537-3, Iguchi, Nasushiobara city, Tochigi Prefecture
TEL 0287-37-2221
Email ssakamoto@iuhw.ac.jp

Public contact
Name of contact person Seishi Sakamoto
Organization International University of Healthcare and Welfare Hospital
Division name Department of Anesthesiology
Address 537-3, Iguchi, Nasushiobara city, Tochigi Prefecture
TEL 0287-37-2221
Homepage URL
Email ssakamoto@iuhw.ac.jp

Sponsor
Institute International University of Healthcare and Welfare
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 06 Month 04 Day

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 06 Month 04 Day
Anticipated trial start date
2018 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information observeation study
Sedation with intravenous anesthetics may be used in combination

Management information
Registered date
2018 Year 06 Month 01 Day
Last modified on
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037449

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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