Determination of the effect of isometric exercise and lidocaine 2% in reducing pain during propofol injection
Design
Clinical trial with control group, with parallel groups, blind, randomized
Settings and conduct
This is a randomized clinical trial. The study population consisted of 120 patients aged 20-60 years who are candidates for various surgeries at 22 Bahman Neishabour Hospital. Four- Point pain scale is used to evaluate pain. painless (0), low pain sensation (1), moderate pain (2), severe pain and with or without movement of the limbs and facial muscles (3 ). Patients are divided into groups A, B, and C, based on random allocation by random numbers table: In group C, each isometric exercise cycle consists of 3s of exercise and t3s of rest. In this study, the participants and the person evaluating pain intensity are blinded to the method of work.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
candidate for general anesthetic surgery
ages of 20-60
consent and willingness to participate in the research
ASA I, II
Not sensitive to the drugs studied
Having at least a fifth grade of elementary school
Ability to communicate with the research team
No addiction
Exit criteria:
Having Nervous-Muscular Diseases, heart disease ,history of seizures
Having metabolic and gastrointestinal disorders
Severe nervous and psychiatric disorders
Sedation and narcotics
Alcoholic patients
Sedative or analgesic
Need for induction of anesthesia and rapid intubation
ESRD
Liver disorders
Intervention groups
Group A: Propofol injections of 1% pure (control)
Group B: injection of propofol with 40 mg lidocaine 2% (intervention)
Group C: Perform 5 isometric exercise cycles and then administer 1% pure propofol (intervention).
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190109042309N1
Registration date:2019-02-06, 1397/11/17
Registration timing:prospective
Last update:2019-02-06, 1397/11/17
Update count:0
Registration date
2019-02-06, 1397/11/17
Registrant information
Name
Zohreh Mohamadzadeh Tabrizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8329
Email address
mohammadzadehz@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of isometric exercise and lidocaine 2% on pain relief during propofol intravenous injection
Public title
effect of isometric exercise on pain relief during propofol intravenous injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is a candidate for general anesthetic and surgery
The patient is between the ages of 20 and 60
The patient has the consent and willingness to participate in the research
American Society of Anesthesiology Class I, II
Having at least a fifth grade of elementary school
Ability to communicate with the research team
Exclusion criteria:
Not sensitive to the drugs studied
No addiction
Having Nervous-Muscular Diseases
Having heart disease and history of seizures
Having metabolic and gastrointestinal disorders
Severe nervous and psychiatric disorders
Class 3 and 4 American Anesthesiology Society
Need for induction of anesthesia and rapid intubation
Kidney disease in the final stage
Liver disorders
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
A person randomly assigns to one of the three study groups with using random number table and receive the intervention of the same group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and the person evaluating the outcome are blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Deputy Director of Research and Technology, University of Medical Sciences , Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9717913112-971791311
Approval date
2018-12-29, 1397/10/08
Ethics committee reference number
IR.MEDSAB.REC.1397.088
Health conditions studied
1
Description of health condition studied
Pain caused by injection of propofol
ICD-10 code
R52.9
ICD-10 code description
XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Primary outcomes
1
Description
Intensity of pain
Timepoint
At the time of induction of anesthesia
Method of measurement
Assessment of Pain Scores of 4-point Verbal Rating Scale (VRS) during Injection of Propofol
Secondary outcomes
empty
Intervention groups
1
Description
1. Intervention group: Perform isometric exercise before propofol injection
Category
Prevention
2
Description
2. Intervention group: Lidocaine injection 2% before propofol injection
Category
Prevention
3
Description
Control group: Propofol injection
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital in Neyshabour
Full name of responsible person
Mahdieh Anjidani
Street address
22 Bahman Hospital, Ave Emam, Neyshabour Town
City
Neyshabour
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4441 8369
Email
Razaviamir78@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zohreh Mohamadzadeh Tabrizi
Street address
Sabzevar University of Medical Sciences, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114- 96179131
Phone
+98 51 4401 8329
Email
mohamadzadehtz1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Zohreh Mohamadzadeh Tabrizi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Sabzevar University of Medical Sciences,Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114- 96179131
Phone
+98 51 4401 8329
Fax
Email
mohammadzadehz@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zohreh Mohamadzadeh Tabrizi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Sabzevar University of Medical Sciences,Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114- 96179131
Phone
+98 51 4401 8329
Fax
Email
mohammadzadehz@medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zohreh Mohamadzadeh Tabrizi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Sabzevar University of Medical Sciences,Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114- 96179131
Phone
+98 51 4401 8329
Fax
Email
mohammadzadehz@medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of the research are published
When the data will become available and for how long
Starting available 6 months after the publication of results
To whom data/document is available
Internal Scientists at Sabzevar University of Medical Sciences
Under which criteria data/document could be used
Just for reading
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document