Protocol summary

Summary
This study is a blinded randomized control trial.50 patients between 18 and 70 age old with distal radius fracture are included.After dividing them randomly in two groups,during the first 6 hours of admission,the intervention group will be blocked by a anesthesiologist. In favor of making a continuous block lasting for 48 hours,a pomp will be attached to the end of the catheter. This pomp will infuse the anesthetic drug continuously.The control group will not undergo any block. Both groups will be visited on 24hr, 72 hr ,first week,mounths 1 ,2 and 6 for pain assessment and evaluating complex regional pain syndrome.CRPS will be diagnosed based on IASP criteria and data will be analyzed by SPSS18.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110267919N1
Registration date: 2011-11-24, 1390/09/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-11-24, 1390/09/03
Registrant information
Name
Sadegh Saberi
Name of organization / entity
Orthopedics department, Imam khomeini Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2767
Email address
s_saberi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of continuous brachial plexus block at axillary level in preventing CRPS after distal radius fracture surgeries: a RCT
Public title
Effectiveness of nerve block in preventing complex regional pain syndrome after radius fracture surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : all distal radius fracture patients after pinning ; ages 16 to 70 ; ASAPS less than IV Exclusion criteria : concomitant fracture ; vessel involvement or compartment syndrome ; open fracture ; history of anti psychotic ,anti depressant , anti convulsant or corticosteroids drugs use ; history of psychotic or psychosomatic disease ; conversion disease ; chronic drug use ; high energy trauma ; need for open reduction ; contraindication for axillary block ; unsuccessful block exclusion a non successful block
Age
From 18 years old to 70 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
Research Assistant of Tehran University of Medical Sciences
Street address
Central organization of tehran university of medical sciences, Ghods street, Keshavarz boulvard
City
Tehran
Postal code
14167
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
90-03-30-14966

Health conditions studied

1

Description of health condition studied
Complex Regional Pain Syndrome
ICD-10 code
M89.0
ICD-10 code description
Shoulder-hand syndrome Sudeck's atrophy Sympathetic reflex dystrophy

2

Description of health condition studied
Distal Radius Fracture
ICD-10 code
s52.5
ICD-10 code description
Fracture of lower end of radius

Primary outcomes

1

Description
Complex Regional Pain Syndrome
Timepoint
one week , 1,2 and 6 mounths
Method of measurement
IASP criteria

2

Description
Sensory and motor block of upper limb
Timepoint
0.5 , 2,4,6,12,24,48 hour
Method of measurement
VAS criteria and history taking

Secondary outcomes

1

Description
nerve block complications
Timepoint
0.5 ,2,4,6,12,24,48 hours
Method of measurement
history taking nd examination

Intervention groups

1

Description
intervention group : axillary nerve block
Category
Prevention

2

Description
control group : no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Emrgency Department of Imam Khomeini Hospital
Full name of responsible person
Dr. Sadegh Saberi
Street address
Imam Khomeini Hospital , Dr Gharib street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sadegh Saberi
Street address
4th floor, Orthopedics Department , Imam Khomeini Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Bahar Hassanmirzaei
Position
Medical Student
Other areas of specialty/work
Street address
Orthopedics Department , Imam Khomeini Hospital
City
Tehran
Postal code
14568
Phone
+98 21 6119 2767
Fax
Email
bahariane@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 Sadegh Saberi
Position
Orthopedics Surgen
Other areas of specialty/work
Street address
Orthopedics Department , Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6119 2767
Fax
Email
s_saberi@sina.tums.ac.irsadeghsaberi@yahoo.combahariane@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
Bahar Hassanmirzaei
Position
Medical Student
Other areas of specialty/work
Street address
City
Tehran University of Medical Sciences, Poursina Street, Keshavarz Boulvard
Postal code
Phone
+98 21 6119 2767
Fax
Email
bahariane@yahoo.com
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
Loading...