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

NCT07411274 | Not Yet Recruiting Phase 3

• 1 other identifier: MD-403-2025
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Duration of analgesia

  24 hours postoperatively

• objective pain scale

  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

Study Arms (2)

Ultrasound-guided scalp block using bupivacaine

ACTIVE COMPARATOR

patients will recieve ultrasound-guided scalp block using bupivacaine

Procedure: Ultrasound-guided scalp block

conventional scalp block using bupivacaine

ACTIVE COMPARATOR

patients will recieve conventional scalp block with bupivacaine using a landmark-based technique

Procedure: conventional scalp block

Interventions

Ultrasound-guided scalp block PROCEDURE

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.

Ultrasound-guided scalp block using bupivacaine

conventional scalp block PROCEDURE

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.

conventional scalp block using bupivacaine

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anaesthesia

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01