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临床试验/NCT05289401
NCT05289401已完成不适用

Analgesic Effect of Ultrasound Guided Errector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
primary outcome

研究概览

简要总结

comparison between the erector spinae block and caudal block with the aid of the of ultra sound in children as regard time of request of rescue analgesia , degree of intra and post operative pain relief , effect of hemodynamic stability and incidences of complication in open renal surgeries .

详细描述

Open Renal surgeries (pyeloplasty and nephrectomy) is associated with significant postoperative pain. Adequate postoperative analgesia is important to allow for early mobilization and discharge of the patients .Systemic opioids are usually not sufficient for pain control after renal surgeries in children. The use of opioid in pediatrics has many side effects such as somnolence, vomiting, and up to respiratory depression.

Neuraxial analgesia is usually required in these operations in combination with general anesthesia. Neuraxial analgesia decreases morbidity, mortality, opiate exposure, shortens post anesthesia recovery room time and hospital stay. However, it is usually associated with many complications as urinary retention and excessive motor block.

Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. It can be used for analgesia in different renal surgeries providing adequate pain relief in the post- operative period .

Paediatric regional anaesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anaesthetic practice. It offers many advantages to both the patient and the hospital. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids without the complications of neuraxial anesthesia. Considerable progress has been made in the practice of PRA over the past few years including availability of information on safety and incorporation of ultrasound guidance. Novel regional anaesthesia (RA) techniques, especially the anterolateral and the posterolateral trunk blocks, show promise .

The erector spinae plane block (ESPB), one of the posterolateral trunk blocks, was first described by Forero et al. in 2016 and has been used by many anaesthesiologists for perioperative pain relief 4. Its mechanism of action is spreading of local anesthetic into multiple paravertebral spaces after injection into the interfascial space between the transverse process of the vertebrae and the erector spinae muscle. It can be used for postoperative analgesia for longer period and decrease the use of opioids with less complications in several pediatric surgeries including nephrectomy and pyeloplasty.

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
None

入排标准

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

入选标准

  • Patients 2-6 years old.
  • American society of anesthesiologists classification (ASA) I and II .
  • Patients undergoing unilateral open renal surgeries.

排除标准

  • Refusal of block.
  • Bleeding disorders (platelets count < 150,000; INR >1.5; PC< 60%).
  • Skin lesion, wounds or infection at the puncture site.
  • Known allergy to local anesthetic drugs.
  • Contraindications to neuraxial block as sepsis, severe aortic stenosis, increased intracranial pressure.

结局指标

主要结局

primary outcome

时间窗: at the time of transfer from PACU and then at 1, 2, 3, 4, 6, 8 and 12 hours postoperatively

The first time to require rescue analgesia in minutes (from the time of erector spinae block or caudal injection to the first registration of CHEOPS pain score more than 6)

次要结局

  • secondary outcome(at time of transfer to PACU and then at 1, 2, 3, 4, 6, 8 and 12 hours.)

研究者

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

Chahenda Salem

M.Sc

Cairo University

研究点 (2)

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