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The effect of intraarticular magnesium sulfate on postoperative pain after knee arteroscopy

Protocol summary

Summary
The purpose of this study is to evaluate the effects of intraarticular administration of magnesium sulphate on postoperative pain in the patients who are candidate for knee artheroscopy for repair of anterior cruciate ligament . In this randomized double blind trial, 60 patients, aged 18-55 years old, and ASA physical status I and II, are assigned into two groups(30 patients in every group ).Induction of anesthesia and route of surgery are the same for all the patients.The patients receive randomly intraarticular administration of 1g of magnesium sulphate in 10 ml normal saline at the end of the surgery or placebo(10 ml normal saline). Pain is assessed through visual analog scale (VAS) at1, 2, 6, 12, 18 and 24 hours after the surgery. In addition, the first request of the patient for analgesia, the amount of opioid consumed, and side effects of magnesium sulphate (flashing ,hypotension, bradycardia) are evaluated during 24 hours and compared between the groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204092963N8
Registration date: 2012-04-21, 1391/02/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-04-21, 1391/02/02
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2012-03-10, 1390/12/20
Expected recruitment end date
2012-09-10, 1391/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intraarticular magnesium sulfate on postoperative pain after knee arteroscopy
Public title
The effect of intraarticular magnesium sulfate on postoperative pain after knee surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients with American Society of Anesthesia (ASA) physical status I or II who are candidate for elective ACL artheroscopy, age18-55years old Exclusion criteria: patients with mental impairment,chronic pain ,a history of addiction were excluded.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2012-03-07, 1390/12/17
Ethics committee reference number
159135

Health conditions studied

1

Description of health condition studied
pain in knee
ICD-10 code
M79.6
ICD-10 code description
Pain in limb

Primary outcomes

1

Description
postoperative pain
Timepoint
1, 2, 6, 12, 18 and 24 hours after the surgery
Method of measurement
visual analog scale (VAS)

Secondary outcomes

1

Description
opioid consumption
Timepoint
during 24 hours after operation
Method of measurement
mg morphine

2

Description
the first request of the patient for analgesic
Timepoint
during 24 hours after operation
Method of measurement
in hours

3

Description
Drug side effects
Timepoint
during 24 hours after the operation
Method of measurement
asking the patient

Intervention groups

1

Description
intraarticular administration of 1g of magnesium sulphate in 10 ml normal saline at the end of the surgery
Category
Treatment - Drugs

2

Description
intraarticular administration of placebo(10 ml normal saline) at the end of the surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr.Shekoufeh Behdad
Street address
Shahid Sadoughi Hospital
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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