UMIN-CTR Clinical Trial

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
Email	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
Email	m02a038f@yahoo.co.jp

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)

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022064