Comparison of scalp nerve block success rate between two landmark and ultrasound guided methods
Design
The study is a randomized clinical trial with two parallel groups of landmark and ultrasound and double-blinded with 60 samples. Randomization will be done with the help of Sealed envelope 2022 software and generating random sequences in the form of variable blocks (2,4 and 6) and the person who records the results and the statistical analyzer will be blind to the groups. In the first group, nerves will be identified using landmarks, and in the second group, nerve localization will be done under ultrasound guidance. The success of each injection will be checked by another anesthesiologist who is blind to the patient group. In addition, any unwanted complications will be monitored and recorded up to 12 hours after the nerve block. Finally, the data will be analyzed by a statistical analyst who is unaware of the sample group and the results will be reported.
Settings and conduct
In Shohada Tajrish Hospital in Tehran, the success rate of scalp block with two different techniques will be compared in craniotomy patients randomly divided into two groups, the anesthesiologist who checks the success of block and the data analyzer will be blind to samples group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients aged 18-70 who are candidates for elective craniotomy, no history of chronic disease .Exclusion criteria:lack of patients cooperation.
Intervention groups
Patients will be divided into two groups of 30 people (landmark group and ultrasound group). Both groups of patients will undergo scalp nerve block before induction of anesthesia. In the first group, the nerves identified using landmarks and in the second group, drug injection will be done under ultrasound guidance.
Main outcome variables
Block success,Amount of drug used,Occurrence of complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200628047936N2
Registration date:2023-12-10, 1402/09/19
Registration timing:prospective
Last update:2023-12-10, 1402/09/19
Update count:0
Registration date
2023-12-10, 1402/09/19
Registrant information
Name
Arash Tafrishinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 4715
Email address
arashtafrishi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-18, 1402/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Success rate between two different techniques of Scalp block: Ultrasound guided against using Landmarks
Public title
Comparison of two different Scalp block techniques
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient who is a candidate for craniotomy surgery
age between 18-70
No diabetes and neuropathy
No drug addiction
Consciousness and complete wakefulness
Not having clinical symptoms of increased intracerebral pressure (nausea, headache, diplopia)
No history of sensitivity to local anesthetic
Exclusion criteria:
Lack of proper cooperation in evaluating the success of the block
The presence of infection or cellulitis in the target area of the block
Lack of proper cooperation during block
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
12
For a complete block of sensation in the scalp area, 6 known nerves on each side of the skull are subjected to local anesthetic injection, which includes a total of 12 injections and blocks per person.
Randomization (investigator's opinion)
Randomized
Randomization description
In order to create a random sequence, randomization will be done with the method of variable blocks . A random sequence of 60 samples will be created in blocks of 2, 4, and 6 using online web based software (www.sealdenvelope.com), and the samples will be assigned to ultrasound and landmark groups based on the sequence created by the software and the order of patients' enrolling to study. The number of samples allocated to groups in each block will be equal. (Sealed Envelope Ltd. 2022)
Blinding (investigator's opinion)
Double blinded
Blinding description
After dividing the patients into two groups and performing the block by the anesthesiologist, after ten minutes the success of the block will be evaluated by another researcher who is unaware of the patient's group. In addition, the statistical analyzer will be unaware of the group of patients.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, 60 patients who are candidates for craniotomy and are eligible to enter the study will be randomly divided into two groups of 30 people. The first group will undergo a scalp block using landmarks and the second group will undergo an ultrasound-guided scalp block before induction of anesthesia. 10 minutes after the injection, the success of each nerve block will be evaluated and recorded in the designed questionnaire. In addition, any possible complications will be registered and finally the results will be subjected to statistical analysis and reported. The researcher who checks the Block success and statistical analyzer will be blind to the groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshty University of Medical Sciences
Street address
Shahid Beheshty University of Medical Sciences, Yaman st., Velenjak
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR.SBMU.MSP.REC.1402.012
Health conditions studied
1
Description of health condition studied
scalp block for craniotomy for brain mass
ICD-10 code
R90.0
ICD-10 code description
Intracranial space-occupying lesion found on diagnostic imaging of central nervous system
Primary outcomes
1
Description
the success of block
Timepoint
10 minutes after performing block
Method of measurement
the evaluation of sensation in blocked area
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the ultrasound group, in order to perform sculp block ,the localization of the cranial nerves is performed by known methods under the guidance of the ultrasound .In this group, all the nerves related to the scalp block (12 nerves) will be identified by ultrasound and they will be injected with 0.5% ropivacaine (Molteni ,Italia) using a 29G needle under ultrasound guidance.
Category
Treatment - Other
2
Description
Control group: In this group, in order to perform sculp block, the localization of the cranial nerves is done according to the usual methods and using the anatomy of the skull and face. In this group, all the nerves related to the scalp block (12 nerves) will be injected with 0.5% ropivacaine (Molteni ,Italia) using a 29G size needle.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Arash Tafrishinejad
Street address
Shahrdari Ave., Ghods Sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Tafrishinejad
Street address
Yaman st., Velenjak
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Tafrishinejad
Position
Assistant Profedssor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada hospital, Shahrdari Ave., Ghods sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1174
Email
shohada@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Tafrishinejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada hospital, Shahrdari Ave., Ghods Sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
arashtafrishi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Tafrishinejad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada hospital, Shahrdari Ave., Ghods Sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
arashtafrishi@gmail.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For scientific purposes only
From where data/document is obtainable
arashtafrishi@gmail.com
Arash Tafrishinejad
What processes are involved for a request to access data/document