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

NCT ID: NCT07056946

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-07-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Caudal Block Anesthesia

Intervention Type: 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

Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US

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

Group Type: EXPERIMENTAL

Fascia Iliaca Nerve Block

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Suzan Adlan Abdelrahman

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer institute

Cairo, , Egypt

Countries

Egypt

Central Contacts

suzan Adlan Adlan, MD

Role: CONTACT

dr_s.adlan@hotmail.com

+201111068300

Facility Contacts

suzan Adlan Adlan

Role: primary

dr_s.adlan@hotmail.com

01111068300

Other Identifiers

AP2502-501-098-195

Identifier Type: -

Identifier Source: org_study_id