UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Brachial plexus block compared with periarticular injection for pain control following arthroscopic rotator cuff repair: a randomized controlled trial
Title of the study (Brief title)	Brachial plexus block compared with periarticular injection for pain control following arthroscopic rotator cuff repair: a randomized controlled trial
Region	Japan

Condition
Condition	Rotator cuff tear
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effectiveness of brachial plexus block and periarticular injection for arthroscopic rotator cuff repair
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain score (Numeric Rating Scale)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	Brachial plexus block
Interventions/Control_2	Periarticular injection
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients scheduled for arthroscopic rotator cuff repair.
Key exclusion criteria	Patients with ASA status III-V, renal insufficiency, hepatic insufficiency, blood coagulation abnormality, prolonged QT interval on electrocardiograms, respiratory complication, poor controlled DM, and allergy or intolerance to one of the study drugs.
Target sample size	34

Research contact person
Name of lead principal investigator	Masayoshi Saito, Atsushi Tasaki, Sachiyuki Tsukada
Organization	St. Luke's international Hospital
Division name	Orthopaedic Surgery
Address	9-1 Akashi-cho, Chuo-ku, Tokyo, 104-8560 Japan
TEL	+81-3(3541)5151
Email	s8058@nms.ac.jp

Public contact
Name of contact person	Masayoshi Saito, Atsushi Tasaki, Sachiyuki Tsukada
Organization	St. Luke's International Hospital
Division name	Orthopaedic Surgery
Address	9-1 Akashi-cho, Chuo-ku, Tokyo, 104-8560 Japan
TEL	+81-3(3541)5151
Homepage URL
Email	s8058@nms.ac.jp

Sponsor
Institute	St. Luke's international hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 11 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 13 Day
Anticipated trial start date	2014 Year 12 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 13 Day
Last modified on	2017 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018233