Evaluation of the effect of adding dexamethasone to lidocaine in digital finger block in patients referred to the operating room of AJA 501 hospital
Design
This study is a double blind RCT (clinical trial) on 60 patients randomly assigned using black and white cards in two parallel groups (30 people in each group), so that patients with black card to group one , And patients with white cards are assigned to group two and this process is repeated again.
Settings and conduct
Patients aged 20-60 years who have referred to the operating room of 501 AJA Hospital for finger surgery. After the operation and in the operating room recovery, the studied variables are recorded in the relevant questionnaire by the person in charge of collecting information who does not know the content of the syringes in the two groups.
Participants/Inclusion and exclusion criteria
All patients aged 20 to 60 years and ASA I who refer to the operating room of 501 Aja Hospital in Tehran electively or urgently from the time the plan is approved to perform surgery on one of the fingers and consciously sign the written consent form to participate in the research plan. Non-entry conditions: People with a history of allergies to local anesthetics - Pregnant women - People with a history of diabetes or uncontrolled liver and kidney disease - People with hemodynamic instability - People with a history of peptic ulcer - People on long-term treatment with corticosteroids.
Intervention groups
Depending on the color of the patient's black or white card, 3 cc of 2% lidocaine plus 1 cc (equivalent to 4 mg) of dexamethasone or 3 cc of 2% lidocaine plus 1 cc of distilled water is filled. The finger becomes relevant and starts 10 minutes after the surgeon performs the surgical block
Main outcome variables
1- FPP (free pain period)
2- Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110103005536N9
Registration date:2020-09-24, 1399/07/03
Registration timing:registered_while_recruiting
Last update:2020-09-24, 1399/07/03
Update count:0
Registration date
2020-09-24, 1399/07/03
Registrant information
Name
Mohamadreza Rafiei
Name of organization / entity
Artesh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8933
Email address
mo_rafiei@armyums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding dexamethasone to lidocaine in digital block in patients referred to the operating room of AJA 501 hospital
Public title
Evaluation of the effect of adding dexamethasone to lidocaine in digital block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients 20 to 60 years
ASA |
Exclusion criteria:
History of allergy to local anesthetic
pregnancy
People with a history of diabetes or uncontrolled liver and kidney disease
People with hemodynamic instability
people with history of peptic ulser
People on long-term treatment with corticosteroids.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned by sampling method and using black and white cards are divided between the two groups (30 people in each group), so that patients with black card are assigned to group one, and patients with white card are assigned to group two. Given and this process is repeated again
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, neither the patient nor the collector knew how the samples were distributed. The obtained information is then statistically analyzed by the person in charge of statistical work who does not know how the patients are distributed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of aja univercity of medical sciences
Street address
Etemadzadeh St. , West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
8158177365
Approval date
2016-08-01, 1395/05/11
Ethics committee reference number
IR.AJAUMS.REC.1395.11
Health conditions studied
1
Description of health condition studied
Digital nerve block
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
FPP (Free Pain Period)
Timepoint
When the patient requests an analgesic
Method of measurement
Duration of the patient's analgesic period in hours
2
Description
Intensity of pain
Timepoint
During the intervention
Method of measurement
According to the instruction given to all patients on how to express pain intensity according to the equivalent of visual equivalent (Visual Analogue Scale) through a 100 mm ruler, patients express their pain intensity as grade I≤30 (mild pain) and grade <30 II≤70 (Moderate pain) Grade III is divided into <70 (severe pain)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In one group,depending on the color of the patient's black or white card, participating in the project of 3 cc of 2% lidocaine plus 1 cc (equivalent to 4 mg) of dexamethasone, a digital finger block is performed and 10 minutes after the block Surgery is started by a surgeon
Category
Treatment - Drugs
2
Description
Intervention group:In one group,depending on the color of the patient's black or white card, participating in the project, 3 cc of 2% lidocaine plus 1 cc of distilled water will perform a digital finger block and 10 minutes after the surgical block, the surgeon will start the operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
501AJA hospital
Full name of responsible person
Dr. Mohammadreza rafiei
Street address
Etemadzadeh St. , West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 6350 8609
Email
mo_rafiei@armyums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Saeed Soleyman Meygooni
Street address
Etemadzadeh st. ,West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 6350 8609
Email
mo_rafiei@armyums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Mohamadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh street. West fatemi
City
Tehran
Province
Tehran
Postal code
8158177365
Phone
+98 21 8802 8933
Fax
+98 31 1263 1587
Email
mo_rafiei@armyums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohamadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh St. West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
8158177365
Phone
+98 21 8802 8933
Fax
+98 31 1263 1587
Email
mo_rafiei@armyums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohamadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh St. West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
8158177365
Phone
+98 21 8802 8933
Fax
+98 31 1263 1587
Email
mo_rafiei@armyums.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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after being unidentified
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
All researchers and colleagues in this field
Under which criteria data/document could be used
For therapeutic and research purposes and by mentioning the names of the authors of the article
From where data/document is obtainable
Dr. Mohammadreza rafiei
What processes are involved for a request to access data/document
Send email to Dr. Mohammad Reza Rafiei and receive data and documents if needed in the shortest time