Protocol summary
-
Study aim
-
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 100 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)
100 mg of lidocaine (5 cc)
23.5cc of normal saline solution
Control group:
30mg Ketorolac ampoule(1cc)
5mg morphine sulfate(0.5cc)
100 mg of lidocaine (5 cc)
33.5cc 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
-
updating some of protocol fields
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20221230056983N1
Registration date:
2023-02-25, 1401/12/06
Registration timing:
registered_while_recruiting
Last update:
2025-01-30, 1403/11/11
Update count:
1
-
Registration date
-
2023-02-25, 1401/12/06
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2022-04-01, 1401/01/12
-
Expected recruitment end date
-
2023-10-31, 1402/08/09
-
Actual recruitment start date
-
2022-04-01, 1401/01/12
-
Actual recruitment end date
-
2023-10-31, 1402/08/09
-
Trial completion date
-
2024-01-29, 1402/11/09
-
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:
an isolated, unilateral, chronic ACL tear
Ability to read and write to give informed written consent and cooperate in the study
Use of hamstring autograft
American Society of Anesthesiologists (ASA) physical status of I
Exclusion criteria:
Drug sensitivity
multi-ligament injuries
bilateral ACL tears
acute ACL tears
bony deformities
a history of hematologic conditions or ischemic attacks
patients receiving anticoagulant therapy
-
Age
-
From 15 years old to 60 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
100
Actual sample size reached:
100
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Table of random numbers (four block) by site randomization.com
-
Blinding (investigator's opinion)
-
Triple 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
-
Ethics committees
1
-
Ethics committee
-
-
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, 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 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
1
-
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
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),100 mg of lidocaine (5 cc), 33.5 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)100 mg of lidocaine (5 cc) 23.5 cc normal saline solution; All made by Iranian pharmaceutical companies
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
ask for IPD through corresponding investigator
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available