To assess the effect of memantine versus placebo on pain in patients undergoing knee joint surgery
Design
This is a Phase III double-blind randomized clinical trial with a control group, in which eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct
This study will be conducted at the Rasool Akram Hospital in Tehran city, involving 42 eligible patients undergoing knee joint surgery. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Candidate for knee joint surgery
Physical health class 1 or 2
Exclusion criteria:
Chronic heart disease
Psychiatric diseases
Alzheimer's disease
Drug or alcohol addiction
Intervention groups
Intervention group:
Routine treatment plus memantine tablets 20 mg daily three days before surgery and then 10 mg daily after surgery for 2 weeks
Control group:
Routine treatment plus a placebo pill daily three days before surgery and then a placebo pill daily after surgery for 2 weeks
Main outcome variables
Primary outcome:
Pain score, pain quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N491
Registration date:2023-12-02, 1402/09/11
Registration timing:prospective
Last update:2023-12-02, 1402/09/11
Update count:0
Registration date
2023-12-02, 1402/09/11
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of memantine versus placebo on pain in patients undergoing knee joint surgery: a double-blind randomized clinical trial
Public title
Effect of memantine versus placebo on pain in patients undergoing knee joint surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Candidate for knee joint surgery
Physical health class 1 or 2
Exclusion criteria:
Chronic heart disease
Psychiatric diseases
Alzheimer's disease
Drug or alcohol addiction
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a double-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Medicine – Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, beside Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-02-22, 1401/12/03
Ethics committee reference number
IR.IUMS.REC.1401.996
Health conditions studied
1
Description of health condition studied
knee joint disorders
ICD-10 code
M25.86
ICD-10 code description
Other specified joint disorders, knee
Primary outcomes
1
Description
Pain score
Timepoint
On the first, second, third, fourth, fifth and fourteenth days after surgery
Method of measurement
Using Visual Analog Scale (VAS)
2
Description
Pain quality
Timepoint
On the first, second, third, fourth, fifth and fourteenth days after surgery
Method of measurement
Using the McGill questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus memantine tablets 20 mg daily three days before surgery and then 10 mg daily after surgery for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: Routine treatment plus a placebo pill daily three days before surgery and then a placebo pill daily after surgery for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital in Tehran city
Full name of responsible person
Dr. Azadeh Eshraghi
Street address
Rasool Akram Hospital, Sattar khan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
aepharm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abbas Motevalian
Street address
Iran University of Medical Sciences, beside Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Azadeh Eshraghi
Position
Clinical Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
International Campus, Iran University of Medical Sciences, beside Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
aepharm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Azadeh Eshraghi
Position
Clinical Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
International Campus, Iran University of Medical Sciences, beside Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
aepharm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available