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临床试验/NCT07137962
NCT07137962已完成不适用

Comparison Between Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block Versus Caudal Block for Postoperative Analgesia in Hip Surgeries in Children, A Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Total opioid consumption

研究概览

简要总结

The study aims to compare the effect of pericapsular nerve group block versus fascia iliaca compartment block versus caudal block regarding Postoperative analgesia in children undergoing hip surgeries.

详细描述

Study included ASA I, II,1-6 years old from both sexes, scheduled for elective hip surgery.while exclusion criteria include ASA III and IV, Allergy to any medication used, neurological or psychological disorders, anatomic abnormalities or infection at site of injection and bleeding disorders (international normalized ratio (INR) >1.5 and/or platelet count <100,000/µL).

Computer-generated randomization numbers were used for random allocation and each patients' code was kept in an opaque sealed envelope. Patients were randomly allocated with 1:1:1 allocation ratio into three groups in a parallel manner:

Group A: patients received pericapsular nerve block group (PENG) block with 0.25% bupivacaine 0.5 ml/kg.

Group B: patients received fascia iliaca compartment block (FICB) with 0.25% bupivacaine 0.5 ml/kg.

Group C: patients received caudal block with 0.25% bupivacaine 1 ml/kg. On the day before the surgery, pre-operative assessment was performed, Medical and surgical history were taken, examination (airway to exclude difficult airway, chest, back, abdomen, and limbs to exclude infection at injection site and anatomical deformities) was performed.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Computer-generated randomization numbers were used for random allocation and each patients' code was kept in an opaque sealed envelope. Patients were randomly allocated with 1:1:1 allocation ratio into three groups in a parallel manner.

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •ASA I, II,1-6 years old from both sexes, scheduled for elective hip surgery.

排除标准

  • •ASA III and IV, Allergy to any medication used, neurological or psychological disorders, anatomic abnormalities or infection at site of injection and bleeding disorders (international normalized ratio (INR) >1.5 and/or platelet count <100,000/µL).

研究组 & 干预措施

Group A: PENG Block

Active Comparator

The curvilinear low-frequency (2-5 MHz) ultrasound probe was placed over the line parallel to the inguinal ligament. It was subsequently rotated 45° to identify the anterior inferior iliac spine, the ilio-pubic eminence, and the psoas tendon. A needle was inserted in the plane to place the tip in the musculo-fascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly, using the hydro-dissection technique. Following negative aspiration, a total volume of 0.5 ml/kg of 0.25% bupivacaine was injected.

干预措施: PENG Block (Procedure)

Group B: FICB block

Active Comparator

The linear ultrasound probe was placed over the inguinal ligament in the sagittal plane, inferomedial to the anterior superior iliac spine. Upon identifying the "bow-tie sign" formed by the sartorius muscle and the internal oblique muscle by sliding medially and rotating the probe. 22-gauge echogenic needle was introduced 1 cm cephalad to the inguinal ligament to place the needle tip in the space between the internal oblique and iliacus muscles, using the hydro-dissection technique. A total volume of 0.5 mL/kg of bupivacaine 0.25% was injected following negative aspiration.

干预措施: FICB Block (Procedure)

Group C:Caudal Block

Active Comparator

The patient was placed in the left lateral position with the upper hip flexed at 90° and the lower hip flexed at 45°. The region was then swabbed in a craniocaudal direction with 70% alcohol. After palpating the landmarks (the upper posterior iliac spine and sacral hiatus from the edges of an equilateral triangle), an epidural puncture was performed in the most proximal region of the sacral hiatus with the needle inclined 45-60° to the skin. While palpating with the index finger of the left hand, a needle was inserted immediately below the spinous process S4. After perforating the membrane, which occludes the sacral hiatus, the needle was advanced no more than 1-3 mm to avoid a bloody puncture or an intrathecal injection. Bupivacaine 0.25% at a dose of 1 ml/kg was injected, with care taken to not exceed the maximum recommended dose (2 mg/kg).

干预措施: Caudal Block (Procedure)

结局指标

主要结局

Total opioid consumption

时间窗: The first 24 hours postoperative.

Total opioid (morphine) (mg) consumption in the first 24 hours postoperative.

次要结局

  • FLACC Pain Scale(24 hours)
  • Time for first rescue analgesia(24 hours)
  • Total opioid consumption(time of operation up to 6 hours)
  • Postoperative nausea and vomiting(24 hours)
  • Incidence of complications(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nagy Malak , MD

Lecturer of anesthesia ,SICU and pain

Cairo University

研究点 (1)

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