Purpose: Comparison of hand nerve block success in order to pain management in emergency department with and without sonography. Type of study: Randomize clinical trial single blind for patients. Sample: All patients over 18 years old with isolated hand trauma. Patients will exclude from the study if they have previous hand deformity or other trauma or analgesic usage or dissatisfaction to join the study. Main intervention: Nerve block with sonography. Studying results: The success rate of nerve block (according to the numbness of blocked nerve with sense examination) and patient satisfaction. Method: Patients will divide in to 2 groups alternately. Sample size for each group is 143 patients. In one group, in a sterile situation the nerve will be blocked under sonographic guide and in the other group, the nerve will be localized with anatomical landmarks and will be blocked in sterile situation. The success of nerve block will be assessed by pinprick test. Nerve block will be unsuccessful if the patient sense the needle over his or her skin and then other type of indolence will be used for the patient. These patients will not be excluded from the final analysis and will be remained in their group. Patient's information will be recorded in designed questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090329677N1
Registration date:2017-02-16, 1395/11/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-16, 1395/11/28
Registrant information
Name
Toktam Mohammadi Rana
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 985136096417
Email address
moammadirt931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Radial,Ulnar and Median nerve block success with and without sonographic guide for pain control in emergency department
Public title
Hand nerves block with and without sonographic guide for pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18; Isolated hand deformity; No previous hand deformity Exclusive criteria: Multiple trauma; Analgesic usage for any reason; Wound at the site of nerve block; Dissatisfaction to join the study
Age
From 18 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
286
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
Ethics of Mashhad University of Medical Science
Street address
Daneshgah St. Next to Hoveyzeh Cinema. Medical University of Mashhad. Technical and Investigation Faculty
City
Mashhad
Postal code
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
1394.685
Health conditions studied
1
Description of health condition studied
Local nerve block
ICD-10 code
S60,S61,S6
ICD-10 code description
INJURIES TO THE WRIST AND HAND
Primary outcomes
1
Description
Painlessness
Timepoint
10 min after block
Method of measurement
Revision of painlessness with Pinprick test
Secondary outcomes
empty
Intervention groups
1
Description
Local Median, Radial and Ulnar nerves block with Lidocain 2% after localizing the nerve with sonography
Category
Treatment - Other
2
Description
Local Median, Radial and Ulnar nerves block with Lidocain 2% after localizing the nerve with anatomical landmarks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza Hospital
Full name of responsible person
Dr Toktam Mohammadi Rana
Street address
City
Mashhad
2
Recruitment center
Name of recruitment center
Hasheminezhad Hospital
Full name of responsible person
Dr Toktam Mohammadi Rana
Street address
Vahid St.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Next to Hoveyzeh Cinema, Daneshgah St
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences