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Comparison between superior trunk block and interscalene brachial plexus block on the occurrence of hemidiaphragmatic paresis for right-sided arthroscopic shoulder surgery

Status Approved

First Submitted Date

2018/03/27
Registered Date

2018/05/18
Last Updated Date

2018/11/19

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002881
Unique Protocol ID	2018-02-008-001
Public/Brief Title	Comparison between superior trunk block and interscalene brachial plexus block on the occurrence of hemidiaphragmatic paresis for right-sided arthroscopic shoulder surgery
Scientific Title	Comparison between superior trunk block and interscalene brachial plexus block on the occurrence of hemidiaphragmatic paresis for right-sided arthroscopic shoulder surgery
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2018-02-008-001
Approval Date	2018-03-26
Institutional Review Board Name	Samsung Medical Center, Institutional Review Board
Institutional Review Board Address	81, Irwon-ro, Gangnam-gu, Seoul
Institutional Review Board Telephone	02-3410-2973
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Justin Sangwook Ko
Title	Associate professor
Telephone	+82-2-3410-2470
Affiliation	Samsung Medical Center
Address	81 ilwonro, gangnam gu, seoul
Contact Person for Public Queries
Name	RyungA Kang
Title	Assistant professor
Telephone	+82-2-3410-2470
Affiliation	Samsung Medical Center
Address	81 ilwonro, gangnam gu, seoul
Contact Person for Updating Information
Name	RyungA Kang
Title	Assistant professor
Telephone	+82-2-3410-2470
Affiliation	Samsung Medical Center
Address	81 ilwonro, gangnam gu, seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2018-04-25 Actual
Target Number of Participant	64
Primary Completion Date	2018-11-06 , Actual
Study Completion Date	2018-11-19 , Actual
Name of Study	Samsung Medical Center
Recruitment Status	Completed
Date of First Enrollment	2018-04-25 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Samsung Medical Center
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Interscalene brachial plexus block is widely used to provide anesthesia for arthrocopic shoulder surgery. The incidence of hemidiaphragmatic paresis following this technique can reach 90%. Possible mechanisms include direct spread of local anesthetic to the phrenic nerve or retrograde diffusion to the C3 to C5 nerve roots. Although transient hemidiaphragmatic paresis is well tolerated in healthy individuals, patients with preexisting pulmonary disease may suffer from respiratory complications. Recent care report suggests that superior trunk block can reduce the incidence of hemidiaphragmatic paresis. Thus, we set out to compare the incidence of hemidiaphragmatic paresis in patients between the superior trunk block and interscalene brachial plexus block.

Study Summary Information

Lay Summary

Interscalene brachial plexus block is widely used to provide anesthesia for arthrocopic shoulder surgery. The incidence of hemidiaphragmatic paresis following this technique can reach 90&#37;. Possible mechanisms include direct spread of local anesthetic to the phrenic nerve or retrograde diffusion to the C3 to C5 nerve roots. Although transient hemidiaphragmatic paresis is well tolerated in healthy individuals, patients with preexisting pulmonary disease may suffer from respiratory complications. Recent care report suggests that superior trunk block can reduce the incidence of hemidiaphragmatic paresis. Thus,  we set out to compare the incidence of hemidiaphragmatic paresis in patients between the superior trunk block and interscalene brachial plexus block.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject, Outcome Accessor
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	1) Interscalene brachial plexus block: local anesthetics are injected between C5 and C6 nerve roots 2) Superior trunk block: local anesthetics are injected into superior trunk.
Number of Arms	2
Arm 1	Arm Label Group I
	Target Number of Participant 34
	Arm Type No intervention
	Arm Description 1) Interscalene brachial plexus block: local anesthetics are injected between C5 and C6 nerve roots
Arm 2	Arm Label Group S
	Target Number of Participant 34
	Arm Type Experimental
	Arm Description 2) Superior trunk block: local anesthetics are injected into superior trunk.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M75.9)Shoulder lesion, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~70Year
	Description Adult(>19 years) Patients undergoing Right-sided arthroscopic shoulder surgery American Society of Anesthesiologist physical status I,II,III
Exclusion Criteria	American Society of Anesthesiologist physical status >IV Child(<18 years) Old age(>70 years) Pregnancy DIabetes Coagulopathy Cardiac disease, cerebrovascular disease, Infection, infection on skin, chronic pain disorder neuropathy affecting the brachial plexus Chronic pain disorder Patient refusal Drug allergy Patients with pshychiatric disease Patients with pulmonary disease (asthma, COPD, Tb, lung cancer, pneumonia)
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Safety
Outcome	The incidence of hemidiaphragmatic paresis
Timepoint	30 min after blockade
Secondary Outcome(s) 1
Outcome	duration of analgesia
Timepoint	Time to first pain at surgical site

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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