跳至主要内容
临床试验/NCT04822935
NCT04822935已完成不适用

Evaluation of Surgical Methods in Terms of Postoperative Pain in Adolescent Idiopathic Scoliosis

Istanbul University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年6月30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
31
试验地点
1
主要终点
Comparison in terms of postoperative pain

研究概览

简要总结

Scoliosis is a 3-dimensional, structural deformity of the spine. Idiopathic scoliosis is the most common type and it constitutes 75-80% of all scoliosis. Surgical methods are the most effective way to correct the deformity in patients who cannot achieve adequate improvement with supportive therapy. Adolescent idiopathic scoliosis surgeries are among the most invasive surgeries performed on children and adolescents. Large surgical incision and massive tissue damage cause severe postoperative pain. In this study, we aim to compare posterior instrumentation (PE) and vertebral body tethering (VBT) surgeries performed in adolescent idiopathic scoliosis patients in terms of anesthetic management and postoperative 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
None

入排标准

年龄范围
9 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ASA score 1-3 patients
  • Adolescent idiopathic scoliosis patients
  • Patients who accepted to be included in the study and received written parental consent

排除标准

  • Patients with vertebral anomaly due to a secondary reason
  • Patients with a diagnosed syndrome
  • Patients with a Cobb angle below
  • Patients who undergoing reoperation

结局指标

主要结局

Comparison in terms of postoperative pain

时间窗: 48 hours

Opioid consumption and VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable) for measurement of postoperative pain

次要结局

未报告次要终点

研究者

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

Nur Canbolat

Principal Investigator, M.D.

Istanbul University

研究点 (1)

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