UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038865 |
|---|---|
| Receipt number | 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 10:48:41 |
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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
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
may335@naver.com
Sponsor or person
Institute
Korea University Anam Hospital
Gachon University Gil Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044322
