Determining and comparing the effects of oral meloxicam and diclofenac on pain control after knee replacement surgery
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 128 patients. "Random allocation" computer software will be used for randomization.
Settings and conduct
64 patients referred to Imam Khomeini Hospital (RA) in Urmia who are candidates for knee joint replacement surgery will be included in the study.
Participants/Inclusion and exclusion criteria
In this double-blind clinical trial study, 64 patients referred to Imam Khomeini Hospital (RA) in Urmia who are candidates for knee joint replacement surgery will be included in the study.
Inclusion criteria:
1. Diagnosis of knee osteoarthritis based on the scales of the American Society of Anesthesiology (9)
2. candidate for knee joint replacement surgery
3. American Society of Anesthesiology grade 1 and 2 patients
4. No history of corticosteroid or hyaluronic acid injection into the joint during the past three months
5. No history of knee surgery or interventional treatment
Exit criteria:
1. Age less than 18 years
2. consumption of painkillers during the last 7 days
3. Blood and coagulation disorders
4. severe heart failure, liver and kidney
5. Any absolute and relative contraindications to the use of drugs during the study
6. Nervous disorders and the impossibility of accurately understanding the sensation of pain
7. Pregnancy and breastfeeding
8. Patients using the intravenous form of morphine
Intervention groups
Patients will be divided into two groups in a simple random manner using the numbers given by "Random Allocation" computer software.
In the meloxicam group, 15 mg of oral meloxicam and in the diclofenac group 100 mg of oral diclofenac will be given at 4, 24 and 48 hours after surgery.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056613N4
Registration date:2023-07-11, 1402/04/20
Registration timing:registered_while_recruiting
Last update:2023-07-11, 1402/04/20
Update count:0
Registration date
2023-07-11, 1402/04/20
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
2023-05-21, 1402/02/31
Expected recruitment end date
2024-03-17, 1402/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of oral Meloxicam and Diclofenac after knee arthroplasty
Public title
Comparison of the analgesic effect of oral Meloxicam and Diclofenac after knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of knee osteoarthritis based on the scales of the American Society of Anesthesiology
Candidate for knee joint replacement surgery
American Society of Anesthesiology grade 1 and 2 physical status patients
No history of corticosteroid or hyaluronic acid injections into the joint during the past three months
No history of knee surgery or interventional treatment
Exclusion criteria:
Age less than 18 years
pain reliever use in the past 7 days
Blood and coagulation disorders
Severe heart-liver and kidney failure
Any absolute and relative contraindications to the use of drugs during the study
Nervous disorders and the inability to accurately perceive the sensation of pain
Pregnancy and breastfeeding
Patients using the intravenous form of morphine
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
128
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 25 codes will be in the case group and the second 25 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 in research of Imam Khomeini Medical Education Center of Urmia University of Medic
Street address
Imam Khomeini Hospital, Ershad Street
City
Urmia
Province
West Azarbaijan
Postal code
2245898115
Approval date
2022-08-08, 1401/05/17
Ethics committee reference number
IR.UMSU.HIMAM.REC.1401.091
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified
Primary outcomes
1
Description
Intensity of pain
Timepoint
Pain intensity will be measured at 24, 48 and 72 hours after the operation.
Method of measurement
The intensity of pain after the operation of the patients will be measured using a visual analog index and scoring method from 0 (no pain) to 10 (unbearable pain).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In the intervention group, the oral form of 15 mg meloxicam will be administered.
Category
Treatment - Drugs
2
Description
Control group: In the control group, the same method will be used, but with the use of 100 mg diclofenac.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Urmia
Full name of responsible person
Reza Ghaderi
Street address
Imam Khomeini Hospital, Ershad Street
City
Urmia
Province
West Azarbaijan
Postal code
25486551237
Phone
+98 933 395 5273
Email
rezaqaderi20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Ghaderi
Street address
Imam Khomeini Hospital, Ershad Street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 933 395 5273
Email
rezaqaderi20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Urmia University of Medical Sciences
Proportion provided by this source
10
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
Ali Akbar Nasir
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam khomini university hospital, Eeshad AVE, Modarres Blvd, urmia, iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 7286
Email
Nasiriali7@gmail.com
Web page address
https://umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ali Akbar Nasir
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Khomini university hospital, Eeshad AVE, Modarres Blvd, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 7286
Email
Nasiriali7@gmail.com
Web page address
https://umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ali Akbar Nasir
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Khomini university hospital, Eeshad AVE, Modarres Blvd, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 7286
Email
Nasiriali7@gmail.com
Web page address
https://umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
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
No - There is not a plan to make this available
Title and more details about the data/document
All data is shareable
When the data will become available and for how long
1 year after the results are published
To whom data/document is available
It will be available only for researchers working in academic and scientific institutions b
Under which criteria data/document could be used
After analyzing the data.
From where data/document is obtainable
Imam Khomeini Hospital Urmia
What processes are involved for a request to access data/document
Refer to the Research Department of Imam Khomeini Hospital in Urmia