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临床试验/NCT05832671
NCT05832671已完成不适用

Ultrasound Guided Erector Spinae Muscle Block on Postoperative Pain in Pediatric Patient Undergoing Hip Reconstruction Surgeries

Assiut University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月3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
70
试验地点
2
主要终点
Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale 2 hours postoperative

研究概览

简要总结

Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia.

详细描述

Regional anesthetic techniques have been widely used for pain management in a variety of pediatric surgeries, as they increase the efficiency of postoperative pain control; minimize parenteral opioid requirements, and improve both patient and parent satisfaction as well. The erector spinae muscle plane block (ESB) is an evolving regional anesthetic technique gaining popularity in pediatric procedures. Erector spinae block is an effective regional anesthesia method as it blocks both somatic and visceral pain by injecting the local anesthetic solution into the inter-fascial space between the transverse process and the erector spinae muscle, it is performed by distributing local anesthetic into several paravertebral spaces. it was reported a successful ultrasound-guided ESP block performed at the L4 transverse process level provided postoperative analgesia in adult patients undergoing hip and proximal femur surgeries.

Caudal block (CB) is a well-established remarkable practice because of its simplicity, safety, and effectiveness. A single-shot caudal block with a local anesthetic agent, such as bupivacaine, is a standard procedure, and analgesia is provided during pediatric orthopedic surgeries in the lower limbs; unfortunately, its action stops early in the postoperative period.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • • ASA I and II,
  • aged 2-7 years
  • scheduled for unilateral surgical hip reconstruction under general anaesthesia.

排除标准

  • Children with spinal anomalies,
  • altered mental status or a history of developmental delay,
  • infection at the site of injection,
  • history of allergy to local anaesthetics
  • history of blood disease or coagulopathy,
  • Patient's guardian refusal to participate in the study

结局指标

主要结局

Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale 2 hours postoperative

时间窗: first postoperative 24 hours

To evaluate the quality of postoperative analgesia using the FLACC. Each category is scored on the 0-2 scale, which results in a total score of 0-10. 0=relaxed and comfortable, 1-3= mild discomfort, 4-6= moderate pain and 7-10= sever discomfort or pain or both

次要结局

  • Emergence agitation using Paediatric Anaesthesia Emergence Delirium (PAED) scale.(24 hours)
  • total analgesic requests(24 hours)
  • time to the first analgesic request(recorded in hours for the first 24 hour)

研究者

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

Shimaa Abbas Hassan

lecturer

Assiut University

研究点 (2)

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