UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035566 |
|---|---|
| Receipt number | R000040523 |
| Scientific Title | Consideration of safety and certainty in ultrasound-guided obuturator nerve block proximal approach during transurethral resection of the bladder tumor |
| Date of disclosure of the study information | 2019/01/23 |
| Last modified on | 2022/01/21 11:20:32 |
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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
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
motomiyazaki@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Kumamoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040523
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
