Evaluation of the success rate of hematoma block with and without ultrasound-guide in pain control of distal radial fracture reduction in patients presenting to the emergency department
After obtaining ethics committee’s approval for patients with distal radial fracture to Imam Reza hospital, based on inclusion criteria and obtaining informed consent were enrolled. Information including age, sex, drug history, previous and acute fracture is collected by a checklist. In this double blind clinical trial, 80 patients with acute fracture of distal radius from among ASA class 1 and 2 and older than 18 years select and were randomly divided into 2 groups: hematoma block without ultrasound guidance (A) and hematoma block with ultrasound guidance (B). In A group, after disinfection, lidocaine 1% is injected in the center of the hematoma and around ulnar styloid with Barbutazh technique. In B group at first we identify hematoma with ultrasound and then injection is done. Ten minutes after anesthesia block is proved by asking the patient and the pressure at the site of block then reduction is performed. Injection is done by research supervisor who is unaware about the method of choosing the site of injection. Pain during hematoma block and reduction is measured on the base of visual analogue scale. The method of evaluation is explained to the patient before and after injection. Patient satisfaction about analgesia is measured at the time of block and 30 minutes after according to the method as described method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020126315N1
Registration date:2016-06-04, 1395/03/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-04, 1395/03/15
Registrant information
Name
Assiyeh Baradaran fard
Name of organization / entity
Mashhad University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 51 3767 0588
Email address
baradaranfa921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
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
Evaluation of the success rate of hematoma block with and without ultrasound-guide in pain control of distal radial fracture reduction in patients presenting to the emergency department
Public title
Evaluation of the success rate of hematoma block with and without ultrasound-guide in pain control of distal radial fracture reduction in patients presenting to the emergency department
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Patients with acute fractures of the distal forearm ASA class I and II and among people over the age of 18 years
Exclusion criteria: Older fractures than 12 hours; Open fractures due to technical problem; Patients with a history of drug abuse or any kind of debilitating CNS and respiratory medications
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, randomization is made with random numbers table in patients above 18 years with acute distal radius fracture.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Pardis of Ferdowsi University, Azadi squrare, Mashhad
City
Mashhad
Postal code
917794-8564
Approval date
2015-06-10, 1394/03/20
Ethics committee reference number
IR.MUMS.sm.REC.1394.132
Health conditions studied
1
Description of health condition studied
Fracture of the distal radius
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius
Primary outcomes
1
Description
pain score
Timepoint
before block, 30 minutes after reduction
Method of measurement
visual analog scale
Secondary outcomes
1
Description
reducton time
Timepoint
reduction time
Method of measurement
minute
Intervention groups
1
Description
In A group, hematoma block without ultrasound guidance, after disinfection, lidocaine 1% is injected in the center of the hematoma and around ulnar styloid with Barbutazh technique. Ten minutes after anesthesia block is proved by asking the patient and the pressure at the site of block then reduction is performed. Injection and reduction are done by research supervisor. Pain during hematoma block and reduction, is measured on the base of visual analogue scale by research fellow who is unaware about the method of choosing the site of injection. The method of evaluation is explained to the patient before and after injection. Patient satisfaction about analgesia is measured at the time of block and 30 minutes after according to the method as described method.
Category
Diagnosis
2
Description
In B group, hematoma block with ultrasound guidance, at first we identify hematoma with ultrasound and after disinfection, lidocaine 1% is injected in the center of the hematoma and around ulnar styloid with Barbutazh technique. Ten minutes after anesthesia block is proved by asking the patient and the pressure at the site of block then reduction is performed. Injection and reduction are done by research supervisor. Pain during hematoma block and reduction, is measured on the base of visual analogue scale by research fellow who is unaware about the method of choosing the site of injection. The method of evaluation is explained to the patient before and after injection. Patient satisfaction about analgesia is measured at the time of block and 30 minutes after according to the method as described method.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Imam Reza (AS) hospital
Full name of responsible person
Dr. Assiyeh Baradaran Fard
Street address
Edalatian emergency department, Imam Reza (AS) hospital, Ibn Sina street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences Vice chancellor for research
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences Vice chancellor for research
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Assiyeh Baradaran Fard
Position
Resident of emergency medicine
Other areas of specialty/work
Street address
Edalatian emergency departmet, Imam Reza Hospital, Ibn Sina street