Protocol summary

Summary
The aim of research: comparison of femoral nerve block and intravenous morphine in pain control and time of pain control in femur fracture in Emergency Department. Design: non randomized control trial- Interventional- without placebo- multi central. Population of research: patients with femoral fractured in Emergency Department. Sample size: 60 patients. Intervention: femoral nerve block in comparison with intravenous morphine. Time of research: minutes 0, 5, 30 and 60. Primary outcome: pain control.

General information

Acronym
Emergency Department-ED - Femural Nerve Block-FNB - Morphin Sulfate -MS
IRCT registration information
IRCT registration number: IRCT2014041717316N1
Registration date: 2014-05-29, 1393/03/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-29, 1393/03/08
Registrant information
Name
Narges Yadegar
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 4268
Email address
yadegar.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University Of Medical Sciences
Expected recruitment start date
2012-07-27, 1391/05/06
Expected recruitment end date
2014-02-25, 1392/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of femoral nerve block and IV morphine in pain control and time of pain control in femur fracture in Emergency Department
Public title
Pain control in femoral fractures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterion: all of patients who incoming Emergency Department with chief complaint of femoral fracture. Exclusion criteria: other additional injuries except femoral fractures; allergy to morphine or lidocaine; medical illness that restricted use of morphine or lidocaine; patients inability to present his/her pain score with any reason.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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
Vice Chancellor for Research and Technology, Jundishapur University of Medical sciences, University City, Ahvaz, Khuzestan, Iran
City
Ahwaz
Postal code
6135715794
Approval date
2012-06-16, 1391/03/27
Ethics committee reference number
ajums.REC.1392.26

Health conditions studied

1

Description of health condition studied
Femur fracture
ICD-10 code
S72
ICD-10 code description
Fracture of femur

Primary outcomes

1

Description
Pain
Timepoint
Minutes 0 and after sedation
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Type of fracture
Timepoint
Minute 0 and after sedation
Method of measurement
By radiography

Intervention groups

1

Description
One group sedated with 0.1 mg per kg IV morphine
Category
Treatment - Drugs

2

Description
Other group sedated with femoral nerve block
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Narges Yadegar
Street address
Shahid Ahvazian avenue, 24 metri street, Ahvaz, Khuzestan, Iran
City
Ahvaz

2

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Narges Yadegar
Street address
Ahwaz-Golestan avenue-Golestan hospital
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Miss. Jaderi
Street address
Vice Chancellor for Research and Technology, Jundishapur University of Medical Sciencs, University city, Ahvaz, Khuzestan, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Narges Yadegar
Position
MD, resident
Other areas of specialty/work
Street address
Shahid Ahvazian avenue, 24 metri street, Ahvaz, khuzestan, Iran
City
Ahvaz
Postal code
Phone
+98 61 1222 2114
Fax
Email
yadegar.n@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Kambiz Masoumi
Position
Assistant professor
Other areas of specialty/work
Street address
Shahid Ahvazian avenue, 24 metri street, Ahvaz, Khuzestan, Iran
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 9166
Fax
Email
kami_masoumi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Narges Yadegar
Position
MD, resident
Other areas of specialty/work
Street address
Shahid Ahvazian avenue, 24metri street, Ahvaz, Khuzestan, Iran
City
Ahvaz
Postal code
Phone
+98 61 1222 2114
Fax
+98 61 1222 9166
Email
yadegar.n@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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