Compromise of anesthesial time of lidocain and lidocain plus bicarbonate in one cm of laceration
Design
Randomized double parallel group trial with double blind injection of lidocain and lidocain plus bicarbonate in anesthesy of laceration belowe 10 cm and distal to knee and elbow
Settings and conduct
In patient that have laceration belowe 10 cm and distal knee and elbow that will recipte into khatam hospital of zahedan will inject lidocain which maybe have bicarbonate in double blind method and compromise two group in time of begining and period time of anesthesy
Participants/Inclusion and exclusion criteria
Patient with laceration belowe 10 cm and belowe knee and elbow without crush amputation severe bleeding and neurovascular injury
Intervention groups
Adding of bicarbonate in injection of lidocain in interventional group and injection of lidocain in control group
Main outcome variables
The time of begining and period time of anesthesy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190430043435N1
Registration date:2019-06-29, 1398/04/08
Registration timing:registered_while_recruiting
Last update:2019-06-29, 1398/04/08
Update count:0
Registration date
2019-06-29, 1398/04/08
Registrant information
Name
Islamic republic of iran Sargolzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3322 0501
Email address
farhadsargol@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of adding bicarbonate in anesthesial effect of lidocain
Public title
Increase anesthesial effect of lidocain with adding bicarbonate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laceration less than10 cm
Distal to elbow and knee
Exclusion criteria:
Neurovascular injury of DM or CHF or trauma
Crush and amputation
Massive bleeding
History of sensitivity to lidocain
Age
From 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking of patient with convenience sampling into 6 block 4some with used of random numbers tablet
Blinding (investigator's opinion)
Double blinded
Blinding description
Providing of half of vial of lidocain with add of bicarbonate that every patient use from one soluble and not only patient nor phisition know the kind of anesthetic drug, from injection to calculation of time of anesthesia ,of course we will get from all of patient the informed consent form and give them information from study for safty of study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Jamejam
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9654367867
Approval date
2018-06-17, 1397/03/27
Ethics committee reference number
IR.ZAUMS.REC.1397.151
Health conditions studied
1
Description of health condition studied
Laceraton belowe 10cm distal knee and elbow
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Local anesthetic time
Timepoint
First begining of anesthesia and end of it
Method of measurement
Timing of begining to end of it in assess of minute
Secondary outcomes
1
Description
Anesthesial begining time and end
Timepoint
Begining of local injection .begining of anesthesia.end of anesthesia
Method of measurement
In base of minute
Intervention groups
1
Description
In interventional group we inject from lidocain plus bicarbonate(10to1)in amount of one cc in one cm2 of lesion and we will find the time of begin and end of anesthesi with cronometer.
Category
Treatment - Drugs
2
Description
Control group:in contrl group we inject only lidocain into lesion in amount of one cc in one cm2 of lesion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan khatam hospital
Full name of responsible person
Dr jalal sargolzaei
Street address
Jamejam
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 3001
Email
Farhadsargol@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Jalal sargolzaei
Street address
jamejam
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
0943329809
Phone
+98 54 3322 1001
Email
farhadsargol@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Private
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
Zahedan University of Medical Sciences
Full name of responsible person
Jalal sargolzaei
Position
Assistant of emergency medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Jamejam
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۵۷۳۳۱۶۹
Phone
+98 0543223001
Email
Farhadsargol@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Jalal sargolzaei
Position
Assisstant of emergency medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Jamejam
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 0543223001
Email
Farhadsargol@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Jalal sargolzaei
Position
Assisstant of emergency medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Jamejam
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۵۷۳۳۱۶۹
Phone
+98 0543223001
Email
Farhadsargol@gmail.com
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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The time of anesthesia is the power of drug that used for procidure
When the data will become available and for how long
From end of study
To whom data/document is available
All of researching and industrial agent
Under which criteria data/document could be used
After reliable and reasonable results mean that bicarbonate add lidocain have increasing painless result
From where data/document is obtainable
The investigation responsible with address in irct
What processes are involved for a request to access data/document