The Effectiveness of topical anesthesia in the prevention of radial artery spasm and pain reduction before transradial approach coronary angiography
Design
Two arm parallel group randomised, Double blinded clinical trial with 200 patients. For randomization, permutation block stratified randomization method was used.
Settings and conduct
This randomized study will be performed on 200 women Angiography candidates in the Ali Ibn Abitaleb Hospital in Zahedan. patients will be divided into the two intervention and Control groups. The data collection tool is through a data collection checklist and Clinical observations. In this double blinded clinical trial with control group, randomization will be performed by permutation block method.
Participants/Inclusion and exclusion criteria
Inclusion Citeria: Candidates for radial Angiography؛ Over 18 years old
؛ Exclusion Citeria History of same side Angiography in previous Procedures ؛ Reynaud Syndrome؛ ESRD؛ Allergy to topical Analgesic؛ Lack of Radial Pulse؛ patient`s dissatisfaction to participate in the study
Intervention groups
Intervention group: 2.5 gram of therapeutic ointment Xyla-P is applied to the wrist overlying radial pulse (centered 1 cm proximal to the radial styloid process) half an hour before arterial puncture.
Control group: 2.5 gram of Placebo ointment is applied to the wrist overlying radial pulse (centered 1 cm proximal to the radial styloid process) half an hour before arterial puncture.
Main outcome variables
The Visual Analogue Scale (VAS) ؛ The occurrence of spasm following radial angiography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120817010617N9
Registration date:2022-11-04, 1401/08/13
Registration timing:prospective
Last update:2022-11-04, 1401/08/13
Update count:0
Registration date
2022-11-04, 1401/08/13
Registrant information
Name
morteza Sedaghat Kia
Name of organization / entity
zaums
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 9540
Email address
morimedico@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of topical anesthesia in the prevention of radial artery spasm and pain reduction before transradial approach coronary angiography
Public title
Effect of topical anesthesia in transradial approach coronary angiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for radial Angiography
Over 18 years old
Exclusion criteria:
History of same side Angiography in previous Procedures
Reynaud Syndrome
ESRD
Allergy to topical Analgesic
Lack of Radial Pulse
patient`s dissatisfaction to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to two groups will be done by permutation block stratified randomization method. Eligible patients will be classified respectively. based on 10 blocks (consisting of two groups A and B and two repetitions for each) patients will be randomly selected from all possible modes of permutations, and will be assigned to the desired group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this clinical trial, the Double Blinding method will be used. So that the Patients and practitioners will not be aware of the intervention. and the nurse is in charge of the patient`s analgesics without the knowledge of the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr.Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2022-08-28, 1401/06/06
Ethics committee reference number
IR.ZAUMS.REC.1401.199
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
The Visual Analogue Scale (VAS)
Timepoint
After Angiography
Method of measurement
Visual Analogue Scale checklist
2
Description
The occurrence of spasm following radial angiography
Timepoint
During the Angiography Procedure
Method of measurement
See the patient's angiogram during the procedure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2.5 gram of therapeutic ointment Xyla-P (Iranian Tehran Chemie inc.) is applied to the wrist overlying radial pulse (centered 1 cm proximal to the radial styloid process) half an hour before arterial puncture.
Category
Prevention
2
Description
Control group: 2.5 gram of Placebo ointment is applied to the wrist overlying radial pulse (centered 1 cm proximal to the radial styloid process) half an hour before arterial puncture.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-ebn Abi Taleb Hospital, Zahedan
Full name of responsible person
Neda Ehsan Zade
Street address
Zahedan Ali-ebn Abi Talib Hospital, Salamat boulevard, Dr.Hesabi square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
n.ehsanzade@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nour Mohammad Bakhshani
Street address
Dr Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Neda Ehsan Zade
Position
Cardiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Hesabi sq.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817843159
Phone
+98 54 1244 9540
Fax
Email
n.ehsanzade@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Neda Ehsan Zade
Position
Cardiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Hesabi sq.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817843159
Phone
+98 54 3344 9540
Fax
+98 54 1244 9540
Email
morimedico@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Neda Ehsan Zade
Position
Cardiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Hesabi sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817843159
Phone
+98 54 3344 9540
Email
morimedico@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available