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The aim of the study is to compare the effectiveness and safety of scalp block versus intravenous fentanyl in pain control intraoperatively in craniotomy patients. Most of the previous studies compared the effect of scalp block versus fentanyl or opioids in postoperative pain
The history will be obtained from patient. The patients fasting 8 hours preoperatively will be examined and assessed, especially neurologically, to exclude any neurological deficit that may affect the results. Pre-operative laboratories will be reviewed for all patients as (complete blood picture, renal function tests, liver function tests, and coagulation profile) .
Patients will be assigned randomly by using a computer -generated table of random numbers, placing them in sealed envelopes, into two groups:
Pre-oxygenation with 100% oxygen will last 3 minutes, followed by IV induction with Propofol (2 mg/kg), Atracurium (0.5 mg/kg), and Fentanyl (1 mcg/kg). The patient will be placed on inhaled Isoflurane, and smooth intubation will be performed. Invasive blood pressure monitoring will be set up via the non-dominant radial artery, and a central venous line will be inserted in the internal jugular vein using ultrasound.
A scalp block will be done blindly for group B, while group A will receive Fentanyl (1 mcg/kg/hr) prior to Mayfield placement and skin incision. Throughout the operation, continuous monitoring of Electrocardiogram, Heart rate, invasive blood pressure (IBP), oxygen saturation and urine output will occur.
The scalp block will be performed under aseptic conditions by qualified personnel, with the patient in the supine position, using a landmark technique to target the relevant nerves for the blockage in group A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fentanyl group | Active Comparator | patients will receive general anesthesia followed by intravenous fentanyl (1ug/kg/hr) |
|
| scalp block group | Active Comparator | patients will receive general anesthesia followed by the scalp block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl injection | Drug | Fentanyl 1mcg/kg will be given before skin incision and Mayfield placement and followed up by fentanyl 1mcg/kg/hr, along the operation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| intra-operative hemodynamic stability | Recording the mean arterial blood pressure and heart rate readings will be obtained before induction , on skin pinning, on skin incision , 1 hour post induction, after 2hours and every hour hour till the end of the surgery | intra-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| fentanyl consumption | The total amount of fentanyl required along the operation will be recorded to detect the effect of the scalp block on narcotic consumption. | intra-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| post-operative pain | The pain is assessed post operatively in all patients 1 hour post-operatively using visual analogue scale a scale from 0 to 10 , where 0 is no pain and 10 is the worst unbearable pain. the amount of opiods needed will be recorded to detect the effect of the scalp block on postoperative pain control and decreasing narcotic demand. | 1 hour post-operatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hegazy | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Cairo Governorate | 11111 | Egypt |
All dana will be shared once study is completed
before 6/2025
free
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| scalp block | Procedure | The scalp block procedure is performed with the patient in the supine position, utilizing surface landmarks for guidance. The local anesthetic is injected into the nerves after careful aspiration and under strict aseptic technique. The nerves that are typically injected include the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, as well as the lesser and greater occipital nerves, with or without the inclusion of the third occipital nerve. The volume of 0.5% bupivacaine injected should not exceed 2 ml at each site. |
|
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |