The Efficacy of Scalp Block in Craniotomy

The Efficacy of Scalp Block Versus Intravenous Fentanyl in Pain Control Intraoperatively in Craniotomy Patients

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

Study Overview

• Status: Completed
• Conditions: Post-operative Pain; Pain Assessment; Narcotics Consumption; Intraoperative Hemodynamic Instability
• Intervention / Treatment: Drug: Fentanyl injection; Procedure: scalp block

Detailed Description

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:

• Group A: (n= 10): patients will receive general anesthesia followed by intravenous fentanyl (1ug/kg/hr)
• Group B (control group): (n= 10): patients will receive general anesthesia then receive scalp block In the operating room, the monitor will be connected to track pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and heart rate (HR). A second recording will occur after induction. An IV cannula will be inserted, and an electrocardiogram (ECG) obtained.

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11111
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 20 and 60
• Physical status: ASA I and II
• Elective operation, under general anaesthesia,

Exclusion Criteria:

• ASA above ll
• Patients with known uncontrolled comorbidities such as hypertension or Diabetes Mellites
• Coagulopathy, use of anti-coagulant or anti-platelet therapy.
• Known allergies to drugs used (Bupivacaine)
• Infection at the site of injection
• History of cranial nerve affection
• Emergency craniotomy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fentanyl group; patients will receive general anesthesia followed by intravenous fentanyl (1ug/kg/hr)	Drug: Fentanyl injection; Fentanyl 1mcg/kg will be given before skin incision and Mayfield placement and followed up by fentanyl 1mcg/kg/hr, along the operation.
Active Comparator: scalp block group; patients will receive general anesthesia followed by the scalp block.	Drug: Fentanyl injection; Fentanyl 1mcg/kg will be given before skin incision and Mayfield placement and followed up by fentanyl 1mcg/kg/hr, along the operation.; Procedure: scalp block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Hegazy, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: pain; craniotomy; Pain control; scalp block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Fentanyl
• Other Study ID Numbers: FMASU MS72/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All dana will be shared once study is completed
• IPD Sharing Time Frame: before 6/2025
• IPD Sharing Access Criteria: free
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No