The purpose of this study is evaluation of analgesic effect of nitroglycerin additive to lidocaine in intravenous regional anesthesia in elbow surgery. Randomized, double-blind study with placebo control will performed on patients. 70 patients requiring elective surgery forearm over the age of 20 years and without a history of sickle cell anemia and nitroglycerin consumption and allergies will divided into 2 groups. For both groups, intravenous regional anesthesia will used. In the first group will used a combination of lidocaine and nitroglycerin, but in the second group will used a lidocaine and normal saline. Vital signs including heart rate, blood pressure and venous oxygen saturation will be recorded before and after tourniquet use. Tourniquet pain will be measured by VAS score and will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072712642N17
Registration date:2015-08-15, 1394/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-15, 1394/05/24
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Zahedan University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of analgesic effect of nitroglycerin additive to lidocaine in intravenous regional anesthesia in forearm surgery
Public title
Analgesic effect of nitroglycerin additive to lidocaine in intravenous regional anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: non urgent surgery; age more than 20 years.
Exclusion criteria: Sickle cell anemia; Raynaud's phenomena; history of use of nitroglycerine; history of use of sildenafil in 24 hours ago; history of allergy.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized using sealed envelopes will be done.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr Hesabi.Squ
City
Zahedan
Postal code
Approval date
2011-06-22, 1390/04/01
Ethics committee reference number
420/ت
Health conditions studied
1
Description of health condition studied
The intravenous regional anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Anaesthetics and therapeutic gases
Primary outcomes
1
Description
Patient's tourniquet pain
Timepoint
At 5, 10, 15, 20, 40 minutes after the start of operation will be evaluated.
Method of measurement
According to VAS score
2
Description
Venous oxygen saturation
Timepoint
Before and after use tourniquet
Method of measurement
By pulse oximetry based on mmHg
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Before and after use tourniquet
Method of measurement
By mercury sphygmomanometer based on mmHg
2
Description
Heart Rate
Timepoint
Before and after use Tourniquet
Method of measurement
By pulse oximetry based on the number of minutes
Intervention groups
1
Description
In the control group local anesthetic solution of 3miligeram per kilogeram body weight lidocaine with a concentration of 0.5percentage diluted with normal saline will injected via intravenous cannula on Back of the hand
Category
Prevention
2
Description
In the Intervention group local anesthetic of 3 miligeram per kilogeram body weight lidocaine with a concentration of 0.5percentage addition to 200 microgeram nitroglyserine injected via intravenous cannula on back of the hand.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatamol anbia Hospital
Full name of responsible person
Majid Golestani Eraghi
Street address
Jamejam Boulvar
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Zahedan University of Medical Sciences
Full name of responsible person
Hamidreza Mahmoodzadeh Sagheb
Street address
Dr Hesabi.Squ
City
Zahedan
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 Zahedan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Departman of Anesthesia of Shahid Beheshti University Of Medical Science
Full name of responsible person
Alireza Jahangirifard
Position
Fellowship of Cardiac Anesthesia
Other areas of specialty/work
Street address
Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
alirezajahangiri@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Departman of Anesthesia of Shahid Beheshti University Of Medical Science
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship specialty critical care
Other areas of specialty/work
Street address
Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)