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临床试验/NCT03646630
NCT03646630已完成不适用

Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block for Pain Relief in Children Undergoing Lower Abdominal Surgeries

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年5月2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
52
试验地点
1
主要终点
Time at which the first analgesia required

研究概览

简要总结

The aim of this study is to compare between two regional analgesic techniques; caudal block and ultrasound guided quadratus lumborum block as regard degree of pain relief, accuracy of block, effect on hemodynamic stability and incidence of complications.

详细描述

Regional anesthesia and analgesia techniques are commonly used during pediatric surgical practice to facilitate pain control, decrease parenteral opioid requirements and improve the quality of post-operative pain control and patient-parent satisfaction. The most commonly used technique is caudal anesthesia, which is generally indicated for urologic surgery, inguinal hernia repair and lower extremity surgery. The quadratus lumborum (QL) block is a recently introduced abdominal truncal block, used for somatic and visceral analgesia of both the upper and lower abdomen. It was first described by Blanco in 2007 . Currently, the QL block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery . QL block allows the local anesthetics to spread between the posterior aspect of the quadratus lumborum muscle and the medial layer of the thoracolumbar fascia, which is close to the thoracic paravertebral space .

The ultrasound (US) has gained popularity among anesthesiologists performing regional anesthesia. Block success, and hence the efficacy would depend on the patient's anatomical variations and the anesthesiologist's skill level .

The use of ultrasound-guidance for peripheral nerve blocks (PNBs) offers many advantages. Direct visualization of the nervous and surrounding structures decreases the incidence of complications e.g. inadvertent intraneural or intravascular injection. Direct real-time observation of the local anesthetics spread ensures more accurate deposition .This leads to faster onset and longer duration of block, thus improves block quality. It also allows dose reduction of local anesthetics . It has been shown that when peripheral nerves are adequately imaged by ultrasound, the simultaneous use of the nerve stimulator offers no further advantages.

Following ethical committee approval of Anesthesia department, Fayoum University and obtaining informed consent from parents of each patient, fifty two patients will be randomized into 2 study groups. Each group contains 26 patients.

Methodology:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Age 1-7 years
  • •American Society of Anesthesiologists physical status I-II
  • •Lower abdominal surgery

排除标准

  • •History of developmental delay or mental retardation
  • •Parent refusal
  • •History of allergic reactions to local anesthetics
  • •Rash or infection at the injection site
  • •Anatomical abnormality
  • •Bleeding disorders.
  • •History of cardiac, neurological, renal, hepatic diseases.

研究组 & 干预措施

Quadratus Lumborum Block (QL)

Active Comparator

Patients will be placed in the lateral position,The high-frequency linear probe will be placed on the lateral abdomen, slightly cephalic to the iliac crest. Once the QL muscle will be observed, the probe will be tilted slightly to the caudal direction, to show the largest slice of the QL muscle, to confirm its posterior aspect. A 22-G block needle (Stimuplex D, Braun, Hongo, Bunkyo-ku, and Tokyo) will be inserted in-plane, ~1 cm ventral to the probe. The needle tip will be advanced until it penetrates the posterior fascia of the QL muscle. A small amount of saline will be injected to confirm the correct position of the tip, between the QL muscle and the erector spinae and latissimus dorsi muscles (Posterior or QL block type 2), then a bolus of 0.5 ml/Kg bupivacaine 0.25% will be injected.

干预措施: Quadratus Lumborum Block (Procedure)

Caudal block (C)

Active Comparator

After induction of general anesthesia, a lateral position is obtained with the upper hip flexed 90⁰ and the lower one only 45⁰. A line is drawn to connect the posterior superior iliac spines bilaterally and used as one side of an equilateral triangle; then the location of the sacral hiatus should be approximated. By palpating the sacral cornua as 2 bony prominences, the sacral hiatus could be identified as a dimple in between. A 22 gauge needle is inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone is contacted. Children will receive caudal block with 1 ml/kg of bupivacaine 0.25%.

干预措施: Caudal Block (Procedure)

结局指标

主要结局

Time at which the first analgesia required

时间窗: 24 hours after procedure

in hours

次要结局

  • Incidence of hematoma formation(Within one hour of the intervention)
  • Preoperative systolic blood pressure(5 minutes before operation)
  • Intraoperative heart rate(every 15 minutes till end of operation)
  • Preoperative diastolic blood pressure(5 minutes before operation)
  • Intraoperative diastolic blood pressure(every 15 minutes till end of operation)
  • Incidence of paresthesia(Within one hour of the intervention)
  • Incidence of vascular puncture(Within one hour of the intervention)
  • Pain assessment by the aid of FLACC score(24 hours after operation)
  • number of analgesic doses for each patient(24 hours after operation)
  • The general satisfaction score of parents(24 hours after operation)
  • Incidence of hypotension(within one hour of the intervention)
  • Preoperative heart rate(5 minutes before operation)
  • Intraoperative systolic blood pressure(every 15 minutes till end of operation)
  • Incidence of bradycardia(Within one hour of the intervention)
  • Incidence of convulsions(Within one hour of the intervention)
  • Incidence of arrhythmias(Within one hour of the intervention)
  • Incidence of injury to the underlying structures(Within one hour of the intervention)
  • Pain assessment by the aid of FLACC score(30 minutes after operation)
  • Pain assessment by the aid of FLACC score(1 hour after operation)
  • Pain assessment by the aid of FLACC score(2 hours after operation)
  • Pain assessment by the aid of FLACC score(4 hours after operation)
  • Pain assessment by the aid of FLACC score(6 hours after operation)
  • Pain assessment by the aid of FLACC score(12 hours after operation)

研究者

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

Doaa Lotfy

Assistant Lecturer of Anesthesiology

Fayoum University Hospital

研究点 (1)

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