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NCT Number: NCT07411274

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

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.

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Key information

Conditions

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

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean arterial blood pressure intraoperatively from baseline till skin incision

    Time frame: from 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after 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

Secondary outcomes

  1. Duration of analgesia

    Time frame: 24 hours postoperatively

    The time to the first postoperative analgesic request

  2. objective pain scale

    Time frame: 2, 4, 6, 8, 12, 16, and 24 hours postoperatively

    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

  3. Total doses of ketorolac

    Time frame: 24 hours postoperatively

  4. 6. Total dose of paracetamol

    Time frame: 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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