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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.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07411274
Enrollment
74
Registered
2026-02-13
Start date
2026-02-01
Completion date
2026-10-01
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Postoperative

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.

Interventions

PROCEDUREUltrasound-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.

PROCEDUREconventional 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean arterial blood pressure intraoperatively from baseline till skin incisionfrom 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after incisionThe 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

MeasureTime frameDescription
Duration of analgesia24 hours postoperativelyThe time to the first postoperative analgesic request
objective pain scale2, 4, 6, 8, 12, 16, and 24 hours postoperativelyobjective 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
Total doses of ketorolac24 hours postoperatively
6. Total dose of paracetamol24 hours postoperatively

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026