Background and Objectives: Studies showed that Verapamil as a Calcium channel blocker potentiates the analgesic effects of local anesthesia. In this study, we evaluated two doses of Verapamil (5 and 10 mg) in combination with Lidocaine on quality of local axillary blockage in comparison with placebo. Methods: Present study was a double blind randomized controlled clinical trial. Ninety two patients candidate for upper limb orthopedic and plastic surgery with axillary block will enroll the study and divide in three groups randomly. In group A, The patients will receive only Lidocaine 1.5%; in group B, The patients will receive Verapamil 5 mg plus Lidocaine 1.5%; and in group C, The patients will receive Verapamil 10mg plus Lidocaine 1.5%.Time of onset and duration of analgesia, sympathetic, sensory and motor blocks as well as hemodynamic changes will be evaluated in these three groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903094050N1
Registration date:2010-06-13, 1389/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-13, 1389/03/23
Registrant information
Name
Kambiz Sadegi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7798 5238
Email address
fsadegi@put.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2008-10-22, 1387/08/01
Expected recruitment end date
2009-10-23, 1388/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of Effect of Addition of Different Doses of Verapamil to 1.5% Lidocaine on Sensory and Motor Axillary Block
Public title
The Evaluation of Effect of Addition of Different Doses of Verapamil to 1.5% Lidocaine on Sensory and Motor Axillary Block
Purpose
Treatment
Inclusion/Exclusion criteria
INCLUSION CRITERIA: 1) Upper extrimities surgery including: Hand, Wrist & Forearm 2) Age upper than 18 & lower than 45 3) ASA I & II (American Society of Anesthesia 1 & 2 ) 4) Patient's consent to enter the studyEXCLUSION CRITERIA: 1) Underlying diseases (Hypertension, Diabetes mellitus, Liver diseases, Renal diseases, Coagulopathy) 2) Addiction (opioids & Alcohol) 3)Not consent to enter the study 4) Morbid obesity (weight more than 115 kg) 5)Allergy to local anesthetic drugs 6) Peripheral neuropathy 7) Local infection at injection site 8) Pregnancy
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
92
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
Iran University of Medical Sciences
Street address
Shahid Hemmat highway
City
Tehran
Postal code
Approval date
2009-09-01, 1388/06/10
Ethics committee reference number
45106
Health conditions studied
1
Description of health condition studied
regional anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation the time of onset & duration of sympathetic block
Timepoint
Interval time: 0,5,10,15,20,30,45,60,75 minutes & every 15 minutes thereafter after blocking
Method of measurement
Sympathetic block: Alcohol test
2
Description
Evaluation the time of onset & duration of sensory & motor block
Timepoint
Interval time: 0,5,10,15,20,30,45,60,75 minutes & every 15 minutes thereafterafter blocking
Method of measurement
Sensory block: Pin prick test/ Motor block: Fingers movement
3
Description
Evaluation the duration & quality of analgesia
Timepoint
Interval time: 0,5,10,15,20,30,45,60,75 minutes & every 15 minutes thereafter after blocking and for analgesia 2,4,6,12 ,24 houres in recovery and thereafter
Method of measurement
Analgesia: VAS score
Secondary outcomes
1
Description
Blood pressure (systolic, disatolic)
Timepoint
Just before & after & 15, 30, 45, 60 minutes after axillary block & at the end of surgery and in recovery
Method of measurement
Non invasive blood pressuer automatic monitoring
2
Description
mean arterial pressure
Timepoint
Just before & after & 15, 30, 45, 60 minutes after axillary block & at the end of surgery and in recovery
Method of measurement
Non invasive blood pressuer automatic monitoring
3
Description
Heart Rate
Timepoint
Just before & after & 15, 30, 45, 60 minutes after axillary block & at the end of surgery and in recovery
Method of measurement
Non invasive blood pressuer & Heart rate automatic monitoring
Intervention groups
1
Description
Group A, The patients will receive only 34cc Lidocaine 1.5%
Category
Treatment - Other
2
Description
Group C, The patients will receive Verapamil 10 mg plus 34cc Lidocaine 1.5%
Category
Treatment - Drugs
3
Description
Group B, The patients will receive Verapamil 5mg plus 34cc lidocaine 1.5%.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Fatemeh Hospital
Full name of responsible person
Street address
Seied Jamaledine Asad Abadi St. - Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Street address
Sattar Khan St. - Niaiesh St.- Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Street address
Shahid Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Hazrat Rasool Akram Hospital
Full name of responsible person
Kambiz Sadegi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
No.144 - BouAli St. - Tehran nou - Tehran
City
Tehran
Postal code
Phone
+98 21 7798 5238
Fax
Email
kamsadegi@yahoo.co.uk; fsadegi@put.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hazrat Rasool Akram Hospital
Full name of responsible person
Kambiz Sadegi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
No.144 - BouAli St. - Tehran nou - Tehran
City
Tehran
Postal code
Phone
+98 21 7798 5238
Fax
Email
kamsadegi@yahoo.co.uk; fsadegi@put.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hazrat Rasool Akram Hospital
Full name of responsible person
Kambiz Sadegi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
No.144 - BouAli St. - Tehran nou - Tehran
City
Tehran
Postal code
Phone
+98 21 7798 5238
Fax
Email
kamsadegi@yahoo.co.uk
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)