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

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.

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Key information

Conditions

Cancer Bone Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer institute, Cairo, Cairo Governorate, Egypt

About this study

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).

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.
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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age 1-12 years
scheduled for anterior and lateral thigh Surgeries
American Society of Anesthesiologists (ASA) physical status II or III

Exclusion criteria

Refusal of parental consent
Allergy to any local anesthetics

Treatment and study plan

Fascia Iliaca Nerve Block

Other

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

Caudal Block Anesthesia

Other

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

Primary outcomes

• Estimation of time of first rescue postoperative analgesia

Time frame: 4 hours postoperatively

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 9, 2025
Registry last updated: Aug 14, 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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Completed