UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of the ultrasound-guided thoracic wall nerve blocks to the breast surgery.
Title of the study (Brief title)	The effectiveness of the ultrasound-guided thoracic wall nerve blocks to the breast surgery.
Region	Japan

Condition
Condition	Elective mastectomy for breast cancer
Classification by specialty	Breast surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this study I consider the effectiveness of acute pain and chronic pain of breast cancer after surgery due to Thoracic wall nerve block (PECS2 block and serratus plane block).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Chronic pain after 6 months (use NRS;Numeric Rating Scale)
Key secondary outcomes	Chronic pain after 2 months (use NRS;Numeric Rating Scale) Acute pain after 24 hours (use VAS;Visual Analog Scale) Dose of postoperative morphine Health Related Quality of Life after 2 months and 6 months (use EuroQol-5D)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	PECS2 block
Interventions/Control_2	Serratus plane block
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	Female
Key inclusion criteria	Elective mastectomy for breast cancer American Society of Anesthesiologists Physical Status Classification 1-2 Preoperative ADL is independence Written informed consent is provided
Key exclusion criteria	Consciousness disabilities Enough judgment ability nothing Male Emergency ASA-PS over 3 History of hypersensitivity to ropivacaine or amide type local anesthetic Hemodialysis Renal dysfunction (less than eGFR30) Liver dysfunction (Child-Pugh classification more B) Blood clotting disorder (less than 100,000 platelets/mcl, PT-INR 1.5 or more, less than APTT% 70%)
Target sample size	80

Research contact person
Name of lead principal investigator	Kimitoshi Nishiwaki
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Anesthesiology
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	Tasuku Fujii
Organization	Nagoya University Hospital
Division name	Department of Anesthesiology
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)

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 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 01 Day
Last modified on	2018 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019349