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IRCT20200628047936N2 IRCT 2023-12-10 Shahid Beheshti University of Medical Sciences Comparison of two different Scalp block techniques Comparison of the Success rate between two different techniques of Scalp block: Ultrasound guided against using Landmarks 2023-12-22 anticipated 60 Complete https://irct.ir/trial/70767 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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, 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 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. N/A scalp block for craniotomy for brain mass. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For scientific purposes only Where to obtain: arashtafrishi@gmail.com Arash Tafrishinejad How to obtain: Request by email and response within 2 weeks Comments:
public Arash Tafrishinejad
Shohada hospital, Shahrdari Ave., Ghods sq.
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1174 shohada@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Arash Tafrishinejad
Shohada hospital, Shahrdari Ave., Ghods Sq.
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8000 arashtafrishi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both 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 R90.0 Intracranial space-occupying lesion found on diagnostic imaging of central nervous system Treatment - Other Treatment - Other 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. 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. The success of block. Timepoint: 10 minutes after performing block. Method of measurement: the evaluation of sensation in blocked area. Shahid Beheshti University of Medical Sciences Approved 2023-05-02 Ethics committee of Shahid Beheshty University of Medical Sciences Shahid Beheshty University of Medical Sciences, Yaman st., Velenjak Tehran Tehran Iran (Islamic Republic of)