Investigating the effect of adductor canal block in comparison with femoral nerve block for pain control in anterior cruciate ligament repair patients.
Determining the effect of adductor canal block in comparison with femoral nerve block for pain control in anterior cruciate ligament repair patients.
Design
Clinical trial with two groups, the first group: femoral nerve block, the second group: adductor canal block
It was double-blind and randomized by phase 3 lottery method on 84 patients
Settings and conduct
This study will be conducted on all patients who are candidates for elective arthroscopic knee surgery visiting Imam Khomeini Hospital in Urmia in 2023.
Then these patients will be randomly divided into 2 groups with equal numbers by lottery method.
First, the level of pain and satisfaction of the patients in two groups at zero hour, i.e. during recovery, was recorded by a pain level control questionnaire, and then the level of pain and satisfaction of the patients at 3 hours, and also at 6, 12, and 24 hours after the block by a single person. will be done
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with the classification of the Society of Anesthesiology with ASA I, II, age between 20 and 60 years.
Non-entry criteria: drug addiction, previous neuropathy
Intervention groups
First group: femoral nerve block, second group: adductor canal block
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056613N6
Registration date:2023-11-27, 1402/09/06
Registration timing:registered_while_recruiting
Last update:2023-11-27, 1402/09/06
Update count:0
Registration date
2023-11-27, 1402/09/06
Registrant information
Name
aliakbar nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
nasiriali7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-02, 1402/03/12
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adductor canal block in comparison with femoral nerve block for pain control in anterior cruciate ligament repair patients.
Public title
Investigating the effect of adductor canal block in comparison with femoral nerve block for pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for knee anterior cruciate ligament repair
Patients with the classification of the Society of Anesthesia with ASA I, II
No drug addiction
Exclusion criteria:
Coagulation disorders
Injection site infection
Neurological disorders
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups in a simple random manner using the numbers given by "Random Allocation" computer software. The randomization method is such that each patient is given a code and then the codes are written on a piece of paper, and after mixing the pieces of paper together, a piece of paper is randomly taken out each time and the code is related to the patient. In a list, the first 40 codes will be in the case group and the second 40 will be in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The procedure will be performed blindly and without the knowledge of the patients and the surgeon, so the study will be double-blind. Also, with the advice of a pharmaceutics expert, the pharmaceutical forms of the two groups will be designed the same.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-01-15, 1401/10/25
Ethics committee reference number
IR.UMSU.HIMAM.REC.1402.019
Health conditions studied
1
Description of health condition studied
Damage to the anterior cruciate ligament of the knee
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
0،24،48،72 hour
Method of measurement
Visual Analog Scale for Pain (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: femoral nerve block, in this group, 10 ml of bupivacaine 0.125% will be used for the block
Category
Treatment - Drugs
2
Description
Intervention group: adductor canal block, 10 ml of bupivacaine 0.125% will be used in the intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Urmia
Full name of responsible person
Farzaneh Ebrahimi
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 139 0408
Email
farzanehebrahimi1377@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Saber Qolizadeh
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 139 0408
Email
farzanehebrahimi1377@gamil.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Oroumia University of Medical Sciences
Full name of responsible person
Farzaneh Ebrahimi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 139 0408
Email
farzanehebrahimi1377@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ali nasiri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 139 0408
Email
nasiriali@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Farzaneh Ebrahimi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emergency Alley , Resalat Boulevard, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
004432234897
Email
farzanehebrahimi1377@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
A part of the data that is not confidential and personal
When the data will become available and for how long
Access starts from the beginning of 2023
To whom data/document is available
Researchers working in institutions
Under which criteria data/document could be used
Type of analysis
From where data/document is obtainable
Farzaneh Ebrahimi
What processes are involved for a request to access data/document
Please provide me with the data related to anterior cruciate ligament repair patients