This study aims to investigate the analgesic effect of magnesium sulfate during postoperative period in patients underwent knee arthroscopic partial meniscectomy. Inclusion criteria are male or female patients (18 to 45 years old) candidate of knee arthroscopic partial meniscectomy based on the MRI imaging. Exclusion criteria are elevated levels of serum magnesium (> 1mmol/l), known allergies to pharmaceutical agents using in the study, major dysfunction of liver and kidney and cardiovascular system, specific atrioventricular block, obesity and previous treatment with opoidal drugs, rheumatic diseases, ligamental damage of the knee and sever osteoarthritis of the knee. Ninty four patients are randomly divided into two groups (each 47 cases): one control group and one intervention groups. The intervention group receives 20 cc of normal saline containing 1 gr magnesium sulfate 10% after surgery and before opening the tourniquet by the surgeon and with using arthroscopy. The control group receives only 20 cc of normal saline. The primary outcome is assessment of pain based on the visual analogue score (VAS) after surgery in 5, 60, 120 and 240 min after entering the recovery room by researcher who is not aware of grouping.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012232117N1
Registration date:2017-04-15, 1396/01/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-15, 1396/01/26
Registrant information
Name
Babak Toloue Ghamari
Name of organization / entity
Ahvaz jundishapour university of medical siences
Country
Iran (Islamic Republic of)
Phone
+98 61 3372 6501
Email address
toloueghamari.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical ُsciences
Expected recruitment start date
2017-02-02, 1395/11/14
Expected recruitment end date
2017-05-02, 1396/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the analgesic effect of magnesium sulfate during postoperative period in patients underwent knee arthroscopic partial meniscectomy
Public title
Analgesic effect of magnesium sulfate in patients candidate of knee arthroscopic partial meniscectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are male or female patients (18 to 45 years old) candidate of knee arthroscopic partial meniscectomy based on the MRI imaging. Exclusion criteria are elevated levels of serum magnesium (> 1mmol/l), known allergies to pharmaceutical agents using in the study, major dysfunction of liver and kidney and cardiovascular system, specific atrioventricular block, obesity and previous treatment with opoidal drugs, rheumatic diseases, ligamental damage of the knee and sever osteoarthritis of the knee.
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
94
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blv., Research deputy, Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Postal code
61357-15794
Approval date
2017-01-07, 1395/10/18
Ethics committee reference number
IR.AJUMS.REC.1395.671
Health conditions studied
1
Description of health condition studied
Meniscal tears
ICD-10 code
M23.2
ICD-10 code description
Derangement of meniscus due to old tear or injury Old bucket-handle tear
Primary outcomes
1
Description
Pain score (VAS)
Timepoint
5, 60, 120, and 240 min after entering the recovery room
Method of measurement
Visual analogue score
Secondary outcomes
empty
Intervention groups
1
Description
Group intervention: patients receive 20 cc of normal saline containing 1 gr magnesium sulfate 10% in their knees
Category
Treatment - Drugs
2
Description
In control group: patients only receive 20 cc normal saline in their knees
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital, Ahvaz Jundishapur University of Medical Siences
Full name of responsible person
Dr Hanoon Sadoni
Street address
Amanieh, Razi Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical ُSciences
Full name of responsible person
Behzad Sharif Makhmalzadeh, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blv., Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
PAIN-9506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical ُSciences
Full name of responsible person
Babak Toloue Ghamari
Position
Orthopedic Assistant
Other areas of specialty/work
Street address
Amanieh, Razi Hospital
City
Ahvaz
Postal code
6196514941
Phone
+98 61 3333 6488
Fax
Email
babak.toloueghamari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical ُSciences
Full name of responsible person
Dr Hanoon Sadoni
Position
Orthopedic specialist, assistant professor
Other areas of specialty/work
Street address
Amanie; Razi Hospital
City
Ahvaz
Postal code
6196514941
Phone
+98 61 3333 6488
Fax
Email
Dr.sadoni@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical ُSciences
Full name of responsible person
Babak Toloue Ghamari
Position
Orthopedic Assistant
Other areas of specialty/work
Street address
Amanieh, Razi Hospital
City
Ahvaz
Postal code
6196514941
Phone
+98 61 3333 6488
Fax
Email
babak.toloueghamari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)