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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000035443
Receipt No. R000040372
Scientific Title Evaluation of the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block in patients undergoing shoulder arthroplasty.
Date of disclosure of the study information 2020/01/04
Last modified on 2020/07/06

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Basic information
Public title Evaluation of the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block in patients undergoing shoulder arthroplasty.
Acronym Evaluation of the analgesic efficacy of intra-operative nerve block in patients undergoing shoulder arthroplasty.
Scientific Title Evaluation of the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block in patients undergoing shoulder arthroplasty.
Scientific Title:Acronym Evaluation of the analgesic efficacy of intra-operative nerve block in patients undergoing shoulder arthroplasty.
Region
Japan

Condition
Condition Patient who undergoing shoulder arthroplasty
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Compare the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block with interscalene block in patients who undergoing shoulder arthroplasty.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Post-operative pain(Visual analog scale, Numerical rating scale)
Key secondary outcomes Duration of anesthesia, the use of rescue analgesia, the frequency of nausea and vomiting, the presence of respiratory distress, the presence of paresthesia, other nerve block complication, post-operative shoulder flexion angle, evaluation of strength of elbow flexion and extension using Manual Muscle Testing (MMT), grip strength.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Supurascapular nerve block and axillary nerve block
Interventions/Control_2 Interscalene 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

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing primary hemiarthroplasty, total shoulder arthroplasty, reverse total shoulder arthroplasty.
Key exclusion criteria The case where no preoperative consent is obtained.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Yasuhara
Middle name
Last name Arashiro
Organization Fukuoka University Faculty of Medicine
Division name Dept.of Orthop.Surg
Zip code 8140180
Address 7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL 092-801-1011
Email md180001@cis.fukuoka-u.ac.jp

Public contact
Name of contact person
1st name Yasuhara
Middle name
Last name Arashiro
Organization Fukuoka University Faculty of Medicine
Division name Dept.of Orthop.Surg
Zip code 8140180
Address 7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL 092-801-1011
Homepage URL
Email md180001@cis.fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Faculty of Medicine
Dept.of Orthop.Surg
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukuoka University
Address 7-45-1 Nanakuma Jonan-ku, Fukuoka-shi, Fukuoka-ken
Tel 0928011011
Email fumed-ethics@fukuoka-u.ac.jp

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
2020 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 4
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2019 Year 01 Month 04 Day
Date of IRB
2019 Year 03 Month 06 Day
Anticipated trial start date
2019 Year 01 Month 09 Day
Last follow-up date
2020 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 04 Day
Last modified on
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040372

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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