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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026652
Receipt No. R000030571
Scientific Title The Efficacy of ultrasound-guided pudendal nerve block for prevention of postoperative Catheter-Related Bladder Discomfort in patients undergoing transurethral resection of bladder tumor
Date of disclosure of the study information 2017/04/01
Last modified on 2018/03/30

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Basic information
Public title The Efficacy of ultrasound-guided pudendal nerve block for prevention of postoperative Catheter-Related Bladder Discomfort in patients undergoing transurethral resection of bladder tumor
Acronym The Efficacy of ultrasound-guided pudendal nerve block for prevention of postoperative Catheter-Related Bladder Discomfort in patients undergoing transurethral resection of bladder tumor
Scientific Title The Efficacy of ultrasound-guided pudendal nerve block for prevention of postoperative Catheter-Related Bladder Discomfort in patients undergoing transurethral resection of bladder tumor
Scientific Title:Acronym The Efficacy of ultrasound-guided pudendal nerve block for prevention of postoperative Catheter-Related Bladder Discomfort in patients undergoing transurethral resection of bladder tumor
Region
Japan

Condition
Condition Transurethral resection of bladder tumor
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy of ultrasound-guided pudendal nerve block for prevention of postoperative CRBD in patients undergoing transurethral resection of bladder tumor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of CRBD at 0, 1, 2, 6 and 24h after surgery.
Key secondary outcomes The severity of CRBD at 0,1,2,6,24h after surgery
(0=no CRBD,1=mild,2=moderate,3=severe)

NRS at 0,1,2,6,24h after surgery

The severity of sciatic nerve block at 0,1,2,6,24h after surgery
(tibial nerve,peroneal nerve)
sensory(0=no block,1=analgasia,2=anesthesia)
motor(0=no block,1=paresis,2=paralysis)

Analgesic consumption at 24h after surgery


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment Maneuver
Interventions/Control_1 Pudendal nerve block is performed at the end of surgery.

In pudendal nerve block group 10ml levobupivacaine0.375% is injected in each side for total 20ml.
Interventions/Control_2 caudal anesthesia is performed at the end of surgery.

In caudal anesthsia group 20ml of levobupivacaine0.375% is injected.

Interventions/Control_3 Peripheral nerve block is not performed in the control group.
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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male
Key inclusion criteria ASA physical status1-3
Patients scheduled for elective transurethral resection of bladder tumor
Key exclusion criteria bladder outflow obstruction,overactive bladder(which is defined as urinary frequency more than three times in the night or more than eight times in 24 h),end-stage renal disease(serum creatinine>1.6mg/dl),neurogenic bladder,morbid obesity,use of chronic analgesic medication,use of muscarinic receptor antagonists,psychiatirc disease,allergy of local anesthetics,peripheral neuropathy
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Izumi
Organization Asahikawa Medical University
Division name Department of Anesthesiology&Critical care
Zip code
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
TEL 0166682583
Email yuki0811izumi@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Izumi
Organization Asahikawa Medical University
Division name Department of Anesthesiology&Critical care
Zip code
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
TEL 0166682583
Homepage URL
Email yuki0811izumi@yahoo.co.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 04 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 Terminated
Date of protocol fixation
2017 Year 02 Month 01 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 03 Month 22 Day
Last modified on
2018 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030571

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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