UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016077 |
|---|---|
| Receipt number | 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 18:44:54 |
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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
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
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Biomedical Regulation, Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018681
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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