The aim of this study is to evaluate the effect of pre-operative oral memantine on pain following orthopedic surgery in Zahedan in 2015 and 2016. This study is a double blind randomized clinical trial. 11 blocks (10 patients for each block) was used for randomization with an equal number of cards for each case and control groups based on factorial design. Both patients and the researchers who collected questionnaires from patients were not aware of the intervention type. Inclusion criteria included patients who require orthopedic surgery of the lower limbs below the knee, and exclusion criteria including dissatisfaction of patients and complications occurring in patients. In this study, 110 patients (55 patients in the intervention group and 55 patients in the control group) will be enrolled. In intervention group 20 mg of memantine was administrated and placebo was administrated to the other group one hour before surgery. Then pain severity (based on the Visual Analogue Scale) and analgesic amount was evaluated in 30 and 60 minutes, 2, 12 and 24 hours after surgery in two groups of patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101824576N1
Registration date:2016-06-10, 1395/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-10, 1395/03/21
Registrant information
Name
Khalil Soloki
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5725
Email address
solokikhalil@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of pre-operative oral memantine and placebo on pain following orthopedic surgery
Public title
Oral memantine and pain after orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria including age range between 18 and 60 years, having indications for spinal anesthesia, having surgery of the lower limbs below the knee for bone plaque embedding. Exclusion criteria including any postoperative complication requires surgical intervention, lack of consent to participate in the study, having a history of substance abuse, history of chronic disease such as diabetes, high blood pressure and etc. taking medication, having a mental illness, having known hypersensitivity to the ketamine drug, having mental retardation and loss of consciousness, hemodynamic disorders, bleeding disorders and anemia
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
School of Medicine - Zahedan University of Medical Sciences - Janet Boulevard – Dr. Hesabi Square - Zahedan
City
Zahedan
Postal code
43181-98167
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
2484
Health conditions studied
1
Description of health condition studied
Patients needing orthopedic surgery of the lower limbs below the knee
ICD-10 code
S80-S99
ICD-10 code description
Injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
Pain intensity
Timepoint
30 and 60 minutes, 2, 12 and 24 hours after surgery
Method of measurement
VAS (Visual Analogue Scale) ruler
Secondary outcomes
1
Description
consumption of Analgesic amount
Timepoint
30 and 60 minutes, 2, 12 and 24 hours after surgery
Method of measurement
mg
Intervention groups
1
Description
Intervention 1: In the intervention group 20 mg of memantine were administrated one hour before surgery for the patient.
Category
Treatment - Drugs
2
Description
Intervention 2: In the control group placebo were administrated (a capsule containing starch inside the shed) one hour before surgery for the patient.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Khatamolanbia hospital
Full name of responsible person
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Zahedan University of Medical Sciences
Full name of responsible person
Houshang Rafighdost
Street address
School of Medicine - Zahedan University of Medical Sciences – Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Khalil Souloki
Position
resident
Other areas of specialty/work
Street address
School of Medicine - Zahedan University of Medical Sciences - Janet Boulevard – Dr. Hesabi Square – Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5796
Fax
Email
solokikhalil@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Mohamad Nasialdin Tabatabaei
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Medicine - Zahedan University of Medical Sciences - Janet Boulevard – Dr. Hesabi Square – Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5796
Fax
Email
Ar_dashipoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
khalil souloki
Position
resident
Other areas of specialty/work
Street address
School of Medicine - Zahedan University of Medical Sciences - Janet Boulevard – Dr. Hesabi Square – Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5796
Fax
Email
solokikhalil@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)