Evaluation of the effect of caudal block under ultrasound guide in controlling pain in children before and after knee osteotomy
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups.
Settings and conduct
50 patients were enrolled in the study and randomly divided into two groups of 25 patients. In all patients, the amount of pain is measured before the operation according to VAS criteria. The first intervention group, after induction and intubation under the caudal block, was placed in the lateral position with a dose of 0.5 cup / kg of 0.2% rupivacaine. In the second intervention group, the lateral block is injected in the lateral position after surgery and before extubation with a dose of 0.5 cp / kg of 0.2% rupivacaine. They are then reversed and extubated with neostigmine 0.04 mg / kg and atropine 0.02 mg / kg.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children undergoing knee osteotomy surgery
Exclusion criteria: Systemic infection, Infection of the needle insertion site, Coagulation disorder
Intervention groups
Intervention Group 1: After induction and intubation, they were placed in the lateral position under the caudal block at a dose of 0.5 cc / kg of 0.2% rupivacaine. Intervention Group 2: Catral block under lateral position after injection and before extubation with 0.5 cc / kg dose of 0.2% rupivacaine is injected. They are then reversed and extubated with neostigmine 0.04 mg / kg and atropine 0.02 mg/kg.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180723040570N6
Registration date:2022-01-14, 1400/10/24
Registration timing:prospective
Last update:2022-01-14, 1400/10/24
Update count:0
Registration date
2022-01-14, 1400/10/24
Registrant information
Name
Nasim Nikoubakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 9854
Email address
nikoobakht.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of caudal block under ultrasound guide in controlling pain in children before and after knee osteotomy
Public title
Effect of caudal block under ultrasound guide in controlling pain of knee osteotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children two to six years old are candidates for knee osteotomy surgery
Consent from parents
Exclusion criteria:
Coagulation disorder
Infection of the needle insertion site
Systemic infection
Age
From 2 years old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.
To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks.
For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit.
Here, based on the block, we divide 4 people into groups.
1. TTCC 2. TCTC 3. TCCT
4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-09-06, 1399/06/16
Ethics committee reference number
IR.IUMS.FMD.REC.1399.383
Health conditions studied
1
Description of health condition studied
Osteotomy
ICD-10 code
M92.8
ICD-10 code description
Other specified juvenile osteochondrosis
Primary outcomes
1
Description
Pain
Timepoint
Before and after surgery
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After induction and intubation, they were placed in the lateral position under the caudal block at a dose of 0.5 cp / kg of 0.2% rupivacaine.
Category
Treatment - Devices
2
Description
Intervention group: Catral block under lateral position is injected after surgery and before extubation with 0.5 cc / kg dose of 0.2% rupivacaine.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul-e Akram hospital
Full name of responsible person
Fatemeh Ahmadi
Street address
Nyayesh ST.Sattarkhan ST.Rasul-e Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 4001
Fax
+98 21 6650 6864
Email
Bahar.ahmadi69@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6651 4001
Fax
+98 21 6650 6864
Email
nnikobakht@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadi
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Nyayesh ST.Sattarkhan ST. Rasul-e Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 4001
Email
Bahar.ahmadi69@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadi hafshejani
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Nyayesh ST.Sattarkhan ST.Rasul-e Akram Hospital
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 6651 4001
Fax
+98 21 6650 6864
Email
Bahar.ahmadi69@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadi
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Valinejad Alley, Above Vanak Square, Vali Asr St
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Email
jhoseini2003@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
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
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data is shared after unidentifiable people.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Fatemeh Ahmadi
What processes are involved for a request to access data/document
En After reviewing the applicant's request, it will be sent to him.