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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011561
Receipt No. R000013525
Scientific Title The post-operation analgesia effects of brachial plexus block in shoulder arthroscopy surgery
Date of disclosure of the study information 2013/08/25
Last modified on 2019/07/07

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Basic information
Public title The post-operation analgesia effects of brachial plexus block in shoulder arthroscopy surgery
Acronym The post-operation analgesia effects of brachial plexus block in shoulder arthroscopy surgery
Scientific Title The post-operation analgesia effects of brachial plexus block in shoulder arthroscopy surgery
Scientific Title:Acronym The post-operation analgesia effects of brachial plexus block in shoulder arthroscopy surgery
Region
Japan

Condition
Condition patients who have shoulder arthroscopy surgery
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Shoulder Arthroscopy surgery is accompanied with severe shoulder joint pain due to muscle spasm.
We perform brachial plexus block in addition to general anesthesia for post-operation analgesia.
In this study, we reexamine the effectiveness of these post-operation analgesia procedures
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS(Visual Analogue Scale), side effects(numbness, nausea, vomiting)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 1.Received shoulder arthroscopy
2.20 years old or older
3.ASA physical status 1 or 2
4.Patients who agreed to participate in the study and signed informed consent form
Key exclusion criteria 1.Patients with severe respiratory disease
2.Other patients considered to be ineligible to participate in the study by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kumiko
Middle name
Last name Tanabe
Organization Gifu University Hospital
Division name Department of Anesthesiology&Pain Medicine
Zip code 5011194
Address 1-1 Yanagido, Gifu City, Gifu, 501-1194
TEL 058-230-6404
Email kumiko-t@m2.gyao.ne.jp

Public contact
Name of contact person
1st name Keishu
Middle name
Last name Hayashi
Organization Gifu University Hospital
Division name Department of Anesthesiology&Pain Medicine
Zip code 5011194
Address 1-1 Yanagido, Gifu City, Gifu, 501-1194
TEL 058-230-6404
Homepage URL
Email hayashiw@gifu-u.ac.jp

Sponsor
Institute Gifu University Hospital
Department of Anesthesiology&Pain Medicine
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)

IRB Contact (For public release)
Organization The Institutional Review Board for Clinical Research of Gifu University
Address 1-1 Yanagido, Gifu City, Gifu
Tel 058-230-6059
Email rinri@gifu-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 岐阜大学医学部付属病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 30
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 Completed
Date of protocol fixation
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We record the post-operation analgesia(VAS;Visual Analogue Scale) and side effects(numbness, nausea, vomiting) of brachial plexus block in shoulder arthroscopy surgery.

Management information
Registered date
2013 Year 08 Month 23 Day
Last modified on
2019 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013525

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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