Evaluation and comparison of the effect of preoperative use of celecoxib , gabapentin , combination of celecoxib with gabapantin and combination of celecoxib with dexamethasone and gabapantin in reducing postoperative pain in patients undergoing total knee replacement surgery
Evaluation and comparison of the effect of preoperative use of celecoxib alone, gabapentin alone, combination of celecoxib with gabapantin and combination of celecoxib with dexamethasone and gabapantin in reducing postoperative pain in patients undergoing total knee arthroplasty
Design
Clinical trial without control group with parallel, randomized, phase 3 groups on 144 patients
Settings and conduct
This study is performed in Kashani Hospital in Isfahan. Before surgery, patients receive different painkillers depending on their group. The patients will then undergo surgery and their pain will be assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years, first candidate for knee replacement surgery, Candidate for unilateral TKA surgery due to primary osteoarthritis, consent to participate in the study. Exclusion criteria: Lack of follow-up and examination of the patient's condition, patient death, chronic diseases
Intervention groups
Intervention group 1: Patients in this group are treated with two doses of 400 mg celecoxib alone before surgery.
Intervention group 2: Patients in this group are treated with two doses of 300 mg gabapentin alone before surgery.
Intervention group 3: In this group, patients in addition to 400 mg celecoxib, are treated with two doses of 300 mg gabapentin before surgery.
Intervention group 4: Patients in this group will receive two doses of dexamethasone 4 mg in addition to celecoxib 400 mg and gabapentin 300 mg.
The pain of all patients will be assessed by visual analog criteria at 24, 48 and 72 hours after surgery.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N10
Registration date:2021-02-04, 1399/11/16
Registration timing:prospective
Last update:2021-02-04, 1399/11/16
Update count:0
Registration date
2021-02-04, 1399/11/16
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-18, 1399/11/30
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effect of preoperative use of celecoxib , gabapentin , combination of celecoxib with gabapantin and combination of celecoxib with dexamethasone and gabapantin in reducing postoperative pain in patients undergoing total knee replacement surgery
Public title
The effect of preoperative use of celecoxib , gabapentin , combination of celecoxib with gabapantin and combination of celecoxib with dexamethasone and gabapantin on postoperative pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Candidate for unilateral TKA surgery due to primary osteoarthritis
Satisfaction to participate in the study
Exclusion criteria:
Failure to follow up and examine the patient's condition
Death of the patient
Having chronic diseases
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of IsfahanUniversity of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.MUI.MED.REC.1399.948
Health conditions studied
1
Description of health condition studied
Total Knee Arthroplasty
ICD-10 code
D86.86
ICD-10 code description
Sarcoid arthropathy
Primary outcomes
1
Description
Pain
Timepoint
24, 48 and 72 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group are treated with two doses of 400 mg celecoxib alone before surgery and their pain will be assessed by analog visual criteria at 24, 48 and 72 hours after surgery.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in this group are treated with two doses of 300 mg of gabapentin alone before surgery and their pain will be assessed by visual analog criteria at 24, 48 and 72 hours after surgery.
Category
Treatment - Drugs
3
Description
Intervention group 3: Patients in this group, in addition to 400 mg celecoxib, are treated with two doses of 300 mg gabapentin before surgery and their pain will be assessed by visual analog criteria at 24, 48 and 72 hours after surgery.
Category
Treatment - Drugs
4
Description
Intervention group 4: Patients in this group, in addition to celecoxib 400 mg and gabapentin 300 mg, will also receive two doses of dexamethasone 4 mg before surgery and their pain will be assessed by visual analog criteria at 24, 48 and 72 hours after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Mehdi Motififard
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
motififard@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Web page address
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
Mehdi Motififard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
motififard@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Motififard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
motififard@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Motififard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
motififard@med.mui.ac.ir
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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.