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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016077
Receipt No. R000018681
Scientific Title The effectiveness of the parasternal intercostal nerve block for median sternotomy in cardiac surgery
Date of disclosure of the study information 2015/02/01
Last modified on 2016/02/08

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Basic information
Public title The effectiveness of the parasternal intercostal nerve block for median sternotomy in cardiac surgery
Acronym The effectiveness of the intercostal nerve anterior cutaneous branch block
Scientific Title The effectiveness of the parasternal intercostal nerve block for median sternotomy in cardiac surgery
Scientific Title:Acronym The effectiveness of the intercostal nerve anterior cutaneous branch block
Region
Japan

Condition
Condition median sternotomy in cardiac surgery
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In cardiac surgery with median sternotomy, parasternal intercostal nerve block is considered an effective methods to intraoperative management and early recovery(fast track). This study, to examine the effectiveness of the parasternal intercostal nerve block(intercostal anterior cutaneous branch block) in median sternotomy approach of cardiac surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Perioperative hemodynamics
Key secondary outcomes Dose of opioids
Time to extubation
Length of intensive care unit
Postoperative complications(Renal failure,P/F ratio,Pneumonia,Stroke,major bleeding,myocardial infraction)
Postoperative 30days mortality
Degree of postoperative pain(VAS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 parasternal intercostal nerve block with ropivacine 60ml(3mg/kg)(each10ml)
[6 point of parasternal]
Interventions/Control_2 parasternal intercostal nerve block with normal saline 60ml(each10ml)
[6 point of parasternal]
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients scheduled valvular heart disease surgery
Patients preoperative ADL is independent
That obtained the written consent from the patient
Key exclusion criteria Coronary artery bypass grafting
Valvular disease surgery with coronary artery bypass grafting
Not have the enough judgment ability
Emergency surgery
Hypersensitivity to ropivacaine or amide type local anesthetia
Hemodialysis
Renal dysfunction (less than eGFR30)
Liver dysfunction patients (Child-Pugh classification more B)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimitoshi Nishiwaki
Organization Nagoya University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL 052-744-2340
Email nishi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tasuku Fujii
Organization Nagoya University Hospital
Division name Department of Anesthesiology
Zip code
Address 65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL 052-744-2340
Homepage URL
Email plus9@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Biomedical Regulation, Department of Anesthesiology
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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 名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 02 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 Enrolling by invitation
Date of protocol fixation
2014 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 12 Month 29 Day
Last modified on
2016 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018681

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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