Comparison of some parameters related to pain in patients with proximal femur fractures in both femoral nerve block methods using ultrasound guide and neural stimulation
The aim of present study was to compare some parameters related to pain in patients with proximal femoral fractures in both femoral nerve block methods using ultrasound guide and neural stimulation. The inclusion criteria was all the patients with proximal femoral fracture aging between 18-80. The Exclusion criteria included patients with contraindications for administration of local anesthetics or opioids; lack of ability to respond to Visual Analog Scale for Pain;... . Patients were randomly divided into two groups. Femoral nerve block was performed in a group using ultrasound guide and in the other group with nerve stimulation technique. In both groups the duration of procedure of local block, time of beginning of effect of local anesthesia after injection, the rate of success, duration of block, the difference of pain after block (based on a visual analogue scale of pain), the amount of additional doses of opioids more than 0.1 mg per kg (in case of an insufficient response), the amount of morphine were evaluated in all patients and the results will compared in both groups. In our study, the blinding will performed on information monitoring committee.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030221289N1
Registration date:2015-12-02, 1394/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Akram Rohani Marvasti
Name of organization / entity
Ahvaz,Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 7207
Email address
rohani.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz, Jundishapur University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of some parameters related to pain in patients with proximal femur fractures in both femoral nerve block methods using ultrasound guide and neural stimulation
Public title
The effect of sonography in femoral nerve block
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: all the patients with proximal femoral fracture aging between 18-80 years old. Exclusion criteria: patients with contraindications for administration of local anesthetics or opioids; lack of ability to respond to Visual Analog Scale for pain; patients with cognitive disorder or GCS below 15; having a history of old fracture or metallic device in femur; addiction to opioids, chronic heart and lung disease; diabetes; coagulopathy; lack of response to local anesthesia.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz, Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan highway, Ahvaz, Khuzestan
City
Ahvaz
Postal code
6135715794
Approval date
2014-06-16, 1393/03/26
Ethics committee reference number
1393.178
Health conditions studied
1
Description of health condition studied
Proximal femoral fracture
ICD-10 code
S72
ICD-10 code description
Fracture of femur
Primary outcomes
1
Description
Pain scale in femoral nerve block
Timepoint
0, 5, 15, 30 and 60 minutes after femoral nerve block
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Duration of procedure of local block, time of beginning of effect of local anesthesia after injection, the rate of success, duration of block, the amount of morphine
Timepoint
At the beginning and 60 minutes after the nerve block
Method of measurement
Monitor and measure
Intervention groups
1
Description
Femoral nerve block with ultrasound, 20 ml of 1% lidocaine, intravenous morphine simultaneously with 0.1 mg/kg morphine
Category
Treatment - Other
2
Description
Femoral nerve block with nerve stimulation, 20 ml of 1% lidocaine, intravenous morphine simultaneously with 0.1 mg/kg morphine
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Imam Khomeini Hospital
Full name of responsible person
Akram Rohani Marvasti
Street address
City
Ahvaz
2
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Akram Rohani Marvasti
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Akram Rohani Marvasti
Street address
Jundishapur University of Medical Sciences, Golestan highway, Ahvaz, Khuzestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapur 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
Ahvaz, Jundishapur University of Medical Sciences
Full name of responsible person
Akram Rohani Marvasti
Position
Resident
Other areas of specialty/work
Street address
Jundishapur University of Medical Sciences, Golestan highway, Ahvaz, Khuzestan
City
Ahvaz
Postal code
61357-15794
Phone
+98 61336754360
Fax
Email
info@ajums.ac.ir
Web page address
http://www.ajums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz, Jundishapur University of Medical Sciences
Full name of responsible person
Arash Forozan
Position
Assistant professor
Other areas of specialty/work
Street address
Jundishapur University of Medical Sciences, Golestan highway, Ahvaz, Khuzestan
City
Ahvaz
Postal code
6135715794
Phone
+98 61336754360
Fax
Email
info@ajums.ac.ir
Web page address
http://www.ajums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz, Jundishapur University of Medical Sciences
Full name of responsible person
Akram Rohani Marvasti
Position
Resident
Other areas of specialty/work
Street address
Jundishapur University of Medical Sciences, Golestan highway, Ahvaz, Khuzestan
City
Ahvaz
Postal code
61357-15794
Phone
+98 61336754360
Fax
Email
info@ajums.ac.ir
Web page address
http://www.ajums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)