The purpose of this study is Comparison of the femoral block with fascia iliac block on the amount of painless in patients with femoral fracture during spinal anesthesia.52 patients admitted to Hazrat Rasool Hospital with a diagnosis of femoral fracture, as a randomized, double-blind, placebo-controlled Phase Karazmayy2-1 without using the sealed envelope and parallel divided into two groups. The first group undergo femoral block and the second group undergo fascia iliac block. Patients must be over 20 years old and have less than 75 years and is no emergent surgery. In case of convulsion after injection anesthetic solution or hematoma during block, patients will be excluded. Then the amount of pain and full time blocks in both groups will be compared with each other
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102712642N19
Registration date:2015-11-10, 1394/08/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-11-10, 1394/08/19
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
2015-11-22, 1394/09/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the femoral block with fascia ilica block on the amount of painless in patients with femoral fracture during spinal anesthesia
Public title
The effect of nerve block anesthesia on patients with femor fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 25 to 70 years old; ASA I-III; non emergent surgery; without coagulopathy; without peripheral neuropathy; without history of seizure Exclusion criteria: Incomplete block after 20 minutes; Seizure after anesthetic injection; Nausea and vomiting after anesthetic injection; Hematoma During the block
Age
From 20 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
How random is done using the enclosed envelope.
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
2014-07-21, 1393/04/30
Ethics committee reference number
105/1967/د/93
Health conditions studied
1
Description of health condition studied
Effect of nerve block on amount painless
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Time of anesthesia completion
Timepoint
After block with intervale 5minute
Method of measurement
with pin prick test and Cotton alcohol
2
Description
Block Qualility
Timepoint
After block with intervale 5minute
Method of measurement
The ability of the patient position for spinal anesthesia
Secondary outcomes
1
Description
severity of pain
Timepoint
after Block and with 1ntervale 5minutes
Method of measurement
Based on VAS
Intervention groups
1
Description
In the first group the patient in the supine position and after finding the femoral nerve with ultrasound 20 cc lidocaine 1/5% injected through the needle block.
Category
Treatment - Other
2
Description
In the second group the patient in the supine position and after finding the fascia iliaca with ultrasound 20 cc lidocaine 1/5% injected through the needle block.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Arash Memarian
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, 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, Iran University of Medical Sciences
Full name of responsible person
Poopak Rahim zadeh
Position
Fellowship of pain
Other areas of specialty/work
Street address
Hasrat Rasool Ave, Satarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 4001
Fax
Email
p-rahimzadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Surgery group, Iran University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship of Intensive care
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)