UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Title of the study (Brief title)	The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Region	Japan

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

Objectives
Narrative objectives1	Analgesic effect in perioperative period
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analgesic scores after surgery
Key secondary outcomes	Analgesic doses complidations(nausea,vomitting)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are 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	only PECS block
Interventions/Control_2	combination Pectoral Nerve Block and Transversus Thoracic Muscle 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	initial breast surgery
Key exclusion criteria	poor communication patient
Target sample size	70

Research contact person
Name of lead principal investigator	Hironobu UESHIMA
Organization	Showa University Hospital
Division name	Anesthesiology
Address	142-8666 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8875
Email	ueshim@yahoo.co.jp

Public contact
Name of contact person	Hironobu UESHIMA
Organization	Showa Universtiry Hospital
Division name	Anesthesiology
Address	142-8666 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8875
Homepage URL
Email	ueshimhi@yahoo.co.jp

Sponsor
Institute	Department of Anesthesiology, Showa University Hospital
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Showa University 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	2015 Year 07 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 16 Day
Anticipated trial start date	2015 Year 07 Month 16 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 14 Day
Last modified on	2016 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021180