UMIN-CTR Clinical Trial

Basic information
Public title	Consideration of safety and certainty in ultrasound-guided obuturator nerve block proximal approach during transurethral resection of the bladder tumor
Acronym	Obuturator nerve block proximal approach study
Scientific Title	Consideration of safety and certainty in ultrasound-guided obuturator nerve block proximal approach during transurethral resection of the bladder tumor
Scientific Title:Acronym	Obuturator nerve block proximal approach study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the preventive effect of ultrasound-guided obuturator nerve block proximal 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 bladder tumor 1=no movement 2=slight movement,but the operation can be continued 3=sever movement,and general anesthesia is induced with rocuronium 4= perforation
Key secondary outcomes	1.The target identification time 2.Duration of puncture and block performance time 3.Obturator nerve block-related complications 4.Reaction to electrical stimulation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Before TUR-BT,ultrasound-guided obuturator nerve block proximal approach is performed
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 undergoing a TUR-BT 2.American Society of Anesthsiologists PS 1-3 3.Written informed consent is provided by a patient or proxies
Key exclusion criteria	1.Under 20 years old 2.Allergy to local anesthetics 3.Pre-existing adductor muscle dysfunction of the hip 4.Pre-existing sensory disturbance of the medial region of the knee 5.Patients who are regarded ineligible by researchers with any other reasons
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuko Shimizu
Organization	National Hospital Organization Kumamoto Medical Center
Division name	Department of Anesthesiology
Zip code
Address	1-5,Ninomaru Chuo-ku Kumamoto-city,Kumamoto,Japan
TEL	096-353-6501
Email	kazuco0613@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Naoki Miyazaki
Organization	National Hospital Organization Kumamoto Medical Center
Division name	Department of Anesthesiology
Zip code
Address	1-5,Ninomaru Chuo-ku Kumamoto-city,Kumamoto,Japan
TEL	096-353-6501
Homepage URL
Email	motomiyazaki@yahoo.co.jp

Sponsor
Institute	National Hospital Organization Kumamoto Medical Center
Institute
Department

Funding Source
Organization	No
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	2019 Year 01 Month 23 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	2019 Year 01 Month 16 Day
Date of IRB	2018 Year 12 Month 28 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 16 Day
Last modified on	2022 Year 01 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040523