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Comparison of the success rate of axillary network block with 0.25% bupivacaine injection with or without dexamethasone, under ultrasound guide in upper limb trauma surgeries

Protocol summary

Study aim
Comparison of the success rate of axillary network block with 0.25% bupivacaine injection with or without dexamethasone under ultrasound guide in upper limb trauma surgery
Design
A double-blinded, randomized clinical trial with parallel groups design of 72 patients
Settings and conduct
This study is a clinical trial in poursina hospital in Rasht. Patients who are candidates for elective forearm surgery will be in one of the two groups, using the randomized blocks method. All nerve blocks (brachial axillary network) will be performed by the anesthesiologist in charge, using the M7 model ultrasound device with a 10 megahertz transformer (linear probe). The patient will be in the supine position while the shoulder is abducted and the elbow in the same hand is flexed. Using the nerve block needle No. 22, with a length of 5 centimeters, Arrow model, and in-plane technique, we enter from the lateral to the medial. Then the drugs will be injected into the nerve of the musculoskeletal, median, radial, and ulnar nerves. This study is double-blinded, patients and the evaluator and surgeon are blind and the anesthesiologist in charge is aware of the treatment groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with upper limb trauma, candidates for elective upper limb surgery, Age over 18 years, ASA class I-III Exclusion criteria: Diabetes, Drug addiction, Sepsis, Infection of the injection site, Sensitivity to local anesthetics, Coagulation disorder, Kidney or liver failure.
Intervention groups
Intervention group: Axillary network block with 30 milliliters of 0.25% bupivacaine plus 2 milliliters of dexamethasone (8 milligrams) Control group: Axillary network block with 30 milliliters of bupivacaine 0.25% in addition to 2 milliliters of Sterile water
Main outcome variables
The intensity of sensory and motor blocks

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011766N7
Registration date: 2021-06-21, 1400/03/31
Registration timing: registered_while_recruiting

Last update: 2021-06-21, 1400/03/31
Update count: 0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
Hossein Khoshrang
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 0028
Email address
khoshrang@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success rate of axillary network block with 0.25% bupivacaine injection with or without dexamethasone, under ultrasound guide in upper limb trauma surgeries
Public title
Axillary network block under ultrasound guide in upper limb trauma surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with upper limb trauma, candidates for elective upper limb surgery Age over 18 years ASA class I-III
Exclusion criteria:
Diabetes Drug addiction Sepsis Infection of injection site Sensitivity to local anesthetics Coagulation disorder Kidney or liver failure History of previous weakness and paresis in the operation area History of axillary surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible individuals will be divided into intervention and control groups using block randomization method with 4 and 6 block sizes. To generate a randomization list from the online randomization service Sealed Envelope Ltd. 2019 was used (https://www.sealedenvelope.com/simple-randomiser/v1/lists.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and the researcher collecting information will not be informed about the type of therapy received for each group in a double-blind manner, and each of the two types of treatment will be sent to therapists in a sealed envelope.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht
City
Rasht
Province
Guilan
Postal code
4144654839
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.GUMS.REC.1399.650

Health conditions studied

1

Description of health condition studied
Control of acute pain after upper limb surgery
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma

Primary outcomes

1

Description
Intensity of sensory block
Timepoint
After the anesthesia procedure, every 5 minutes along 30 minutes
Method of measurement
According to the Pinprick test: zero has a perfect sense, one a slight sense, two have no sense at all

2

Description
Intensity of motor block
Timepoint
After the anesthesia procedure, every 5 minutes along 30 minutes
Method of measurement
According to the Modified Bromage Scale: zero inability to move fingers, one only being able to move fingers, two being able to move and bend the wrist, three full elbow flexions.

Secondary outcomes

1

Description
Possible side effects of injecting medication
Timepoint
During the procedure till the end of the surgery
Method of measurement
Checking of of paraesthesia, incorrect intravascular injection, hematoma and nerve damage

Intervention groups

1

Description
Intervention group: group of Bupivacaine injection 0.25% with dexamethasone: All nerve blocks (brachial axillary network) will be performed by the anesthesiologist in charge, using the M7 model ultrasound device with a 10 megahertz transformer (linear probe). Oxygen will be prescribed for all patients 6 Litre per minute with the mask. standard monitoring (pulse oximetry, ECG, and Blood pressure) will be performed. The patient will be in the supine position while the shoulder is abducted and the elbow in the same hand is flexed. With sterility, under direct ultrasound vision, while the linear probe is located as a short axis in the axillary region, the musculocutaneous nerve and the axillary artery will be seen. Then, using the nerve block needle No. 22, with a length of 5 centimeters, Arrow model, and in-plane technique, we enter from the lateral to the medial. First, 30 milliliters of 0.25% bupivacaine plus 2 milliliters of dexamethasone (8 milligrams) will be injected into the nerve of the musculoskeletal nerve and then into the median, radial, and ulnar nerves. After ensuring the patients' analgesia, the orthopedist will be allowed to perform the surgery. Midazolam 0.02 milligrams per kilogram is prescribed to all patients for sedation before the blockade. Fentanyl 0.5 macrogramms per kilograms is also given to prevent tourniquet pain.
Category
Treatment - Drugs

2

Description
Control group: Injection group of bupivacaine 0.25% without dexamethasone: All nerve blocks (brachial axillary network) will be performed by the anesthesiologist in charge, using the M7 model ultrasound device with a 10 megahertz transformer (linear probe). Oxygen will be prescribed for all patients 6 Litre per minute with the mask. standard monitoring (pulse oximetry, ECG, and Blood pressure) will be performed. The patient will be in the supine position while the shoulder is abducted and the elbow in the same hand is flexed. With sterility, under direct ultrasound vision, while the linear probe is located as a short axis in the axillary region, the musculocutaneous nerve and the axillary artery will be seen. Then, using the nerve block needle No. 22, with a length of 5 centimeters, Arrow model, and in-plane technique, we enter from the lateral to the medial. First, 30 milliliters of 0.25% bupivacaine plus 2 milliliters of Sterile water will be injected into the nerve of the musculoskeletal nerve and then into the median, radial, and ulnar nerves. After ensuring the patients' analgesia, the orthopedist will be allowed to perform the surgery. Midazolam 0.02 milligrams per kilogram is prescribed to all patients for sedation before the blockade. Fentanyl 0.5 macrogramms per kilograms is also given to prevent tourniquet pain.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Dr Hossein Khoshrang
Street address
Poursina Hospital، Poursina Xrd, Hafez St, Rasht
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3332 2444
Email
poursina@gums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Naghipoor
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht
City
Rasht
Province
Guilan
Postal code
6694941446
Phone
+98 13 3333 5821
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice President of Research Guilan 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
Anesthesiology Research Center
Full name of responsible person
Hossein Khoshrang
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Razi Hospital
City
Rasht
Province
Guilan
Postal code
4139638459
Phone
+98 13 3336 8534
Fax
+98 13 3336 8651
Email
arcguilan1392@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Anesthesiology Research Center
Full name of responsible person
Hossein Khoshrang
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Razi Hospital
City
Rasht
Province
Guilan
Postal code
4139638459
Phone
+98 13 3336 8534
Fax
+98 13 3336 8651
Email
arcguilan1392@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohadese Ahmadi
Position
Senior Expert of Research Affairs/MSc in Teaching English as a foreign language
Latest degree
Master
Other areas of specialty/work
Senior Expert of Research Affairs
Street address
Anestesiology Reseaech Center, Alzahra Hospital, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9328
Email
p.ahmadi2311@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
Undecided - It is not yet known if there will be a plan to make this available
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
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