UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	About efficacy and effects on postoperative pain in the open heart surgery using the nerve block
Title of the study (Brief title)	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	Mikio Nonogaki
Organization	Yokkaichi Municipal Hospital
Division name	Department of Anesthesiology
Address	Shibata 2-2-37, Yokkaichi City, Mie, Japan
TEL	059-354-1111
Email	minono@yokkaichihp01.jp

Public contact
Name of contact person	Mikio Nonogaki
Organization	Yokkaichi Municipal Hospital
Division name	Department of Anesthesiology
Address	Shibata 2-2-37, Yokkaichi City, Mie, Japan
TEL	059-354-1111
Homepage URL
Email	minono@yokkaichihp01.jp

Sponsor
Institute	Department of Anesthesiology, Yokkaichi Municipal Hospital
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021589