UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of anterior thoracic wall blocks in patients undergoing breast surgery: comparison of postoperative pain between patients with or without the block
Title of the study (Brief title)	Thoracic wall blocks
Region	Japan

Condition
Condition	Breast cancer that requires surgery on the chest wall
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To see the effects of ultrasound-guided thoracic wall blocks including pectoral nerves blocks) on pain during and after breast surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative VAS scores
Key secondary outcomes	Postoperative opioid consumption Intraoperative opioid consumption

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Ultrasound-guided thoracic wall blocks and general anesthesia
Interventions/Control_2	General anesthesia alone
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	Patients undergoing breast surgery for breast cancer
Key exclusion criteria	Patients with a history of diabetes mellitus and neurologic diseases, and infection at the site of injection
Target sample size	60

Research contact person
Name of lead principal investigator	Shinichi Sakura
Organization	Shimane University, Faculty of Medicine, University Hospital
Division name	Surgical Center
Address	89-1, Enya-cho, Izumo City, Shimane
TEL	0853-20-2295
Email	ssakura@med.shimane-u.ac.jp

Public contact
Name of contact person	Shinichi Sakura
Organization	Shimane University, Faculty of Medicine, University Hospital
Division name	Surgical Center
Address	89-1, Enya-cho, Izumo City, Shimane
TEL	0853-20-2295
Homepage URL
Email	ssakura@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University, Faculty of Medicine, University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Shimane University, Faculty of Medicine, University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Hospital Organization, Hamada Medical Center
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	島根大学医学部附属病院（島根県）、浜田医療センター（島根県）

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 01 Day
Anticipated trial start date	2014 Year 11 Month 11 Day
Last follow-up date	2016 Year 11 Month 10 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

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

Management information
Registered date	2013 Year 11 Month 11 Day
Last modified on	2016 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014202