The aim of this study was Comparing the level of sensory-motor effect of bupivacaine 5/0% and lidocaine5% in spinal anesthesia. In a double-blind clinical trial, 64 patients were undergoing spinal anesthesia were randomize into two groups. Inclusion criteria: Patients between 17 to 70 years old with lower limb fracture and; exclusion criteria: dissatisfaction of patient to participate in the spinal anesthesia. Group1: 3ml of hyperbaric bupivacaine 0.5%; group 2: 2ml of hyperbaric lidocaine5%. In the determined minutes, hemodynamic changes and sensory and motor levels (abdominal, knee and ankle) have been measured in patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012073010340N5
Registration date:2012-09-13, 1391/06/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-13, 1391/06/23
Registrant information
Name
Mohammad Aryaie
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 277 1798
Email address
aryaie@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan university of medical sciences
Expected recruitment start date
2010-03-16, 1388/12/25
Expected recruitment end date
2012-05-14, 1391/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the level of sensory-motor effect of bupivacaine 5/0% with lidocaine5% in spinal anesthesia
Public title
Comparing the level of sensory-motor between two drugs (lidocaine5% and bupivacaine0.5%) in spinal anesthesia
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 17 to 70 years old with lower limb fracture with ASA class I and II. Exclusion criteria: dissatisfaction of patients to participate in the spinal anesthesia and those who are suffering from vertigo and if the organs won’t get numb in spinal anesthesia.
Age
From 17 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Golestan university of medical sciences
Street address
Golestan university of medical sciences
City
Gorgan
Postal code
Approval date
2012-07-28, 1391/05/07
Ethics committee reference number
9100507167
Health conditions studied
1
Description of health condition studied
spinal anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
level of sensoy
Timepoint
during surgery and recovery
Method of measurement
alcohol cotten
Secondary outcomes
1
Description
level of motor
Timepoint
during of surgery and recovery
Method of measurement
ask from patient
Intervention groups
1
Description
Group1: 3ml of hyperbaric bupivacaine 0.5% was injected
Category
Other
2
Description
Group2: 2ml of hyperbaric lidocaine5% was injected
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
5th azar hospital
Full name of responsible person
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Dr. Mohammad Vakili (Director of Research and Technology)
Street address
Kilometer 2 of road of Sari, Golestan University of Medical Sciences
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Science
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
5th of azar hospital
Full name of responsible person
Kazem Kazem nejad
Position
anesthesiologist
Other areas of specialty/work
Street address
5th of azar hospital, 5azar street, Kakh squre
City
Gorgan
Postal code
Phone
+98 17 1277 1798
Fax
Email
kazemnejad1341@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Mohammad Aryaie
Position
master degree
Other areas of specialty/work
Street address
5th of azar hospital
City
Gorgan
Postal code
Phone
+98 17 1442 1651
Fax
Email
aryaiem2009@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
golestan university of medical sience
Full name of responsible person
Amin Hasanzad
Position
bachelor degree
Other areas of specialty/work
Street address
5th azar hospital
City
Gorgan
Postal code
Phone
+98 17 1995 6327
Fax
Email
amin_hassanzad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)