Comparison of Ultrasound-Guided vs. Conventional Scalp Block for Postoperative Analgesia in Pediatric Supratentorial Tumor Surgeries: A Randomized Controlled Trial.
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 74
- Primary Endpoint
- Mean arterial blood pressure intraoperatively from baseline till skin incision
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Ultrasound-guided scalp block using bupivacaine
patients will recieve ultrasound-guided scalp block using bupivacaine
Intervention: Ultrasound-guided scalp block (Procedure)
conventional scalp block using bupivacaine
patients will recieve conventional scalp block with bupivacaine using a landmark-based technique
Intervention: conventional scalp block (Procedure)
Outcomes
Primary Outcomes
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
- 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)
Investigators
AbdElKhalik Mahmoud Shaban
Lecturer of anaesthesia
Cairo University