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临床试验/NCT06498583
NCT06498583已完成不适用

Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Pain and Sleep Quality of Infants With Congenital Pulmonary Cystic Disease After Thoracoscopic Surgery

Lei Xiaoming1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年1月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
postoperative FLACC score

研究概览

简要总结

This study intends to evaluate the effect of erector spinae plane block on postoperative analgesia and sleep quality in infants with congenital cystic pulmonary disease after thoracoscopic surgery, and provides reference for perioperative pain treatment in children.

详细描述

Severe pain may occur after pediatric thoracic surgery, such as skin incision, rib traction, drainage tube placement, or intercostal nerve dysfunction caused by suture. Pain may cause weakened coughing power to clear secretions, decreased functional residual capacity, leading to pulmonary complications such as atelectasis and pneumonia, and postoperative acute pain develops into chronic pain. It has been reported that postoperative sleep disorders are associated with increased pain scores, which are very unfavorable for postoperative rehabilitation of pediatric patients. In clinical practice, because infants cannot accurately describe pain, their postoperative pain management may not be sufficient and has not received enough attention. But, some studies have shown that infants may feel more severe pain than adults, and the pain has a more obvious and lasting effect on infants and young children than on adults.

Congenital pulmonary cystic disease is a rare congenital pulmonary developmental abnormality in clinic. It can't heal itself and is easy to cause various complications. Once diagnosed, surgical treatment should be considered immediately.

In the past experience, thoracic epidural block and thoracic paravertebral nerve block are commonly used for postoperative analgesia in thoracic surgery, but they have taboos such as abnormal coagulation function, high technical requirements and potential risks of serious complications.

Since the erector spinae plane block (ESPB) was first reported and successfully implemented in 2016, because it is far away from the neural axis, major vascular structures, pleura and other structures, with a lower possibility of complications, simpler operation and higher safety, it has been widely used in perioperative analgesia and acute and chronic pain in cardiothoracic surgery, breast surgery, abdominal surgery, spinal surgery, etc. However, the reports on pediatric patients are still mainly case reports, and there is a lack of large-sample randomized controlled clinical trials. Therefore, this study intends to perform erector spinae plane block under ultrasound guidance to observe the effect on postoperative analgesia and sleep quality in pediatric thoracoscopic surgery.

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, Investigator)

入排标准

年龄范围
1 Month 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) status I-II
  • age 1 month - 12 mouths old
  • preoperative diagnosis was congenital cystic lung disease
  • thoracoscopic lung lesion resection(lung lobectomy or segmentectomy)

排除标准

  • patient with a history of allergy to amide local anesthetics
  • family members refused to participate in the study.
  • combined congenital heart disease
  • patient with skin damage or infection at the proposed puncture site
  • patients with scoliosis

研究组 & 干预措施

P group

Experimental

干预措施: Incision infiltration of local anesthesia (Procedure)

E group

Experimental

干预措施: erector spinae plane block (Procedure)

P group

Experimental

干预措施: Ropivacaine (Drug)

E group

Experimental

干预措施: Ropivacaine (Drug)

结局指标

主要结局

postoperative FLACC score

时间窗: 2, 4, 6, 12, 24, 48 hours after operation

次要结局

  • Number of participants with emergence agitation as assessed by PAED(from extubation to the child is sent back to the ward, an average of 40 minutes)
  • the amount of postoperative rescue analgesia ( with a FLACC score of >4)(2, 4, 6, 12, 24, 48 hours after operation)
  • Postoperative sleep quality score(1, 2, 3, 4, 5, 6, 7 days after operation)

研究者

发起方
Lei Xiaoming
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lei Xiaoming

chief physician

Xibei Hospital

研究点 (1)

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