UMIN-CTR Clinical Trial

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