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The effect of ultrasound guided intercostobrachial nerve block on tourniquet pain in patients undergoing axillary block in soft arm and forearm surgery

Protocol summary

Study aim
Determining the effect of ultrasound guided intercostobrachial nerve block on onset and severity of tourniquet pain in axillary block
Design
Randomized clinical trial with control group on three parallel groups, using random number table, simple sampling, sample size of 60 patients.
Settings and conduct
After monitoring and sedation, the ultrasound guided axillary block is performed with an injection of 30 ml of 1.5% lidocaine. Group1: The ultrasound guided intercostobrachial nerve block using a 2 cc of 1.5% lidocaine. Group2: intercostobrachial nerve block using conventional method without ultrasound by injecting 2 cc of 1.5% lidocaine. Group3: without intercostobrachial nerve block For all three groups, the tourniquet is closed at the arm before surgery and the tourniquet pressure is set at 100 mmHg above the systolic pressure. The patient's first reaction to the onset of tourniquet pain and its severity is recorded based on the patient's expression and VAS scoring. Pain assessment is performed on the subjects by an individual other than the block performer. Tourniquet pain assessment intervals are every 15 minutes after filling the tourniquet.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 20-50, PS 1& 2, Soft tissue hand and forearm surgery, Appropriate cooperation, BMI 23-28 Exclusion criteria: Addiction, History of seizures, Coagulation problem, Neuropathy, Vasculitis, Allergy to local anesthetics, Unstable hemodynamic
Intervention groups
In all three groups, the brachial plexus axillary block is performed using ultrasound and nerve stimulator. Group 1: The intercostobrachial nerve is also blocked with ultrasound guide. Group 2: The intercostobrachial nerve is blocked in conventional way without ultrasound. Group 3: The brachial plexus block is performed without the intercostobrachial nerve block.
Main outcome variables
Onset and severity of tourniquet pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170301032837N3
Registration date: 2020-05-11, 1399/02/22
Registration timing: retrospective

Last update: 2020-05-11, 1399/02/22
Update count: 0
Registration date
2020-05-11, 1399/02/22
Registrant information
Name
Behrooz Zaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 7272
Email address
zaman.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2019-06-21, 1398/03/31
Trial completion date
2019-06-21, 1398/03/31
Scientific title
The effect of ultrasound guided intercostobrachial nerve block on tourniquet pain in patients undergoing axillary block in soft arm and forearm surgery
Public title
The effect of ultrasound guided intercostobrachial nerve block on tourniquet pain in axillary block
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 - 50 Hand and forearm soft tissue surgery with a minimum operation time of 90 minutes ASA 1-2 Patients BMI between 23-28 Having the right cooperation and ability to communicate with the research team
Exclusion criteria:
Drug Addiction History of seizures Coagulation problem Upper limb neuropathy Vasculitis Unstable hemodynamic Allergy to local anesthetics
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, individual randomization using random number table, so that the first patient was drawn by drawing lots in one of the three groups and the next patient was placed in one of the other two groups by using the table of random numbers based on even and odd numbers. And this sequence continued. Only the blocking researcher knew the random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants in this study have no knowledge of the nerve block method and in which research group they belonged. The block was performed by the researcher and the evaluating researcher was not present in the room at the time of the block and another evaluates the outcomes without knowing which group the participant belongs to.Due to the fact that the intercostobrachial nerve block is performed during the axillary block, there is no apparent difference between patients after it is performed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-04-23, 1398/02/03
Ethics committee reference number
IR.IUMS.FMD.REC.1398.046

Health conditions studied

1

Description of health condition studied
Tourniquet pain in axillary block
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

Primary outcomes

1

Description
onset of pain of tourniquet
Timepoint
every 15 minutes
Method of measurement
Patient expression and Analogue Scale

