The purpose of this clinical trial is to compare analgesia due to nitroglycerin and meperidine added to lidocaine to lidocaine and meperidine in the IV regional anesthesia. A total of 50 patients aged 18-60 years old who are candidates for hand and wrist surgery are randomly assigned into one of the intervention groups. After BP and HR measurement and sedating by 1microg/kg IV fentanyl and 1.5 mg Midazolam double cough tornique is fastened around the arm. Blood of the organ is discharged by smarch band and proximal cough is inflated.150mmHg more than systolic Blood Pressure then the smarch band is unfastened. 200mg lidocaine & 50 mg Meperidine (totally40cc) is infused during 90 seconds in the case group & 200mg lidocaine , 50mg meperidine & 200 microg Nitroglycerin is infused in the control group . After feeling pain, Proximal tornique is difelated and distal tornique is inflated. 150mmHg more than systolic BP. BP & HR & VAS (Visual analog scaling) (Painless 0-Very painful 10) is checked 1, 5,10,20,30 mins after tornique inflation & 1,5,10 mins & 2 hours after tornique defilation. During the surgery 1-3microg/kg fentanyl is injected if there was a pain & if the pain was not controlled General Anesthesia is considered. The patient is asked about the surgical pain and the pain caused by Tornique and the end of the surgery. The quality of painlessness is divided in 3 groups: excellent (Painless), Good (Little pain & no need to infuse fentanyl), intermediate (sever pain which relieves by fentanyl),Bad ( Patient who doesn’t tolerate IV Local Anesthesia ). The period of time from operating the tornique until 2 hours after asking for an analgesic is considered as the onset of the pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012254923N2
Registration date:2011-11-07, 1390/08/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-07, 1390/08/16
Registrant information
Name
Bahman Hasannasab
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
bahmanh2002@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of Research, Babol University of Medical Sciences
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesia due to nitroglycerine & meperidine added to lidocaine to lidocaine and meperidine in the IV regional anesthesia
Public title
Comparison of analgesia due to nitroglycerine & meperidine added to lidocaine to lidocaine and meperidine in the IV regional anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-60 year old, candidate for hand and wrist surgery
Exclusion criteria: history of hypertension, Diabetes, Convulsion, Sensitivity to general anesthetics, Dependency on narcotics
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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Daneshgah Sq., Ganjafrooz St., Babol
City
Babol
Postal code
Approval date
2009-07-07, 1388/04/16
Ethics committee reference number
3861/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Injuries to the wrist and hand
ICD-10 code
S60, S61,
ICD-10 code description
Superficial injury of wrist and hand
2
Description of health condition studied
local anaesthetics
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
analgesia
Timepoint
1, 5, 10, 20, 30 mints after tornique inflation & 1, 5, 10 mints & 2 hours after unfastening the tornique
Method of measurement
Visual Analogue Scale - Visual -questionnaire
Secondary outcomes
1
Description
Blood Pressure
Timepoint
1, 5, 10, 20, 30 mints after tornique inflation & 1, 5, 10 mints & 2 hours after unfastening the tornique
Method of measurement
BP Cuff
2
Description
Heart Rate
Timepoint
1, 5, 10, 20, 30 mints after tornique inflation & 1, 5, 10 mints & 2 hours after unfastening the tornique
Method of measurement
Pulse Oximeter - ECG
Intervention groups
1
Description
Intervention group: 200mg Lidocaine, 50mg Meperidine & 200 microgram TNG (Totally 40 cc) is injected IV in Hand
Category
Treatment - Drugs
2
Description
Control group: 200mg Lidocaine, 50mg Meperidine (Totally 40 cc) is injected IV in Hand
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Bahman Hasannasab
Street address
Sargurd Ghasemi St -Babol
City
Babol
2
Recruitment center
Name of recruitment center
Shahid Yahyanejad Hospital
Full name of responsible person
Dr Bahman Hasannasab
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Bahman Hasannasab
Street address
Anesthesiology Department -Ayatollah Ruhani Hospital
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University Of Medical Sciences
Full name of responsible person
Dr Bahman Hasannasab
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department -Ayatollah ruhani Hospital
City
Babol
Postal code
Phone
+98 111223896
Fax
Email
bahmanh2002@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)