UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020952 |
|---|---|
| Receipt number | R000021589 |
| Scientific Title | About efficacy and effects on postoperative pain in the open heart surgery using the nerve block |
| Date of disclosure of the study information | 2016/02/10 |
| Last modified on | 2019/02/18 20:11:30 |
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Basic information
Public title
About efficacy and effects on postoperative pain in the open heart surgery using the nerve block
Acronym
About efficacy and effects on postoperative pain in the open heart surgery using the nerve block
Scientific Title
About efficacy and effects on postoperative pain in the open heart surgery using the nerve block
Scientific Title:Acronym
About efficacy and effects on postoperative pain in the open heart surgery using the nerve block
Region
| Japan |
Condition
Condition
heart surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacies of nerve block for heart surgery and its influence about postoperative pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
pain score within postoperative 3 days and 7 POD. intraoperative blood pressure and heart rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Do intercostal nerve block at parasternum to 10 Patients before operation.
0.375% Ropivacaine 40mL
Interventions/Control_2
Without intercostal nerve block at parasternum to 10 Patients.
Interventions/Control_3
Do adductor cannal block to 10 patients
0.3% Ropivacaine 6-8 mL before operation
Interventions/Control_4
Without adductor cannal block to 10 patients
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 and Female
Key inclusion criteria
Patients scheduled for open herat surgery
Key exclusion criteria
sever DM, sever liver and/or renal dysfunction, cerebral infarction, ejection fruction <40%
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikio Nonogaki |
Organization
Yokkaichi Municipal Hospital
Division name
Department of Anesthesiology
Zip code
Address
Shibata 2-2-37, Yokkaichi City, Mie, Japan
TEL
059-354-1111
minono@yokkaichihp01.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikio Nonogaki |
Organization
Yokkaichi Municipal Hospital
Division name
Department of Anesthesiology
Zip code
Address
Shibata 2-2-37, Yokkaichi City, Mie, Japan
TEL
059-354-1111
Homepage URL
minono@yokkaichihp01.jp
Sponsor or person
Institute
Department of Anesthesiology, Yokkaichi Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokkaichi Municipal Hospital
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
| 2016 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 11 | 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
| 2016 | Year | 02 | Month | 09 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021589
