Determining the effect of local anesthesia with lidocaine spray on pain control in patients undergoing radial coronary angiography
Design
A three-group clinical trial with a control group, with parallel groups, randomized with the participation of 228 patients. For randomization, permutation blocks of 6 will be used.
Settings and conduct
The present study will be conducted as a three-group clinical trial study with the participation of 228 patients who are candidates for coronary angiography in Bushehr City Heart Hospital in 2022. Patients will be randomly divided into three intervention and control groups using permutation blocks. In the control group, only injectable lidocaine will be used to anesthetize the needle entry area. In the first intervention group, in addition to injectable lidocaine, lidocaine spray will also be used. In the second intervention group, only lidocaine spray will be used to anesthetize the needle entry area.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ischemic heart disease confirmed by the attending physician, Performing radial angiography for the first time, Elective patients for angiography
Exclusion criteria: Sensitization to lidocaine skin spray, Lack of stability of vital signs during the procedure
Intervention groups
Intervention groups: The first intervention group (A) will receive 6 puffs of 10% lidocaine spray 5 minutes before the angiography from a distance of 5 cm around the inside of the wrist, and then they will receive injectable lidocaine and then proceed to angiography. The second intervention group (B) will receive 6 puffs of 10% lidocaine spray 5 minutes before the angiography from a distance of 5 cm from the inside of the wrist. On the contrary, the control group and the first test group will not receive injectable lidocaine.
Main outcome variables
Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N39
Registration date:2022-09-03, 1401/06/12
Registration timing:prospective
Last update:2022-09-03, 1401/06/12
Update count:0
Registration date
2022-09-03, 1401/06/12
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-21, 1401/06/30
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local anesthesia with lidocaine spray on the pain control of patients under radial coronary angiography
Public title
The effect of local anesthesia with lidocaine spray on the pain control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ischemic heart disease confirmed by the physician
Performing radial angiography for the first time
Elective patients for angiography
Exclusion criteria:
Lack of stability of vital signs before the procedure
Sensitization to lidocaine skin spray
Age
From 19 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
228
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected through available sampling based on the inclusion criteria. The samples will be randomly assigned to three groups (two intervention groups and one control group) using block randomization method such as AABBCC, ACCBAB.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2022-06-11, 1401/03/21
Ethics committee reference number
IR.UMSHA.REC.1401.266
Health conditions studied
1
Description of health condition studied
Coronary heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Pain severity
Timepoint
Immediately after entering the needle and 30 minutes later
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group(A): The first intervention group (A) will receive 6 puffs of 10% lidocaine spray 5 minutes before the angiography from a distance of 5 cm around the inside of the wrist, and then they will receive injectable lidocaine and then proceed to angiography.
Category
N/A
2
Description
Intervention group (B): The second intervention group receives 6 puffs of 10% lidocaine spray 5 minutes before angiography from a distance of 5 cm from inside the wrist. On the contrary, the control group and the first experimental group do not receive injectable lidocaine.
Category
N/A
3
Description
Control group: The control group will receive the usual anesthetic procedures before angiography, which includes 0.6-1 cc of lidocaine injection of 2% in the area around the styloid bone, and then they will pierce the radial artery with a #20 needle and place a 6-French arterial sheath and they will perform vascular angiography.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Boushehr heart hospital
Full name of responsible person
Asghar Bahrani
Street address
Boushehr heart hospital, Imam Khomeini Street.
City
Boushehr
Province
Boushehr
Postal code
38698-65178
Phone
+98 77 3333 2946
Email
asghar.bahrani@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokouhi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Sajad Ebrahimi
Position
Studentd
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sajjadebrahimi78@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
oshvandi2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sajad Ebrahimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sajjadebrahimi78@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