Protocol summary

Summary
The purpose of study is to compare the success rate of infraclavicular block by both sonography and nerve stimulations methods concurrently and each alone. This study is non-random, double blind and without control or placebo that is run at one center and the patients who are persenting to Shohada Ashayer hospital and are going undergo elective surgery of forearm, elbow,wrist and hand with infraclavicular nerve block And was chosen by simple non-random method that randomly divided into three groups: Sonography, nerve stimulation, sonography and nerve stimulation Inclusion criteria:patients aged 18-85 years, I and III classes of ASA(ps-1 & ps-3), consent to participate in the project. Exclusion criteria: patients with allergies to anesthesia, local infection at injection site and coagulopathy, neurological disorders in upper limb ends, recognizable psychotic disorders, cognitive disorders, drug abuse background, long- term use of epioids, severe cardiopulmonary, diabetes, recognized neuropathy, dissatisfaction to participate in the project.Sample size was 90 people. Success rate of infraclavicular block by both sonography and nerve stimulation methods concurrently and each alone. The primary outcome quick start of numbness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016090716066N5
Registration date: 2016-10-09, 1395/07/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-09, 1395/07/18
Registrant information
Name
Siavash Beiranvand
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1221 5006
Email address
dr.beiranvand@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences, Research deputy and Technology
Expected recruitment start date
2016-10-08, 1395/07/17
Expected recruitment end date
2017-05-07, 1396/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the success rate of infraclavicular block by concurrent sonography and nerve stimulation methods
Public title
The effect of sonography and nerve stimulation in Upper limbs nerver block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion conditions: patients aged 18-85 years; I and III classes of ASA(ps-1 & ps-3); consent to participate in the project. Exclusionconditionsb:patients with allergies to anesthesia; local infection at injection site and coagulopathy; neurological disorders in upper limb ends; recognizable psychotic disorders; cognitive disorders; drug abuse background; long-term use of epioids; severe cardiopulmonary; diabetes,recognized neuropathy; dissatisfaction to participate in the project.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
Deputy of Research and Technology, Integrated Pardis, Lorestan University of Medical Sciences, 5 Km Road Khorramabad -Tehran, Khorramabad
City
Khorramabad
Postal code
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
LUMS.REC.1395.91

Health conditions studied

1

Description of health condition studied
Brachial plexus anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics

Primary outcomes

1

Description
numb
Timepoint
Since the injection to numbness
Method of measurement
Stopwatch

2

Description
Immobility
Timepoint
Since the injection to immobility
Method of measurement
stopwatch

Secondary outcomes

1

Description
Blood pressure values after operation
Timepoint
During operation untill recovery
Method of measurement
monitoring

2

Description
Heart beat amount
Timepoint
During operation untill recovery
Method of measurement
monitoring

3

Description
Intraoperative bleeding amount
Timepoint
Since the beginning to end of operation
Method of measurement
observational

4

Description
Post-operative pain amount
Timepoint
Since anesthesia to recovery
Method of measurement
Based on the VAS scale

5

Description
Extubate time
Timepoint
After operation
Method of measurement
stopwatch

6

Description
Duration of anesthesia
Timepoint
Intraoperative
Method of measurement
stopwatch

7

Description
Duration of anesthasia
Timepoint
Since the beginning of injection to recovery
Method of measurement
stopwatch

8

Description
Opening eyes
Timepoint
After operation
Method of measurement
observation

Intervention groups

1

Description
sonography on the block infraclavicular before surgery in control group
Category
Treatment - Other

2

Description
Success rate of infraclavicular block by sonography method before surgery in Intervention group
Category
Treatment - Other

3

Description
nerve stimulation in infraclavicular block before surgery in control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Ashayer Hospital Khorramabad
Full name of responsible person
dr.siavash beiranvand
Street address
Department Of Anesthesiology, Shohada Ashayer Hospital,Enghelab street, Khorramabad
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr.Morovat Tahari Kalani
Street address
Deputy of Research and Technology, Complex Pardis, Lorestan University of Medical Sciences,Khorramabad
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University Of Medical Sciences
Full name of responsible person
Dr.Siavash Bieravand
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, Ashayer Shohada Hospital, Enghelab street, Khorramabad
City
Khorramabad
Postal code
Phone
+98 66 3312 0715
Fax
Email
beiranvandsiavash@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr.Siavash Beiranvad
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, Shohada Ashayer Hospital, Enghelab Street Khorramabad
City
Khorramabad
Postal code
Phone
+98 66333323004
Fax
Email
beiranvandsiavash@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University Of Medical Sciences
Full name of responsible person
Elham Shikhey
Position
BS In Clinical Research
Other areas of specialty/work
Street address
Clinical Research, Shohada Ashayer Hospetal, Enghelab Street, khorramabad
City
Khorramabad
Postal code
Phone
+98 66 3312 0175
Fax
Email
nedaesh1@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
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