measuring The effect of tranexamic acid injection during anterior cruciate ligament reconstruction surgery on postoperative bleeding, pain and swelling
Determining the effect of transamine acid injection during anterior cruciate ligament reconstruction surgery on postoperative bleeding, pain and swelling after surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 60 patients.
Settings and conduct
Patients who have referred to Al-Zahra and Kashani hospitals in Isfahan city for anterior cruciate ligament repair surgery are placed in two random groups and one group is injected with tranexamic acid and the other group with normal saline during surgery.
The range of motion of the knee joint, the amount of pain, swelling, and degree of hemarthrosis are evaluated before surgery.
After surgery, the drain output is measured in the first 24 hours.
Also, the amount of pain, swelling and degree of hemarthrosis in the first 24 hours, the third day and one month after surgery and the range of motion and functional score of the knee one month after surgery are evaluated.
Pain is measured using the Visual Analogue Scale (VAS).
Patients and the person receiving postoperative care are unaware of the drug injection or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Anterior cruciate ligament rupture
Exclusion criteria:
Having any type of coagulation disorder; Rheumatic disease; Previous surgical history; Severe swelling of the joint before surgery
Intervention groups
The first study group receiving 15 mg / kg tranxamic acid per 100 cc of normal saline before opening the tourniquet. In the second group, only normal saline is injected in the same volume from the first group.
Main outcome variables
Joint pain; range of motion of the joint; Inflation; Hemarthrosis; Drain output; Knee functional score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201015049033N1
Registration date:2021-05-12, 1400/02/22
Registration timing:prospective
Last update:2021-05-12, 1400/02/22
Update count:0
Registration date
2021-05-12, 1400/02/22
Registrant information
Name
reza entezari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 4247
Email address
drreza.ent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
measuring The effect of tranexamic acid injection during anterior cruciate ligament reconstruction surgery on postoperative bleeding, pain and swelling
Public title
measuring The effect of tranexamic acid injection during anterior cruciate ligament reconstruction surgery
Having coagulation diseases
Rheumatic diseases of the joints
History of previous knee joint surgery
Receive anticoagulant therapy before surgery
Coagulation profile disorder before surgery
Cycle cell anemia
Sensitivity to tranexamic acid
Severe swelling of the joint before surgery
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple and individual randomization method is done through a random numbers table and The group of patients is given to the operating room nurse to prepare the medicine or placebo for injection.
First we defined the framework of our statistical community and randomly started from a point in the table in the direction of the row or column. Depending on the type of code, we selected the same number of digits in the row or column direction. We continued this work until the number of samples was completed. even numbers were used for the intervention group and individual numbers for the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients has no knowledge of injecting medication or placebo during surgery.A person who monitors the amount of drainage, the degree of hemarthrosis, the range of motion of the knee joint, and the amount of pain and swelling has no knowledge of injecting medication or placebo during surgery.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
shohada sofe Ave., Al-zahra hospital
City
Isfahan
Province
Isfehan
Postal code
8173815796
Approval date
2021-02-07, 1399/11/19
Ethics committee reference number
IR.MUI.MED.REC.1399.1028
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament rupture
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
joint pain
Timepoint
Before surgery, the first 24 hours after surgery and on the third day and the first month after surgery
Method of measurement
Visual analogue scale (VAS)
2
Description
Range of motion of the knee joint
Timepoint
Before surgery and one month after surgery
Method of measurement
angle
3
Description
Hemarthrosis
Timepoint
Before surgery, the first 24 hours after surgery and on the third day and the first month after surgery
Method of measurement
check list
4
Description
Drain output
Timepoint
The first 24 hours after surgery
Method of measurement
volume in cc
5
Description
Knee functional score
Timepoint
one month after surgery
Method of measurement
score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:During anterior cruciate ligament repair surgery, 15 mg / kg tranexamic acid into 100 cc of normal saline is injected before opening the tourniquet.
Category
Rehabilitation
2
Description
Control group: During anterior cruciate ligament surgery in the control group with the same volume as the intervention group, normal saline is injected before opening the tourniquet.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital of Isfahan
Full name of responsible person
Reza Entezari
Street address
Shohada Sofe Ave.
City
Isfahan
Province
Isfehan
Postal code
8173815796
Phone
+98 31 3620 2020
Email
drreza.ent@gmail.com
2
Recruitment center
Name of recruitment center
Kashani Hospital of Isfahan
Full name of responsible person
Reza Entezari
Street address
Kashani Ave.
City
Isfahan
Province
Isfehan
Postal code
8173815796
Phone
+98 31 3233 0091
Email
drreza.ent@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saghayegh Haghjoo Javanmard
Street address
Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8173815796
Phone
+98 31 3620 2020
Email
drreza.ent@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Reza Entezari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shohada Sofe Ave.
City
Isfahan
Province
Isfehan
Postal code
8173815796
Phone
+98 31 3620 2020
Email
drreza.ent@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Mousavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Kashani Ave.
City
Isfahan
Province
Isfehan
Postal code
8173815796
Phone
+98 31 3620 2020
Email
h_mousavi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Entezari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shohada Sofe Ave.
City
Isfahan
Province
Isfehan
Postal code
8173815796
Phone
+98 31 3620 2020
Email
drreza.ent@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Patient information including patient age and preoperative findings and postoperative outcomes that are relevant to the study and the type of drug injected into the patient can be disseminated.
When the data will become available and for how long
Six months after the results were published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Data are provided for similar studies and other statistical analyzes.
From where data/document is obtainable
To receive information, send an email to the following address:
drreza.ent@gmail.com
What processes are involved for a request to access data/document
About two months after the email is sent and the data is verified.