In this double-blind randomized clinical trial, 60 ASA I and II patients, candidate for hand and Forearm surgeries ( tendon injuries ) aging from 18 to 50 years. The exclusion criteria were sickle cell anemia, hypersensitivity, G6PD, Raynaud's disease, drug abuse history and addiction, and open fracture.
The selected patients were randomly assigned ( with a simple random manner ) to receive either 200 microgram Nitroglycerin plus 3mg/kg lidocaine 2% diluted with saline to a total dose of 40 mL or only lidocaine 2% diluted with saline to a total dose of 40 mL ( each group 30 subjects ).
Sensory and motor block onset time, recovery time, need to fentanyl, Quality of Anesthesia Assessed by Patients and Surgeon, tourniquet time and vas were understudy variables. Data from 60 patients were analyzed using SPSS (version 18.0) software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105136465N1
Registration date:2011-06-11, 1390/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-11, 1390/03/21
Registrant information
Name
Seyed Alireza Seyed Siamdoust
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 1749
Email address
siamdoust.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the analgesic effect of Nitroglycerin added to lidocaine in intravenous regional anesthesia in hand Surgery.
Public title
Effect of Nitroglycerin added to lidocaine in bier block
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 60 ASA I and II patients; candidate for hand and forearm surgeries (tendon injuries); under 90 min; aging from 18 to 50 years. exclusion criteria: sickle cell anemia; hypersensitivity; G6PD; Raynaud's disease; drug abuse history and addiction; and open fracture.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Tehran University of Medical Sciences Ethics Committee
Street address
Shahid Hemmat Highway , Pardis Hemmat , Vice chancellor for research, Tehran University of Medical Sciences
City
Tehran
Postal code
1969714713
Approval date
2011-03-07, 1389/12/16
Ethics committee reference number
43107
Health conditions studied
1
Description of health condition studied
Injury of muscle and tendon at wrist and hand level
ICD-10 code
S66
ICD-10 code description
Injury of muscle and tendon at wrist and hand level
Primary outcomes
1
Description
Sensory block onset time
Timepoint
Every thirty seconds to completion of sensory block.
Method of measurement
Shortbeveled needle.
2
Description
Motor block onset time
Timepoint
Every thirty seconds to completion of motor block.
Method of measurement
Asking the subject to flex and extend his wrist and fingers.
3
Description
Sensory recovery time
Timepoint
Every thirty seconds to return of sense in hand.
Method of measurement
Shortbeveled needle
4
Description
Motor block recovery time
Timepoint
Every thirty seconds to complete movement of wrist.
Method of measurement
Movement of wrist
Secondary outcomes
1
Description
Tourniquet time
Timepoint
Every 20 minutes to start of pain.
Method of measurement
Visual analog scale (VAS) (0 cm _ “no pain” and 10 cm _ “worst pain imaginable.
2
Description
Need to fentanyl
Timepoint
At the end of the surgery.
Method of measurement
Microgram
Intervention groups
1
Description
Adding 200 microgram TNG plus 3 mg/kg lidocaine 2% dilute in 40 ml salin in nitroglycerine group.
Category
Treatment - Drugs
2
Description
Adding salin 40 ml as Placebo to 3 mg/kg lidocaine 2% in control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Seyed Ali Reza Seyed Siamdoust
Street address
19 Ave . Seyed Jamal Aldine Asadabadi St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi
Street address
Shahid Hemmat Highway , Tehran University of Medical Sciences
City
Tehran
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, Tehran 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
Tehran University Of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Resident
Other areas of specialty/work
Street address
401 Apt. , 7 Block , 20 Ave. , Velenjak St.
City
Tehran
Postal code
Phone
+98 21 2242 1841
Fax
Email
pooyaderakh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Reza Seyed Siamdoust
Position
Assistant Professor
Other areas of specialty/work
Street address
Satarkhan St. , Niyayesh St. , Rasool Hospital.
City
Tehran
Postal code
Phone
+98 21 6651 6005
Fax
Email
sasiamdoust@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Resident
Other areas of specialty/work
Street address
No. 7 , 20 St. , Velenjak.
City
Tehran
Postal code
Phone
+98 21 2242 1841
Fax
Email
pooyaderakh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)