Comparison of the effect of lidocaine and cold saline on reducing the pain of propofol injection
Design
A double-blind clinical trial with randomized groups with SPSS software is performed in phase 3 with a control group with a sample size of 120 people.
Settings and conduct
Ayatollah Rouhani Educational and Medical Center in Babol
In this study, both patients and researchers who recorded the severity of propofol injection pain were blinded.
Participants/Inclusion and exclusion criteria
Candidate patients for general anesthesia with propofol selected / entry criteria is patients of 18 to 60 years old with ASA class one and two and no entry with underlying heart disease, history of seizures, lidocaine sensitivity.
Intervention groups
Three groups of patients are candidates for general anesthesia receiving lidocaine, normal saline at 4 ° C and normal saline at room temperature.
Main outcome variables
Changes in amount of pain at the injection site of propofol.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141121020020N7
Registration date:2021-06-08, 1400/03/18
Registration timing:retrospective
Last update:2021-06-08, 1400/03/18
Update count:0
Registration date
2021-06-08, 1400/03/18
Registrant information
Name
Shahram Seyfi
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8284
Email address
sh.seyfi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-13, 1399/12/23
Expected recruitment end date
2021-05-13, 1400/02/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lidocaine and cold normal saline on pain during propofol injection
Public title
The effect of lidocaine and cold normal saline on injection pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Indication of propofol injection
Elective general anesthesia
Exclusion criteria:
Known heart disease
History of lidocaine sensitivity
Patient dissatisfaction
History of seizures
History of psychiatric illness
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by random blocks with block size of 6 and number of blocks of 20.
First, twenty random blocks of AABBCC letter permutations are generated by the randomization site and recorded in one sheet, respectively, and then the patients will be assigned to one of the three study groups according to the permutations generated.
The website address is WWW.RANDOMIZATION.COM.
The tab generated by the randomization site is a tab similar to the following table:
1.A
2.B
3.B
4.C
5.A
6.C
.
.
.
120.C
Then, each patient who is admitted is assigned to one of the groups according to the above sheet and the patient's entry and the desired number, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is generally explained to patients that they will receive one of the three drugs of study and patients fill and sign an informed consent form. Patients who are candidates for this study are divided into three groups of 40 for lidocaine injection, cold normal saline at 4 ° C, and normal saline at room temperature as the control group. The drugs are prepared in exactly the same packaging in terms of shape and size in 10 cc syringes with a unique 4-digit code. All drugs are injected by a trained anesthetist. After injecting the drugs, the anesthesiologist leaves the room without giving further information to the researcher.
In the informed consent form, the whole study process and the studied drugs are explained to the patient, but the patients are not aware of the drug they are receiving.
Placebo
Used
Assignment
Parallel
Other design features
Patients are randomly assigned to study groups by permutation block method. Medication is assigned by a nurse.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Ganj Afrouz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2020-08-31, 1399/06/10
Ethics committee reference number
IR.MUBABOL.REC.1399.426
Health conditions studied
1
Description of health condition studied
Pain at the injection site
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain severity at the injection site
Timepoint
At beginning, at 15 and 30 seconds after injection
Method of measurement
Questionnaire and VAS scoring scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lidocaine receiving group. Patients in this group receive 10 ml of 0.5% lidocaine as an intervention group.
Category
Prevention
2
Description
Intervention group: Recipient of normal saline 4 ° C. Patients in this group receive 10 ml of normal cold saline 4 ° C as an intervention group.
Category
Prevention
3
Description
Control group: Normal saline recipient with ambient temperature. Patients in this group receive 10 ml of normal saline at room temperature as a control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayattolah Rohani Hospital
Full name of responsible person
Shahram Seyfi
Street address
Ganj afrouz st.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Email
rohani@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Deputy of research and Technology of Babol university of medical sciences
Street address
Ganj afrouz st. Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Shahram Seyfi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ganj Afrouz st.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Email
sh.seyfi@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Shahram Seyfi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ganj afrouz st.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Email
sh.seyfi@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Shahram Seyfi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ganj afrouz st.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Email
sh.seyfi@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Raw and analyzed information obtained from all stages of the study
When the data will become available and for how long
unlimited
To whom data/document is available
All researchers with professional and ethical competence in the field of clinical affairs
Under which criteria data/document could be used
Provided there is no conflict of interest between the researchers, the responsible institution and the patients
From where data/document is obtainable
Vice Chancellor for Research, Babol University of Medical Sciences
mubabol.ac.ir
What processes are involved for a request to access data/document
This study will be conducted according to the administrative procedure of the licensing institution.