The effect of injectable lidocaine with and without topical lidocaine P ointment on pain, spasm and vasovagal syndrome in patients undergoing radial artery angiography
Determining the effect of injectable lidocaine with and without topical lidocaine P ointment on pain, spasm and vasovagal syndrome in patients undergoing angiography through radial artery
Design
randomized controlled clinical trial on 80 patients, A randomized, single-blind.
A random number table will be used for randomization.
Settings and conduct
It makes sense to use a non-injectable topical drug to achieve the desired anesthesia for the therapist. The aim of this study was to evaluate the effect of lidocaine injection with and without lidocaine p ointment on radial artery catheterization. Shahid Modarres Hospital, Tehran. Patients will be randomly divided into study and control groups. All patients will be unaware of the content of the ointment used.
Participants/Inclusion and exclusion criteria
Patients over 18 years
Allen normal test
No Raynaud's disease
Satisfaction with the research
exclusion criteria: History of ointment allergy, structural disorders such as wrist surgery, having a fistula in the hand, having a weak pulse, having a high INR
Intervention groups
Patients will be randomly divided into case groups (receiving lidocaine-Pi and subcutaneous injection of lidocaine) and control (subcutaneous injection of lidocaine without ointment).
Main outcome variables
Pain score; Incidence of spasm; Temperature; Incidence of the vasovagal syndrome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210829052318N1
Registration date:2022-05-24, 1401/03/03
Registration timing:retrospective
Last update:2022-05-24, 1401/03/03
Update count:0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Behrang Bahreini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3422 4499
Email address
behrang.behrang86.bb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2021-12-25, 1400/10/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of injectable lidocaine with and without topical lidocaine P ointment on pain, spasm and vasovagal syndrome in patients undergoing radial artery angiography
Public title
The effect of lidocaine on pain, spasm and vasovagal syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No Arthropathy in the upper extremities
Allen normal test
No Raynaud's disease
No Q wave infarction in the past week
No history of contrast agent allergy
Satisfaction with the research
people over 18 years old
Exclusion criteria:
History of allergies to this ointment
History of structural disorders such as wrist surgery
Having a weak pulse
Having a high INR
History of fistula in hand
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Step 1: Create a random sequence. A simple random method in which randomization is based on a single sequence of random allocations. The method of randomization is a table of random numbers. The researcher first determines the table to read the numbers (for example, right), then the numbers will be considered for different groups (for example, even numbers for intervention A and odd numbers for intervention B), then the researcher on one It gives up numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups.
Step 2: Hide the allocation: Use randomly coded boxes: In these boxes, the intervention or the sheets in which the random allocation is registered will be used.
Step 3: Execute the random allocation process: In order to create a random sequence, the participants will be examined in terms of entry and exit criteria and their names will be registered and the participants will be assigned to groups separate from the researchers.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, all eligible patients will be unaware of the contents of the ointments used and applied and the effects of the ointment, and the ointment tube will be covered by a cover.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
District 7, Madani St., Shemirani Alley, No. 60, first floor
City
Tehran
Province
Tehran
Postal code
1617745711
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.1048
Health conditions studied
1
Description of health condition studied
Coronary angiography patients through radial artery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score according to the patient's statement and based on VAS
Timepoint
During angiography
Method of measurement
Patient statement based on Visual analogue scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with topical cream (lidocaine / prilocaine) under the brand name Zila-P in patients undergoing angiography. Each 100 grams contains: 2.5 grams of lidocaine and 2.5 grams of prilocaine. Produced by Tehran Shimi Pharmaceutical Company. At a rate of 3 grams and put padded glue on it
Category
Treatment - Drugs
2
Description
Control group: Patients who did not use any ointment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behrang Bahreini
Street address
Nizamabad St., Madani St., Shemirani Alley, No. 60, first floor
City
Tehran
Province
Tehran
Postal code
1617745711
Phone
+98 914 165 0616
Email
behrang.behrang86.bb@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
District 7, Madani St., Shemirani Alley, No. 60, first floor
City
Tehran
Province
Tehran
Postal code
1617745711
Phone
+98 914 165 0616
Email
behrang.behrang86.bb@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?