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临床试验/NCT07056946
NCT07056946已完成不适用

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

National Cancer Institute, Egypt2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
• Estimation of time of first rescue postoperative analgesia

研究概览

简要总结

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.

详细描述

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 0.125% 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 1-7 years
  • scheduled for anterior and lateral thigh Surgeries
  • American Society of Anesthesiologists (ASA) physical status II or III

排除标准

  • Refusal of parental consent
  • Allergy to any local anesthetics

研究组 & 干预措施

Group C: in this group children will receive US-guided caudal analgesia (CA) after GA.

Active Comparator

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

干预措施: Caudal Block Anesthesia (Other)

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

Experimental

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

干预措施: Fascia Iliaca Nerve Block (Other)

结局指标

主要结局

• Estimation of time of first rescue postoperative analgesia

时间窗: 4 hours postoperatively

次要结局

未报告次要终点

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzan Adlan Abdelrahman

assistant professor

National Cancer Institute, Egypt

研究点 (2)

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