2

Description
severity of tourniquet pain
Timepoint
every 15 minutes
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: ultrasound guided intercostobrachial nerve block group. In this group, after IV access and monitoring of vital signs, patients undergoing sedation with Midazolam 0.15 mg/kg and fentanyl 1.5 micrograms/kg and then is placed in a supine position with his upper extrimity 90 degree angle with the body.The axillary area and the medial part of the arm are then prepared with betadine solution and draped. Using sonography (S- Nerve Ultrasound, Sonosite, Inc. WA, USA) and nerve stimulator (Plexygon, VYGON, Inc. Italy) and needle number 21 (Locoplex, VYGON, France), at first four nerves of the median, ulna, radial, and musculoskeletal nerves are blocked, each with 7 cc of lidocaine 1.5 percent, and then the intercostobrachial nerve above the deep fascia are blocked with ultrasound and 2 cc of 1.5% lidocaine.
Category
Prevention

2

Description
Intervention group 2: intercostobrachial nerve block without ultrasound group. In this group, after IV access and monitoring of vital signs, patients undergoing sedation with Midazolam 0.15 mg/kg and fentanyl 1.5 micrograms/kg and then is placed in a supine position with his upper extrimity 90 degree angle with the body. The axillary area and the medial part of the arm are then prepared with betadine solution and draped. Using sonography (S- Nerve Ultrasound, Sonosite, Inc. WA, USA) and nerve stimulator (Plexygon, VYGON, Inc. Italy) and needle number 21 (Locoplex, VYGON, France), first four nerves of the median, ulna, radial, and musculoskeletal nerves were blocked, each with 7 cc of 1.5% lidocaine, and then the intracostobrachial nerve was blocked without ultrasound and by the conventional method, by touching the pulse of the axillary artery and injection of 2 cc of 1.5% lidocaine, on the pulse of the artery and under the skin.
Category
Prevention

3

Description
Control group: without intercostobrachial nerve block.In this group, after IV access and monitoring of vital signs, patients undergoing sedation with Midazolam 0.15 mg/kg and fentanyl 1.5 micrograms/kg and then is placed in a supine position with his upper extrimity 90 degree angle with the body. The axillary area and the medial part of the arm are then prepared with betadine solution and draped. Using sonography (S- Nerve Ultrasound, Sonosite, Inc. WA, USA) and nerve stimulator (Plexygon, VYGON, Inc. Italy) and needle number 21 (Locoplex, VYGON, France), four nerves of the median, ulna, radial, and musculoskeletal nerves are blocked, each with 7 cc of 1.5% lidocaine. The intercostobrachial nerve block is not performed in this group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat-e Fatemeh Hospital
Full name of responsible person
Dr. Noor ahmad Latifi
Street address
21st. street. Assadabadi Ave.
City
Tehran
Province
Tehran
Postal code
1433933118
Phone
+98 21 8871 7272
Fax
+98 21 8810 7658
Email
crtfatima@iums.ac.ir
Web page address
https://crtfatima.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. seyed abbas motevalian
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2030
Fax
+98 21 8862 2692
Email
ivco@iums.ac.ir
Web page address
https://iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Behrooz Zaman
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat-e fatemeh hospital, 21st street, Asadabadi Ave
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8810 7658
Email
zaman.b@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behrooz Zaman
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat-e Fatemeh Hospital, 21st Street, Asadabadi Ave.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8810 7658
Email
zaman.b@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behrooz Zaman
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat-e Fatemeh Hospital, 21st Street, Asadabadi Ave.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8810 7658
Email
zaman.b@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after people have not been identified.
When the data will become available and for how long
Start of access period from 1399
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Academic and scientific researchers can use it for future researches.
From where data/document is obtainable
zaman.b@iums.ac.ir
What processes are involved for a request to access data/document
Applicants should send the required request and explanation via e-mail to the registrant, which will be sent within a maximum of one month, if they meet the above requirements.
Comments
For academic and scientific researchers, we will provide any assistance we can.
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