Evaluation of the efficacy of topical lidocaine on radial spasm in patients underwent trans-radial angiography
Design
Phase 2 randomized double-blinded placebo parallel clinical trial on 276 patients Randomization using Randomaization.com
Settings and conduct
This study will perform in the heart ward of Ghaem Hospital in Mashhad. Patients are randomly assigned to Lidocain and placebo groups. Patients and the main researcher are unaware of groups assignation.
Participants/Inclusion and exclusion criteria
Patients who underwent trans-radial angiography; Consent to admission to the study; Age over 18 years
Intervention groups
Intervention group: Patients who underwent trans-radial angiography and topical Gel of Lidocain will be applied 30 minutes before PCI.
Placebo group: Patients who underwent trans-radial angiography and topical Gel of placebo will be applied 30 minutes before PCI.
Main outcome variables
Radial artery spasm during procedure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054874N7
Registration date:2022-12-07, 1401/09/16
Registration timing:prospective
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
Vafa Baradaran Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2301
Email address
baradaranrv@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of topical lidocaine on radial spasm in patients underwent trans-radial angiography
Public title
Efficacy of topical lidocaine on radial spasm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent radial angiography
Consent to admission to the study
Age more than 18 years old
Exclusion criteria:
Allergy to topical lidocaine
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
276
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used.
The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 69 blocks according to the sample size of 276. Then random numbers between 1 and 69 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Using sealed envelopes
Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of School of Medicine, Mashhad University of Medical Sciences
Street address
Faculty of Medicine, Ferdowsi University complex, Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.454
Health conditions studied
1
Description of health condition studied
Angina pectoris
ICD-10 code
I20
ICD-10 code description
Angina pectoris
Primary outcomes
1
Description
The incidence of radial artery spasm
Timepoint
During angioplasty
Method of measurement
Radial artery spasm score: A) Verbal or nonverbal expression of discomfort in the forearm during catheter/sheath manipulation: Absent: 0; Present: 1; B) Difficulty in manipulating the catheter: Absent: 0; Present: 1; C) Difficulty in sheath removal: Absent: 0; Present: 1; D) Additional use of intraarterial vasodilator for suspected radial artery spasm: No: 0; Yes: 1. Incidence of radial artery spasm indicated by a Radial artery spasm score of 1 or more.
Secondary outcomes
1
Description
Patient pain
Timepoint
During radial canulation
Method of measurement
According to the VAS scale (0-10; 0 is the least and 10 is the most pain)
2
Description
Sympathetic system response
Timepoint
Before and after angioplasty
Method of measurement
Measuring of systolic blood pressure, diastolic blood pressure and heart rate
Intervention groups
1
Description
Intervention group: Patients who underwent trans-radial angiography and 1 gram of lidocaine gel is applied to the wrist overlying radial pulse (centered approximately 1 cm proximal to the radial styloid process) 30 minutes before arterial puncture.
Category
Treatment - Drugs
2
Description
Control group: Patients who underwent trans-radial angiography and 1 gram of placebo gel is applied to the wrist overlying radial pulse (centered approximately 1 cm proximal to the radial styloid process) 30 minutes before arterial puncture.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
Dr. Mostafa Dastani
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3801 2739
Email
DastaniM@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour-Mobarhan
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
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