UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026652 |
|---|---|
| Receipt number | 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 08:33:23 |
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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
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
yuki0811izumi@yahoo.co.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030571
