Ultrasound-Guided vs. Conventional Scalp Block for Postoperative Analgesia in Pediatric Supratentorial Tumor Surgeries

Comparison of Ultrasound-Guided vs. Conventional Scalp Block for Postoperative Analgesia in Pediatric Supratentorial Tumor Surgeries: A Randomized Controlled Trial.

Although scalp nerve blocks have been shown to provide effective postoperative analgesia in pediatric neurosurgical procedures, limited data exist on their use under ultrasound guidance. The smaller anatomical structures and higher vascularity of the pediatric scalp increase the risk of inadvertent vessel puncture or systemic toxicity with landmark-based techniques. Ultrasound guidance enables direct visualization of the targeted nerves and adjacent vessels, potentially improving block accuracy and safety. To date, no randomized controlled trial has compared ultrasound-guided versus conventional scalp block specifically in pediatric supratentorial tumor surgeries. This study aims to fill this gap.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Postoperative
• Intervention / Treatment: Procedure: Ultrasound-guided scalp block; Procedure: conventional scalp block

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I, II.
• Undergoing elective supratentorial tumor surgery under general anesthesia on one side of the head.

Exclusion Criteria:

• Urgent/emergency craniotomy.
• Coagulopathy or platelet dysfunction.
• Allergy to local anesthetics.
• Pre-existing bradycardia (HR <60 bpm in infants, <50 bpm in older children) or unstable arrhythmias.
• Severe hepatic/renal impairment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound-guided scalp block using bupivacaine; patients will recieve ultrasound-guided scalp block using bupivacaine	Procedure: Ultrasound-guided scalp block; Patients will receive ultrasound-guided scalp block using bupivacaine 0.25% at 0.1-0.2 mL/kg per nerve site, not exceeding a total dose of 2.5 mg/kg.
Active Comparator: conventional scalp block using bupivacaine; patients will recieve conventional scalp block with bupivacaine using a landmark-based technique	Procedure: conventional scalp block; Patients will receive conventional scalp block using landmark-based technique with bupivacaine 0.25% at 0.1-0.2 mL/kg per nerve site, not exceeding a total dose of 2.5 mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial blood pressure intraoperatively from baseline till skin incision	The mean arterial blood pressure recorded during 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after incision	from 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after incision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	The time to the first postoperative analgesic request	24 hours postoperatively
objective pain scale	objective pain scale is based on 5 criteria: (1) systolic arterial blood pressure, (2) crying, (3) movement, (4) agitation, and (5) verbal evaluation (complaint of pain). Each criterion is allocated a score of 0 to 2 (2 being the worst), giving a minimum OPS score of 0 and the maximum possible score of 10; the worst OPS score is 10 if the child is old enough to complain of pain and 8 if the child is too young to complain of pain	2, 4, 6, 8, 12, 16, and 24 hours postoperatively
Total doses of ketorolac		24 hours postoperatively
6. Total dose of paracetamol		24 hours postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: MD-403-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No