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Not yet recruiting NCT07411274

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

Phase III Interventional Pain Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-guided scalp block, conventional scalp block.
Who it may be relevant to
Registry conditions: Pain Postoperative. Basic parameters: 2 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Duration of analgesia [Time frame: 24 hours postoperatively]
  • objective pain scale [Time frame: 2, 4, 6, 8, 12, 16, and 24 hours postoperatively]
  • Total doses of ketorolac [Time frame: 24 hours postoperatively]
  • 6. Total dose of paracetamol [Time frame: 24 hours postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07411274 · MD-403-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