Supra Inguinal Fascia Iliaca Block Versus Ultrasound-guided Caudal Analgesia for Pediatrics Undergoing Anterior and Lateral Thigh Surgeries: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fascia Iliaca Nerve Block, Caudal Block Anesthesia.
- Who it may be relevant to
- Registry conditions: Cancer Bone. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- • Estimation of time of first rescue postoperative analgesia [Time frame: 4 hours postoperatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- National Cancer institute — Cairo
Identifiers
NCT: NCT07056946 · AP2502-501-098-195