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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029286
Receipt No. R000033474
Scientific Title Preventive effects of ultrasound-guided obturator nerve block distal approach on adductor muscle contraction during transurethral resection of the bladder tumor: a prospective, observational study
Date of disclosure of the study information 2017/10/01
Last modified on 2019/05/05

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Basic information
Public title Preventive effects of ultrasound-guided obturator nerve block distal approach on adductor muscle contraction during transurethral resection of the bladder tumor: a prospective, observational study
Acronym Preventive effects of ultrasound-guided obturator nerve block distal approach on adductor muscle contraction during transurethral resection of the bladder tumor: a prospective, observational study
Scientific Title Preventive effects of ultrasound-guided obturator nerve block distal approach on adductor muscle contraction during transurethral resection of the bladder tumor: a prospective, observational study
Scientific Title:Acronym Preventive effects of ultrasound-guided obturator nerve block distal approach on adductor muscle contraction during transurethral resection of the bladder tumor: a prospective, observational study
Region
Japan

Condition
Condition Bladder tumor
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To observe the preventive effect of ultrasound-guided obturator nerve block distal approach on adductor muscle contraction during transurethral resection of the bladder tumor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Degree of lower limb movement during transurethral resection of the bladder tumor using socore; 1=no movement, 2=slight movement, 3=moderate movement, 4=severe movement, 5=perforation
Key secondary outcomes

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 1)Patients who are schedulled for transurethral bladder tumor resection under spinal anesthesia.
2)Patients who need obturator nerve block for transurethral bladder tumor resection.
3)American Society of Anesthesiologists physical status 1~3
Key exclusion criteria 1)Peripheral neuropathy on lower limb
2)Allergy to local anesthetic used
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Sakura
Organization Shimane University Hospital
Division name Operation department
Zip code 693-8501
Address 89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL +81853202295
Email ssakura@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Sakura
Organization Shimane University Hospital
Division name Operation department
Zip code 693-8501
Address 89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL 0853-20-2295
Homepage URL
Email ssakura@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization none
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 Shimane University Hospital, Clinical Trial Review Board
Address 89-1 Enya-cho, Izumo-shi, Shimane, Japan
Tel +81-853-20-2515
Email kenkyu@med.shimane-u.ac.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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 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
2017 Year 09 Month 25 Day
Date of IRB
2017 Year 09 Month 25 Day
Anticipated trial start date
2017 Year 09 Month 30 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We are going to observe preventive effects of ultrasound-guided obturator nerve block distal approach on adductor muscle contraction during transurethral resection of the bladder tumor. Urologist will evaluate the adductor muscle contraction during surgery.

Management information
Registered date
2017 Year 09 Month 25 Day
Last modified on
2019 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033474

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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