UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019083 |
|---|---|
| Receipt number | R000022064 |
| Scientific Title | Efficacy of local anesthetic injection in urethra for catheter-related bladder discomfort in patients after endovascular repair of abdominal aortic aneurysms: a randomized, placebo-controlled, double-blind study |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2021/01/06 23:46:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of local anesthetic injection in urethra for catheter-related bladder discomfort in patients after endovascular repair of abdominal aortic aneurysms: a randomized, placebo-controlled, double-blind study
Acronym
Efficacy of local anesthetic injection in urethra after endovascular repair of abdominal aortic aneurysms
Scientific Title
Efficacy of local anesthetic injection in urethra for catheter-related bladder discomfort in patients after endovascular repair of abdominal aortic aneurysms: a randomized, placebo-controlled, double-blind study
Scientific Title:Acronym
Efficacy of local anesthetic injection in urethra after endovascular repair of abdominal aortic aneurysms
Region
| Japan |
Condition
Condition
Adult male patients undergoing elective endovascular repair of abdominal aortic aneurysms
Classification by specialty
| Vascular surgery | Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the hypothesis that local anesthetic injection in urethra with NMOC-3Way catheter reduce catheter-related bladder discomfort
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of catheter-related bladder discomfort at postoperative 0h.
Catheter-related bladder discomfort is defined as follows:
1. No discomfort, 2. Mild: revealed on questioning only, 3. Moderate: stated by the patient without being questioned, 4. Severe: urinary urgency demonstrated by behavioral responses such as attempts to remove the urinary catheter, restless extremity movements, verbal responses.
Key secondary outcomes
1. Severity of catheter-related bladder discomfort at postoperative 0h
2. Need of local anesthetic injection in urethra at postoperative 0, 1, 2, 4, 6h
3. Local anesthetic toxicity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
10ml of 2% lidocaine injection in urethra through injection port after surgery
Interventions/Control_2
10ml of normal saline injection in urethra through injection port after surgery
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
Key inclusion criteria
Adult male patients undergoing elective endovascular repair of abdominal aortic aneurysms
Patients who provide written informed consent
Key exclusion criteria
Patients
- with history of allergy for local anesthetic
- with American Society of Anesthesiologists Physical States (ASA-PS) over IV
- with history of bladder outflow obstruction
- with history of overactive bladder (frequency >3 times in the night or >8 times in 24 h)
- with history of neurogenic bladder
- with end-stage renal disease (urine output <500 ml per 24 h)
- with morbid obesity
- with disturbances of the central nervous system
- with chronic analgesic abuse
- with psychiatric disease
- with severe hepatic disease
- who is judged inappropriate for this study by investigator
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Imai |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anesthesiology
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL
025-227-2328
hdkzimi@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Seino |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anesthesiology
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL
025-227-2328
Homepage URL
m02a038f@yahoo.co.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
the institutional ethics committee of Niigata University Medical and Dental Hospital
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata
Tel
025-227-2625
ethics@adm.niigata-u.ac.jp
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
| 2015 | Year | 10 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 20 | Day |
Last modified on
| 2021 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022064
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
