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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038865
Receipt No. R000044322
Scientific Title A comparison of anesthetic quality and complication between ultrasound guided interscalene block and superior trunk block in arthroscopic shoulder surgery
Date of disclosure of the study information 2020/04/27
Last modified on 2020/04/27

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Basic information
Public title A comparison of anesthetic quality and complication between ultrasound guided interscalene block and superior trunk block in arthroscopic shoulder surgery
Acronym Interscalene block vs. superior trunk block
Scientific Title A comparison of anesthetic quality and complication between ultrasound guided interscalene block and superior trunk block in arthroscopic shoulder surgery
Scientific Title:Acronym Interscalene block vs. superior trunk block
Region
Asia(except Japan)

Condition
Condition arthroscopic shoulder surgery
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 interscalene nerve block remains the most commonly used peripheral nerve block for shoulder surgery. Alternative to sparing the phrenic nerve, superior trunk block also can be used. We want to compare the block quality and complication like diagphragmatic paralysis between these two blocks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes change in diaphragmatic movement in perioperative period.
Key secondary outcomes success rate (excellent, good,insufficient, fail, rate of complete sensory blockade of operative site (shoulder to upper humerus area), the onset time (time required to obtain of a sensory block at the surgical incision site)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Interventions: superior trunk block
21G, 68mm E-cath needle (Pajunk)
Nerve stimulator
GE ultrasound
Interventions/Control_2 Control: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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria all patients anticipating arthroscopic shoulder surgery, age: 18 to 80 years, American Society of Anesthesiologists physical status (ASA)I to II
Key exclusion criteria neuropathy in the operated limb, coagulation disorders, known allergy to local anesthetics, local infection at the puncture site, chronic obstructive pulmonary disease or respiratory failure, pregnancy or breast feeding,prior surgery in the supraclavicular region, obesity, uncooperative patients, patients' refusal
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Mi Geum
Middle name
Last name Lee
Organization Gachon University Gil Medical Center
Division name Department of Anesthesiology and Paind medicine
Zip code 21565
Address Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, South Korea
TEL 82-32-460-3636
Email mikeum2@gilhospital.com

Public contact
Name of contact person
1st name Hyeon Ju
Middle name
Last name Shin
Organization Korea University College of Medicine, Anam hospital
Division name The Anesthesiology and Pain medicine
Zip code 136-705
Address Department of Anesthesiology and Pain Medicine, College of Medicine, Korea University Address: #73 G
TEL +82-2-2286-1259
Homepage URL
Email may335@naver.com

Sponsor
Institute Korea University Anam Hospital
Gachon University Gil Medical Center
Institute
Department

Funding Source
Organization Korea University Anam Hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Korea University College of Medicine, Anam hospital
Address Department of Anesthesiology and Pain Medicine, College of Medicine, Korea University Address: #73 G
Tel +82-2-2286-1259
Email may335@naver.com

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 Dear UMIN authorities.
I have taken a UMIN number UMIN000038865 on Dec 12, 2019, which date is the date before the data was collected. This can be found by checking the time I first entered the data.

But I didn’t understand that the ‘Date of disclosure of the study information’ means ‘the date of trial registration’, so I had entered an invalid date I had entered the date with a sufficient period of time just in anticipation of the end of this study.
Honestly, the date of my trial registration is equal to the ‘Date of provisional registration’.
This is simply because I misunderstood English.
I sincerely ask you to be considerate of our situation.

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 27 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 48
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
2019 Year 12 Month 12 Day
Date of IRB
2019 Year 11 Month 25 Day
Anticipated trial start date
2019 Year 12 Month 12 Day
Last follow-up date
2020 Year 04 Month 08 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 12 Month 12 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044322

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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