Scalp Nerve Block and Opioid Consumption in Brain Surgery

Study Overview
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Brief Summary
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Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

Detailed Description
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Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo). A Prospective Randomized Double Blind Control

Official Title
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The Effect of Pre-incisional Anterior Scalp Block on Intraoperative Opioid Consumption in Adult Patients Undergoing Elective Craniotomy to Remove Tumor: A Prospective Randomized Controlled

Conditions
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Brain Tumour

Intervention / Treatment
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* Drug: Scalp block with 0.5% plain Marcaine
* Drug: Scalp block with 0.9% normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have supratentorial brain tumor Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position Patients have been general anesthetized with endotracheal intubation and control ventilation Patients who have provided consent for the participation in the research and for the use of their medical record in research Exclusion Criteria: Pregnant patients Patients who have a history of local anesthetic allergy and/ or anaphylaxis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scalp block with 0.5% plain marcaine<br>Anterior scalp block with 0.5% plain Marcaine 20 ml. | Drug: Scalp block with 0.5% plain Marcaine<br>* Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.<br>* Other names: Code 1;|
| Placebo Comparator: Scalp block with 0.9% normal saline<br>Anterior scalp block with 0.9% normal saline 20 ml. | Drug: Scalp block with 0.9% normal saline<br>* Anterior scalp block will be done by using 0.9% normal saline 20 ml.<br>* Other names: Code 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative opioid consumption | The overall intravenous fentanyl consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level. | During the supratentorial craniotomy surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure change | The maximal systolic blood pressure within the first 5 minutes after skull pin insertion will be recorded. The systolic blood pressure change from baseline will be calculated. The unit is mmHg. | within 5 minutes after skull pin insertion | 
| Heart rate change | The maximal heart rate within the first 5 minutes after skull pin insertion will be recorded. The heart rate change from baseline level will be calculated. The unit is beats per minute. | within 5 minutes after skull pin insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supratentorial brain tumour, craniotomy