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Effect of cryoanagesic preparation before local anesthesia on pain scale in patients with suturing wound

Status Approved

First Submitted Date

2016/05/17
Registered Date

2016/07/29
Last Updated Date

2016/07/28

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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	KCT0001990
Unique Protocol ID	AJIRB-MED-BDR-16-020
Public/Brief Title	Effect of icing to wound before local anesthesia on pain scale
Scientific Title	Effect of cryoanagesic preparation before local anesthesia on pain scale in patients with suturing wound
Acronym	ECRP study
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	AJIRB-MED-BDR-16-020
Approval Date	2016-04-29
Institutional Review Board Name	Ajou University Hospital IRB
Institutional Review Board Address
Institutional Review Board Telephone
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	SangChun Choi
Title	M.D,
Telephone	+82-31-219-7750
Affiliation	Ajou University Hospital
Address	164 Worldcup-ro Yeongtong-gu Suwon Gyeonggi-do Republic of Korea
Contact Person for Public Queries
Name	SangChun Choi
Title	M.D,
Telephone	+82-31-219-7750
Affiliation	Ajou University Hospital
Address	164 Worldcup-ro Yeongtong-gu Suwon Gyeonggi-do Republic of Korea
Contact Person for Updating Information
Name	SangChun Choi
Title	M.D,
Telephone	+82-31-219-7750
Affiliation	Ajou University Hospital
Address	164 Worldcup-ro Yeongtong-gu Suwon Gyeonggi-do Republic of Korea

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	Recruiting
Date of First Enrollment	2016-05-17 Actual
Target Number of Participant	50
Primary Completion Date	2016-08-31 , Anticipated
Study Completion Date	2016-08-31 , Anticipated
Name of Study	Ajou University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-05-17 ,

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	Ajou University Hospital
Organization Type	Medical Institute
Project ID	AJIRB-MED-BDR-16-020

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Ajou University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Pain on local anesthetic injection is known to be unavoidale for suture procedure. However, the application of ice before local anesthetic injection may reduce the injection pain by local anesthetic agent. The purpose of this study is to investigate the cryoanalgesic effect of ice on pain scale in patients with wounds needing suture for local anestheia.

Study Summary Information

Lay Summary

Pain on local anesthetic injection is known to be unavoidale for suture procedure. However, the application of ice before local anesthetic injection may reduce the injection pain by local anesthetic agent. The purpose of this study is to investigate the cryoanalgesic effect of ice on pain scale in patients with wounds needing suture for local anestheia.

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	Treatment
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Others (the 2 minute application of ice to areas where local aensthetic agent will be injected )
Intervention Description	Two minutes application of sterile ice cube to the site where local aensthetic agent will be injected for experimental group.
Number of Arms	1
Arm 1	Arm Label Icing group
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description Two minutes application of sterile ice cube to the site where local anesthetic agent will be Injected and primary repair will be performed. Pain scale (NRS) will be checked for effect of reducing pain subject to ice cube application.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (S00-T98)Injury, poisoning and certain other consequences of external causes (T01.9)Multiple open wounds, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~65Year
	Description Subjects who undergo suture(s) within 30 minute procedure time
Exclusion Criteria	Unclear mental state Drunken state History of diabetes mellitus (DM), stroke, neurological diseases such as spinal cord injury or peripheral neuropathy History of receving or taking analgesic agent within 6 hour before suturing
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/Efficacy
Outcome	Pain scale
Timepoint	Shortly after injection of local anesthetics
Secondary Outcome(s) 1
Outcome	Complications
Timepoint	Stitching out and 1 month (if, needed)

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

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	Not provided at time of Registration

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