Comparison of analgesic effect of intra articular ((bupivacaine)) with ((magnesium sulphate and bupivacaine )) following knee arthroscopy under spinal anesthesia.
This research is conducted for comparison of analgesic effect of intra articular ((bupivacaine)) with ((magnesium sulphate and bupivacaine )) following knee arthroscopy under spinal anesthesia. Inclusion criteria are: patients who are candidate for arthroscopic knee surgery having ASA class 1, 2 and their age range between 18 to 60 years. Exclusion criteria are: patients with contraindication for spinal anesthesia or refuse spinal anesthesia; patient with chronic pain or allergy to local anesthetics and patients with history of chronic analgesic use (nonsteroidal anti-inflammatory drugs, opioids, or paracetamol). Forty five patients undergoing arthroscopic knee surgery under spinal anesthesia with 2 ml bupivacaine 0.5% were randomized blindly into one of three parallel groups. The saline placebo group (group A) received 10 mL of isotonic saline, The bupivacaine group (group B) received 0.20% (10 mL) bupivacaine, whereas the magnesium with bupivacaine group (group MB) receive bupivacaine 0.20% and 1 g of magnesium sulfate in 10 mL at the end of surgery and before release of the tourniquet. The postoperative pain will be assessed using NRS recorded after surgery at 4, 6, 8, 12, and 24 hours. Patients will be evaluated at rest.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106026687N1
Registration date:2011-09-21, 1390/06/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-21, 1390/06/30
Registrant information
Name
Reza Alizadehkashani
Name of organization / entity
Ahwaz Jondishapoor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 7709
Email address
alizadeh.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapoor University of Medical Sciences
Expected recruitment start date
2010-11-28, 1389/09/07
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of intra articular ((bupivacaine)) with ((magnesium sulphate and bupivacaine )) following knee arthroscopy under spinal anesthesia.
Public title
Comparison of analgesic effect of intra articular ((bupivacaine)) with ((magnesium sulphate and bupivacaine )) following knee arthroscopy under spinal anesthesia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients' age between 18 to 60 years and patients having ASA class 1 or 2
Exclusion criteria: having contraindication for spinal anesthesia or refuse spinal anesthesia; patients with chronic pain or allergy to local anesthetics and patients with history of chronic analgesic use (nonsteroidal anti-inflammatory drugs, opioids, or paracetamol)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
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 Jondishapoor University of Medical Sciences
Street address
Shaher daneshgah
City
Ahwaz
Postal code
6135715794
Approval date
2010-11-27, 1389/09/06
Ethics committee reference number
eth019
Health conditions studied
1
Description of health condition studied
Pain relief after knee arthroscopy surgery
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Pain
Timepoint
4, 6, 8, 12 and 24 hours after
Method of measurement
Numeric rating scale
Secondary outcomes
1
Description
Pethedine consumpsion
Timepoint
4, 6, 8, 12 and 24 hours post operation
Method of measurement
Medical records
Intervention groups
1
Description
The first intervention group receives 0.20% (10 mL) bupivacaine intra articularly
Category
Prevention
2
Description
The seccond intervention group receives bupivacaine 0.20% and 1 g of magnesium sulfate in 10 ml salin solution intra articualrly
Category
Prevention
3
Description
The third intervention group receives 10 mL of isotonic saline intra articularly
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital, Ahvaz Jondishapoor University of Medical Sciences
Full name of responsible person
Dr.Mohamad Reza Pipelzadeh
Street address
Ahwaz, Imam Khomeini hospital
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jondishapoor University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhy
Street address
University city
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jondishapoor 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 Jondishapoor University of Medical Sciences
Full name of responsible person
Dr. Mohamad Reza Pipelzadeh
Position
Lecturer
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1222 5763
Email
dr_rpipel@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapoor University of Medical Sciences
Full name of responsible person
Dr. Mohamad Reza Pipelzadeh
Position
Lecturer
Other areas of specialty/work
Street address
Imam khomeini hospital, ICU
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1222 2114
Email
dr_rpipel@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapoor University of Medical Sciences
Full name of responsible person
Reza Alizadeh Kashani
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Imam Khomeini hospital
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1222 2114
Email
dralizadeh.reza@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)