The Efficacy of Scalp Block in Craniotomy

NCT ID: NCT06951230

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-09-01

Brief Summary

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

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.

Conditions

Post-operative Pain; Narcotics Consumption; Pain Assessment; Intraoperative Hemodynamic Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

fentanyl group

patients will receive general anesthesia followed by intravenous fentanyl (1ug/kg/hr)

Group Type: ACTIVE_COMPARATOR

Fentanyl injection

Intervention Type: DRUG

Fentanyl 1mcg/kg will be given before skin incision and Mayfield placement and followed up by fentanyl 1mcg/kg/hr, along the operation.

scalp block group

patients will receive general anesthesia followed by the scalp block.

Group Type: ACTIVE_COMPARATOR

Fentanyl injection

Intervention Type: DRUG

Fentanyl 1mcg/kg will be given before skin incision and Mayfield placement and followed up by fentanyl 1mcg/kg/hr, along the operation.

scalp block

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hegazy

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FMASU MS72/2024

Identifier Type: -

Identifier Source: org_study_id