Protocol summary

Summary
This randomized controlled,double blind study will done after approval by ethical committee of Ahvaz Jundishapoor University of Medical Sciences and taking the clinical randomized trial code from the IRCTcenter.52patients candidate for elective surgeries of upper limb addmitted in trauma center of Imamkhomeini hospital in Ahvaz will been studied.after obtaining the written informed consent from patients,they wil randomly allocated into 2 groups A&B.under standard monitoring and IV access patients will receive oxygen with face mask ,fluid and premedication with sedative drugs.the supraclavicular brachial plexus block will performed using ultrasonographic gauide with anesthesiologist.groupe A will receive solution of Lidocain plus magnesium sulfate and groupe B will receive Lidocain plus normal salin.the anesthesiology resident who didnot know about the pharmaceutical composition and patient groups,will assess the sensory and motor block,vital signs and postoperative pain,and will complete the questionnaire. sensory block level will assess by pinprick testing dermatomes of sensory regions with using 3-point scale.the intensity of motor block will assess using the modified bromage scale.during surgery ECG,HR,NIBPand oxygen saturation will monitored and written every 15 minutes.postoperative pain wil assess using VAS score at 0,1,2,4,8,16&24 hours after surgeries.patients with VAS>3 will receive analgesic as meperidin 25 mg/IM.the side effects will assess during surgeries and 24 hours afterthem.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016051727954N1
Registration date: 2016-06-19, 1395/03/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-06-19, 1395/03/30
Registrant information
Name
Mohsen Davarimoghadam
Name of organization / entity
Ahvaz Jundishapoor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 0168
Email address
davarimoghadam.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapoor University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium sulfate on postoperative pain in upper limb surgeries by supraclavicular block under ultrasonic gauide.
Public title
The effect of magnesium sulfate on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:ASAclass1&2 exclusion:patient reffuse,hypersensitivity to drugs used in study,coagulation abnormality,infection in the site of injection,traumatic nerve injury and need for general anesthesia
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
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 Ahvaz Jundishapoor University of Medical Sciences
Street address
Golestan
City
Ahvaz
Postal code
6135715794
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.AJUMS.REC.1395.61

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
18
ICD-10 code description
Acute pain

Primary outcomes

1

Description
Post Operation Pain
Timepoint
0,1,2,4,8,16,24 hour
Method of measurement
Visual Analoge Scale

Secondary outcomes

1

Description
Sensory block
Timepoint
1minute
Method of measurement
Pinprick

2

Description
Motor block
Timepoint
2minute
Method of measurement
Modified Bromage Scale

Intervention groups

1

Description
intervention group:lidocain1% 35ml+magnesium sulfate1gr as 5ml
Category
Treatment - Drugs

2

Description
control goup: lidocain1%35ml+salin normal 5ml
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohsen Davarimoghadam
Street address
Golestan
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapoor University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmalzade
Street address
Golestan
City
Ahvaz
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 Ahvaz Jundishapoor 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 Jundishapoor University of Medical Sciences
Full name of responsible person
Mohsen Davarimoghadam
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Golestan
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3222 0168
Fax
+98 61 3222 0168
Email
Davarimoghadam.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapoor University of Medical Sciences
Full name of responsible person
Reza Akhondzade
Position
Anesthesiology Specialist
Other areas of specialty/work
Street address
Golestan
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3222 0168
Fax
+98 61 3222 0168
Email
Rezaakh@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapoor University of Medical Sciences
Full name of responsible person
Mohsen Davarimoghadam
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Golestan
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3222 0168
Fax
+98 61 3222 0168
Email
Davarimoghadam.m@ajums.ac.ir
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
Loading...