The aim of this study is to identify the appropriate way for painless procedure in induction of distal radius fractures. In this study hematoma block will be compared with neural block guided by sonography. Population study includes patients with distal radius fractures admitted into the Emergency Department. The sample size is 120, divided to equal two groups. The important inclusion criteria are age over 18y and without tissue damage and important exclusion criterion is allergy to lidocaine. The numerical pain score (VAS) will be measured before, during and after procedure to estimate pain state of the patient and will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111058000N1
Registration date:2012-12-15, 1391/09/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-15, 1391/09/25
Registrant information
Name
Nayereh Garjani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6649 9606
Email address
ngarjani@ymail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between hematoma block and median nerve block guided by sonography in reducing the pain caused by distal radius fracture
Public title
A comparison between neural block and nerve block guided by sonography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: GCS= 15; age >18 year; no mental disorder; no soft tissue injury; patients consent. Exclusion criteria: patients noncompliance; patients death due to injuries; Allergy to lidocaine; Distracting injury; no reducing in pain in any group
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Tehran university of medical siences
Street address
Qouds center, Qouds ave
City
Tehran
Postal code
Approval date
2012-04-17, 1391/01/29
Ethics committee reference number
130/2653/د/90
Health conditions studied
1
Description of health condition studied
distal radius fracture
ICD-10 code
S52.5
ICD-10 code description
Fracture of upper end of ulna
Primary outcomes
1
Description
pain
Timepoint
before procedure-ontime procedure-5min and 10 min and 15 min after procedure
Method of measurement
visual and numerical analog scale
Secondary outcomes
1
Description
side effect of procedure:arterial puncture,nerve puncture,hematoma
Timepoint
5min and 10min and 15min after procedure
Method of measurement
physical exam
Intervention groups
1
Description
15cc of 1/100 lidocaine is used for hematoma block in first group.
Category
Treatment - Other
2
Description
Radial and median nerve block, each of them with 15cc lidocaine guided by sonography is performed by a professional.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Dr. Saeed Abbasi ; Dr. Nayereh Garjani
Street address
Shahr-Ara, Satarkhan ave, Nyayesh st
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi
Street address
six floor, central office of university, cross Ghods St. and Keshavarz Blvd.
City
Tehran
Grant name
ندارم
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Saeed Abbasi
Position
Emergency Medicine Specialist/assistant Prof. of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Emergency Medicine Department, Rasoul Akram hospital
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
saieedabbasi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Saeed Abbasi
Position
Emergency Medicine specialist/Assistant Prof. of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Emergency medicine Department, Sina Hospital
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
saieedabbasi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Nayereh Garjani
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Emergency Medicine Department, Rasoul َkram Hospital
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
ngarjani@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)