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临床试验/NCT06984874
NCT06984874招募中不适用

Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy: A Prospective Controlled Trial

Menoufia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Degree of pain

研究概览

简要总结

This study aims to evaluate the influence of ultrasound-guided erector spinae plane block on postoperative pain and diaphragmatic dysfunction in pediatric patients undergoing thoracoscopic sympathectomy.

详细描述

Pain may occur after pediatric thoracic surgery in cases such as skin incision creation, rib traction, and drain placement, and in other cases, such as rib nerve injury. Such pain is highly unfavorable to pediatric patients' recovery as it may lead to reduced cough strength for clearing secretions, decreased functional residual capacity, and pulmonary complications such as atelectasis and pneumonia.

Erector spinae plane block (ESPB) is a novel trunk block to relieve chronic neuropathic pain. Since then, it has gained prominence as a regional anesthesia technique with the potential to revolutionize postoperative pain management, and it has been effectively administered not only for the management of perioperative pain for a wide variety of surgeries but also for the management of acute post-traumatic pain and chronic pain.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age from 6 to 16 years.
  • •Either sexes (male or female).
  • •American Society of Anesthesiologists (ASA) physical status I-II.
  • •Scheduled for bilateral thoracoscopic sympathectomy under general anesthesia.

排除标准

  • •History of allergy to local anesthetics.
  • •Abnormal liver/kidney function.
  • •Severe spinal deformities.
  • •Bleeding or coagulation disorders.
  • •Skin damage or infection at the proposed puncture site.

研究组 & 干预措施

Erector spinae plane block group

Experimental

Patients will receive bilateral erector spinae plane block after the induction of general anesthesia as a study group.

干预措施: Erector spinae plane block (Other)

Control group

Active Comparator

Patients will not receive the block after the induction of general anesthesia as a control group.

干预措施: General anesthesia (Other)

结局指标

主要结局

Degree of pain

时间窗: 24 hours postoperatively

Postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed on arrival at the post-anesthesia care unit (PACU), 1, 2, 4, 8, 12, and 24 h postoperatively.

次要结局

  • Total analgesic consumption(24 hours postoperatively)
  • Anesthetic consumption: minimum alveolar concentration(Intraoperatively)
  • Diaphragmatic excursion(24 hours postoperatively)
  • Time to the first request for the rescue analgesia(24 hours postoperatively)
  • Recovery profile(24 hours postoperatively)
  • Incidence of complications(24 hours postoperatively)

研究者

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

SAFAA MOHAMED SALLAM

Assistant Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Faculty of Medicine, Menoufia University, Egypt.

Menoufia University

研究点 (1)

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