Comparison of the Efficacy of Magnesium sulfate and Tramadol as an adjunct to the Intravenous Regional Block for Controlling Postoperative Pain Following Upper Extremity Surgeries.
The purpose of this study is to compare the effects of tramadol and magnesium sulfate in postoperative pain control after these surgeries. In this double-blind clinical trial of 69 patients ASA 1&2, which will be candidate for surgery of the hand and forearm,were randomly allocated into three groups of 23 patients. All patients will receive 3mg/kg lidocaine 0.5%, then for control group normal saline, group 1 magnesium sulfate and group 2 tramadol is will be injected. Demographic data will be recorded and postoperative pain which will be measured by visual analogue scale in the recovery room and ward every hour for 6 hours and then every 4 hours for 24 hours postoperatively will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040511662N6
Registration date:2014-05-23, 1393/03/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-23, 1393/03/02
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences .
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Magnesium sulfate and Tramadol as an adjunct to the Intravenous Regional Block for Controlling Postoperative Pain Following Upper Extremity Surgeries.
Public title
Comparison of the analgesic effect of magnesium and Tramadol after local anesthesia of upper extremity.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 69 patients 15-65 years old with ASA 1&2candidates for elective hand and forearm surgery or due to trauma.
Exclusion criteria: History of drug abuse; History of allergies to drugs such as local anesthetics or opioid; History of: liver diseases; cardiovascular disease; renal failure; sickle cell anemia; Raynaud's disease; coagulopathy; G6PD deficiency; seizures.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
69
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
Shiraz University Medical Research Ethic Committee
Street address
Shiraz University of Medical Sciences ,Zand Blv
City
Shiraz
Postal code
197871345
Approval date
2014-03-09, 1392/12/18
Ethics committee reference number
CT-P-92-6256
Health conditions studied
1
Description of health condition studied
Acute Postoperative Pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Postoperative pain intensity
Timepoint
Every hour for 6 hours and then every 4 hours for 24 hours after surgery
Method of measurement
Visual Anlouge Scale
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
Every one hour during first postoperative 24 hr
Method of measurement
Nausea is defined as urge to vomiting without ejection ofof the contents of the stomach through the mouth, Vomiting is defined asto eject of the contents of the stomach through the mouth, usually in a series of involuntary spasmic movements.
Intervention groups
1
Description
Control group: 10 cc saline in the 10 ml syringe will be injected into the patient by a resident of anesthesia who will not aware of the content of 10 cc syringe
Category
Treatment - Drugs
2
Description
Interventional group 1: 1.5 gram magnesium sulfate diluted with saline to a volume of 10 cc will be injected into the patient by a resident of anesthesia who will not aware of the content of 10 cc syringe .
Category
Treatment - Drugs
3
Description
Interventional group 2 : 100 miligram tramadol diluted with saline to a volume of 10 cc will be injected into the patient by a resident of anesthesia who will not aware of the content of 10 cc syringe .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Training and Medical Center operation room
Full name of responsible person
Mohammad Ali Sahmeddini
Street address
Chamran Training and Medical Center,Chamran Blv
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University Of Medical Sciences building,Zand Blv
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology
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
Shiraz University Of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq.
City
Shiraz
Postal code
7193711351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
MohammadAli Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddin@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)