Comparison of ultrasound guided axillary brachial plexus block techniques: Perineural injection of brachial plexus versus single or double perivascular infiltration
Comparison of methods of axillary blockage of brachial plexus with ultrasound guidance
Design
Community based and pragmatic clinical trial with parallel groups
Settings and conduct
Injection of lidocaine 1% solution in the operating room of Shahid Beheshti Hospital in Babol by anesthesiologist and evaluation of the procedure time, block time and induction of anesthesia every 3 minutes up to 15 minutes after the block
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing upper limb surgery
Conditions of non compliance: pregnant patients, coagulation disorders, localized infection, history of local anesthetic hypersensitivity
Intervention groups
Intervention group 1: single injection of Lidocaine 1% with epinephrine 1: 200,000 plus bicarbonate along the radial, median and ulnar nerves with ultrasonography guidance.
Intervention group 2: single injection of Lidocaine 1% with epinephrine 1: 200,000 plus bicarbonate at 12 o'clock around the axillary artery with ultrasonography guidance.
Intervention group 3: dual injection of Lidocaine 1% with epinephrine 1: 200,000 plus bicarbonate at 6 and 12 O'clock around the axillary artery with ultrasonography guidance.
Main outcome variables
The duration of the block (from the needle is inserted into the skin until the needle is removed from the skin); The degree of the sensory and motor block; Onset time (from the needle is removed to the complete block and allowing for the start of surgery); Induction time (from needle insertion to complete sensory and motor block)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160926029976N4
Registration date:2019-02-19, 1397/11/30
Registration timing:retrospective
Last update:2019-02-19, 1397/11/30
Update count:0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Reza Mohseni Ahangar
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8301
Email address
r.mohseni@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2019-01-21, 1397/11/01
Trial completion date
2019-01-21, 1397/11/01
Scientific title
Comparison of ultrasound guided axillary brachial plexus block techniques: Perineural injection of brachial plexus versus single or double perivascular infiltration
Public title
Brachial plexus block in Axilla with ultrasound guidance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for upper limb surgery lower than elbow
Exclusion criteria:
pregnancy
Coagulation disorders
Infection in the site of the blockage
History of local anesthetic hypersensitivity
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not 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
Ethics Committee of Babol University of Medical Sciences
Street address
Babol university of medical science, Parastar Square, Keshavarz Blvd, Babol
City
Babol
Province
Mazandaran
Postal code
4717995915
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.215
Health conditions studied
1
Description of health condition studied
Acquired deformity of musculoskeletal system, unspecified
ICD-10 code
M95.9
ICD-10 code description
Acquired deformity of musculoskeletal system, unspecified
Primary outcomes
1
Description
Duration of the blockage
Timepoint
3 minutes after the intervention
Method of measurement
clock
2
Description
Degree of sensory and motor block
Timepoint
3 minutes after the intervention
Method of measurement
pinprick test
3
Description
Onset time of block
Timepoint
3 minutes after the intervention
Method of measurement
clock
4
Description
Induction time
Timepoint
3 minutes after the intervention
Method of measurement
clock
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Injection of solution of Lidocaine 1% with epinephrine 1:200,000 plus bicarbonate around the radial, ulnar and median nerve under the direction of ultrasound
Category
Treatment - Drugs
2
Description
Intervention group 2: Injection of solution of Lidocaine 1% with epinephrine 1:200,000 plus bicarbonate around the axillary artery at 12 o clock under the direction of ultrasound
Category
Treatment - Drugs
3
Description
Intervention group 3: Injection of solution of Lidocaine 1% with epinephrine 1:200,000 plus bicarbonate on both sides of the axillary artery at 6 and 12 o clock under the direction of ultrasound
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Mostafa Molaie
Street address
Rohani hospital, keshavarz boulevard
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
r.mohseni@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University Of Medical Sciences, Ganjafrooz Street, Babol
City
Babol
Province
Mazandaran
Postal code
4717995915
Phone
+98 11 3219 9592
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mostafa Molaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rohani hospital, Keshavarz Blvd
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8309
Email
dr.mola.ghara@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mostafa Molaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rohani hospital, Keshavarz Blvd
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8309
Email
dr.mola.ghara@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mostafa molaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rohani hospital, Keshavarz Blvd
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8309
Email
dr.mola.ghara@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available