NCT07056946

Supra Inguinal Fascia Iliaca Block Versus Ultrasound-guided Caudal Analgesia for Pediatrics Undergoing Anterior and Lateral Thigh Surgeries: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

patients will then be randomized in the two groups. 1. Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. The caudal block will be performed 2. Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US-guided fascia iliaca Block.

Detailed description

After assessment of eligibility criteria, a clinical nurse independent of the protocol will obtain the randomization number and patients will then be randomized in the two groups. Treatment allocation will follow the order of a predetermined randomization list and will be generated using random blocks. Randomized will be done through computer program with patient blinded to the type of intervention (single blinded). 1. Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. The caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornu after placing the probe transversely obtaining a short axis view, two hyperechoic lines will appear between the sacral cornu the superficial line is the sacrococcygeal ligament which will be pierced by the needle 22-gauge echogenic non-stimulating 5-cm needle (Ultraplex; B. Braun Medical Bethlehem PA, USA) using the out-of-plane approach. After confirming the absence of any blood or cerebrospinal fluid in the aspiration the caudal mixture (1 mL/kg of 0.25% bupivacaine a maximum volume of 20 mL will be used) will be injected. 2. Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US-guided fascia iliaca Block. American Society of Anesthiologists recommends monitors, intravenous line, and O2 (3 L/min) through the nasal cannula will be used. All blocks will be executed under the guidance of a 5-13 MHz linear ultrasound probe covered in a sterile sheath and attached to a Sonosite (M- Turbo; SonoSite Inc. Bothell WA USA) portable ultrasound machine. Preoperatively the maximum dose of bupivacaine will be calculated (2 mg/kg) so as not to exceed the dose during injection in either group.

Conditions

• Cancer Bone

Interventions

Type	Name	Description
OTHER	Fascia Iliaca Nerve Block	With the patient in the proper position, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. After a skin wheal is made, the needle is inserted in-plane
OTHER	Caudal Block Anesthesia	The caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornu after placing the probe transversely obtaining a short axis view, two hyperechoic lines will appear between the sacral cornu the superficial line is the sacrococcygeal ligament

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-07-09
• Last updated: 2025-07-15

Locations

1 site across 1 country: Egypt