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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027762
Receipt No. R000031815
Scientific Title A controlled study of patients undergoing transurethral bladder tumor resection to investigate the effectiveness of an ultrasound-guided inter-adductor approach for obturator nerve block
Date of disclosure of the study information 2017/06/15
Last modified on 2017/08/15

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Basic information
Public title A controlled study of patients undergoing transurethral bladder tumor resection to investigate the effectiveness of an ultrasound-guided inter-adductor approach for obturator nerve block
Acronym Controlled study using an ultrasound-guided inter-adductor approach for obturator nerve block
Scientific Title A controlled study of patients undergoing transurethral bladder tumor resection to investigate the effectiveness of an ultrasound-guided inter-adductor approach for obturator nerve block
Scientific Title:Acronym Controlled study using an ultrasound-guided inter-adductor approach for obturator nerve block
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to examine the superiority of the ultrasound-guided inter-adductor approach for an obturator nerve block.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of local anesthetic required to target the obturator nerve
Key secondary outcomes electromyogram

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 ultrasound-guided inter-adductor approach for an obturator nerve block
Interventions/Control_2 inter-adductor approach for an obturator nerve block
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)ASA-PS(American Society of Anesthesiologists-Physical Status):Classes 1 to 3
2)Patients who are scheduled to undergo transurethral bladder tumor resection
3)Obturator nerve block is required to suppress the obturator reflex during surgery
Key exclusion criteria 1)Patients with severe hepatic and renal dysfunction
2)Patients with severe thyroid disease
3)Patients having severe allergy, especially to contrast agents
4)Pregnant women, breast-feeding women, or possibly pregnant women 5)Patients with a post-operative or radiation history that may influence an obturator nerve block
6)Patients assessed by investigators as being not eligible for this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Uchino
Organization Faculty of Medicine, Oita University
Division name Departments of Anesthesiology
Zip code
Address 1-1, Idaigaoka, Hazamacho, Yufushi, Oita
TEL 097-549-4111
Email utetsuya@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Uchino
Organization Faculty of Medicine, Oita University
Division name Departments of Anesthesiology
Zip code
Address 1-1, Idaigaoka, Hazamacho, Yufushi, Oita
TEL 097-549-4111
Homepage URL
Email utetsuya@oita-u.ac.jp

Sponsor
Institute Oita University
Institute
Department

Funding Source
Organization Oita University
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
Address
Tel
Email

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 06 Month 15 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 14 Day
Last modified on
2017 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031815

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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