The Comparison between intraarticular knee injection (Morphine, , ketorolac) with and without Tranxamic acid following arthroscopic ACL reconstruction surgery in reducing pain and assessing functional outcomes in patient with isolated ACL injury
Comparing the effectiveness of intra-articular injection of morphine, ketorolac with and without injection
Tranexamic acid in reducing pain and short-term clinical outcome after arthroscopic reconstruction of anterior cruciate ligament in patients with exclusive injury of ACL
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 98 patients. For randomization, the random numbers given to each of them by the computer enter the control group or the intervention group.
Settings and conduct
Patients in Imam Khomeini Hospital, Tehran, after meeting the entry criteria and obtaining informed consent, will be divided into 2 control and intervention groups, according to the sample size.
Participants/Inclusion and exclusion criteria
Individuals with exclusive rupture of the ACL in the age range of 15 to 60 years and weighing <100 kg who are able to read and write to give written informed consent and cooperate in the study were included.
And people with drug sensitivity or a history of drug dependence who have neurological and psychiatric problems, heart, kidney, liver disease and cardiac arrhythmia, diabetes, neuromuscular disease, inflammatory joint arthritis such as rheumatoid arthritis, or performing osteotomy surgery or the presence of accompanying cartilage damage or meniscal tear, They are being excluded from the study
Intervention groups
Intervention group:
30mg Ketorolac ampoule(1cc)
5mg morphine sulfate(0.5cc)
1gr Tranexamic acid (10cc)
28.5cc of normal saline solution
Control group:
30mg Ketorolac ampoule(1cc)
5mg morphine sulfate(0.5cc)
38.5cc of normal saline solution
Main outcome variables
Reducing the amount of pain and increasing the satisfaction and rehabilitation of patients after arthroscopic reconstruction of the ACL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221230056983N1
Registration date:2023-02-25, 1401/12/06
Registration timing:registered_while_recruiting
Last update:2023-02-25, 1401/12/06
Update count:1
Registration date
2023-02-25, 1401/12/06
Registrant information
Name
Behzad Nezhadtabrizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1653
Email address
tabrizibehzad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison between intraarticular knee injection (Morphine, , ketorolac) with and without Tranxamic acid following arthroscopic ACL reconstruction surgery in reducing pain and assessing functional outcomes in patient with isolated ACL injury
Public title
Investigating the effectiveness of intra-articular injection painkillers after cruciate ligament surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Exclusive tear of the anterior cruciate ligament or ACL
Age more than 15 years and less than 60 years
Weight less than 100 kg
Ability to read and write to give informed written consent and cooperate in the study
Use of hamstring autograft
Exclusion criteria:
Drug sensitivity
History of drug dependence
Neurological and psychiatric problems, heart, kidney, or liver disease, and cardiac arrhythmia
Diabetes
Neuromuscular disease
Inflammatory joint arthritis such as rheumatoid arthritis
Use of allograft
Performing accompanying osteotomy surgery
Presence of accompanying cartilage damage or meniscal tear
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers (two block) by site randomization.com
Blinding (investigator's opinion)
Double blinded
Blinding description
In our study, both the patients and the researchers are blinded to the prescription of the intervention drug, and the surgeon simply divides the patients into 2 groups, with and without the prescription of the drug, based on the argument of random numbers
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Emam Khomeini Hospital, Orthopedic Department, Joint Reconstruction Research Center, Chamran Highway, Baqerkhan East Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2022-08-30, 1401/06/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.134
Health conditions studied
1
Description of health condition studied
isolated anterior cruciate ligament injury
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee
Primary outcomes
1
Description
pain variables including the amount of pain based on Visual Analogue Scale (VAS)
Timepoint
The pain level of the patients is based on the Visual Analoque Scale or VAS with a score from 1 to 10, which is measured in the intervals of one hour, two hours, 3 hours, 6 hours, 12 hours, 24 hours, one week, one month and three months after the operation.
Method of measurement
The level of patient satisfaction are measured based on the Visual Analogue Scale index
2
Description
Functional variables in patients including Lysholm
Timepoint
Lysholm questionnaire score from 0 to 100, before surgery, one hour, one month and three months after surgery.
Method of measurement
The performance of all patients is completed and evaluated based on the Lysholm questionnaire
3
Description
Functional variables in patients including Knee Injury and Osteoarthritis Outcome Score (KOOS).
Timepoint
It is measured before surgery, one month and three months after surgery.
Method of measurement
The score of the KOOS or Knee injury and Osteoarthritis Outcome Score questionnaire examines the patient in 5 areas and its score is 0 to 100%.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc), 38.5 cc of normal solution Saline; All made by Iranian pharmaceutical companies
Category
Treatment - Drugs
2
Description
Intervention group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc), 1 gram of tranexamic acid (TXA) (10 cc) 28.5 cc normal saline solution; All made by Iranian pharmaceutical companies
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital,Tehran,Iran
Full name of responsible person
Mohammad Ayati Firozabadi
Street address
Emam Khomeini Hospital, Orthopedic Department, Joint Reconstruction Research Center, Chamran Highway, Baqerkhan East Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1653
Email
dr.mohammad.ayati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fatuhi
Street address
Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Behzad Nezhad Tabrizi
Position
orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Joint Reconstruction Research Center, Orthopedic Department, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
009892166581653
Email
tabrizibehzad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ayati Firozabadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Joint Reconstruction Research Center, Orthopedic Department, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1653
Email
dr.mohammad.ayati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behzad Nezhad Tabrizi
Position
orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Joint Reconstruction Research Center, Orthopedic Department, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1653
Email
tabrizibehzad@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
Access to the raw data of the study will be given
When the data will become available and for how long
9 months after the completion of the project
To whom data/document is available
Researchers associated with academic centers
Under which criteria data/document could be used
n case of sending an official request to the project manager
From where data/document is obtainable
Mohammad Ayati Firozabadi
dr.mohammad.ayati@gmail.com
Orthopedic Department, Joint Reconstruction Research Center
What processes are involved for a request to access data/document
Sending official emails from related academic centers