UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the novel ultrasound-guided obturator nerve block technique
Title of the study (Brief title)	Novel ultrasound-guided obturator nerve block technique
Region	Japan

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

Objectives
Narrative objectives1	To examine success rates of the novel ultrasound-guided obturator nerve block
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success rates of an obturator nerve block, which is determined by reduction of the hip adduction strength
Key secondary outcomes	The time required to perform an obturator nerve block Incidence of accidental leg movement during surgery Sensory block of the medial region of the knee

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 undergoing a TUR-Bt 2. American Society of Anesthesiologists PS 1-3 3. Written informed consent is provided
Key exclusion criteria	1. Inability to communicate lucidly 2. Under 20 years old 3. Allergy to local anesthetics 4. Pre-existing adductor muscle dysfunction of the hip 5. Pre-existing sensory disturbance of the medial region of the knee 6. Patients who are regarded ineligible by researchers with any other reasons
Target sample size	60

Research contact person
Name of lead principal investigator	Kenta Furutani
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Anesthesiology
Address	1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL	025-227-2328
Email	kenta-f@med.niigata-u.ac.jp

Public contact
Name of contact person	Takayuki Yoshida
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Anesthesiology
Address	1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL	025-227-2328
Homepage URL
Email	ytaka@mac.com

Sponsor
Institute	Niigata University Medical and Dental Hospital
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)

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	新潟大学医歯学総合病院（新潟県）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 02 Day
Last follow-up date	2015 Year 06 Month 18 Day
Date of closure to data entry	2015 Year 06 Month 20 Day
Date trial data considered complete	2015 Year 06 Month 20 Day
Date analysis concluded	2015 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	To evaluate both success rates, which is determined by reduction of the hip adduction strength, and performance time of the novel ultrasound-guided obturator nerve block

Management information
Registered date	2014 Year 12 Month 01 Day
Last modified on	2018 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018392