Evaluation and compare the onset of sciatic nerve block in injection common proneal nerve and tibial individually against injection in proximal to the bifurcation of sciatic nerve
The purpose of study is evaluation and compare the onset of sciatic nerve block in injection common proneal nerve and tibial individually against injection in proximal to the bifurcation of sciatic nerve. 66 patients undergoing surgery which is done under knee reffered to Hazrat Rasool Hospital as a random, double-blind, and without control with placebo with 1-2 trial phase with using sealed envelopes and on parallel divided into two groups.Patient's age must be over 20 years of age and ASA have one to three and patients with peripheral vascular disease, peripheral neuropathy, Patient's block does not complete within 30 minutes will be excluded. In the first group injection is performed in place before the bifurcation of the sciatic nerve (sciatica groups called) And the second group the common proneal nerve and tibial nerve injection separately takes (Tibial-proneal group is called). After administration of local anesthetics, sensory and motor block is evaluated. Time Imaging of contact time ultrasound probe until proper image to be seen to be measured. In each person the number of needles that inserted is estimated and side effects included paresthesia and perforation of the vessel is registered.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110212642N20
Registration date:2015-11-21, 1394/08/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-21, 1394/08/30
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, Iran University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-11-30, 1394/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and compare the onset of sciatic nerve block in injection common proneal nerve and tibial individually against injection in proximal to the bifurcation of sciatic nerve
Public title
evaluation and compare the onset of sciatic nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient 20-70years old; Patient that hane unilateral surgery on foot; Patient with ASA I-III; Exclusion criteria: Patient with history of diabetes; Pripheral nerve disease; pripheral neuropathy; pregnancy; Patient's block does not complete within 30 minutes.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is performed using sealed envelopes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Postal code
Approval date
2015-07-20, 1394/04/29
Ethics committee reference number
IR.IUMS.REC.1394.9111174014
Health conditions studied
1
Description of health condition studied
nerve block
ICD-10 code
Y48.3
ICD-10 code description
adverse of therapeutic use
Primary outcomes
1
Description
The completion time of sensory block
Timepoint
The first time, 10 minutes after the block and after that at intervals of 5 minutes.
Method of measurement
Table defined and based on minutes
2
Description
The completion time of motor block
Timepoint
The first time, 10 minutes after the block and after that at intervals of 5 minutes.
Method of measurement
Table defined based on minutes
Secondary outcomes
1
Description
Imaging time
Timepoint
After block
Method of measurement
The contact time ultrasound probe until proper image is visible on the map and based on minute
2
Description
Needling time
Timepoint
After block
Method of measurement
Since contact with the skin until the injection of local anesthetic needle and based on minute
Intervention groups
1
Description
In the first group, the sciatic nerve block with will done with 15 ml of Marcaine 0.5% and 15 cc of 1% lidocaine in common proneal nerve and tibial nerve separately.
Category
Treatment - Other
2
Description
In the second group, the sciatic nerve block with 15 ml injection of Marcaine 0.5% and 15 cc of 1% lidocaine injection proximal to the bifurcation takes place.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Poopak Rahimzadeh
Street address
Satarkhan Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Alijavad Musavi
Street address
Vice chancellor for research of Iran University of Medical Sciences, 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
Vice chancellor for research, 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology group of Iran University of Medical Science
Full name of responsible person
Poopak Rahimzadeh
Position
Fellowship of pain
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Satarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 5001
Fax
Email
p-rahimzadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology group of Shahid beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Anesthesiologist
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)