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临床试验/NCT04038229
NCT04038229已完成不适用

Biopsychosocial Model for a Multidisciplinary Perioperative Care Pathway in Patients Undergoing Posterior Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年12月9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
33
试验地点
2
主要终点
postoperative pain

研究概览

简要总结

Posterior Spinal fusion (PSF) is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by extensive tissue trauma, and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain.

The consequences of untreated acute pain are known and can also contribute to chronification in pain.

详细描述

Surgical correction of adolescent idiopathic scoliosis (AIS) is indicated for severe deformity. Posterior Spinal fusion (PSF) for AIS is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by a large surgical incision, extensive tissue trauma, risk of blood loss, longer operating times and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. All of this can, along with under-treatment of postoperative pain, be an important delaying factor in postoperative recovery and rehabilitation with a late hospital discharge and increased patient dissatisfaction. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain.

The consequences of untreated pain are known and can also contribute to chronification in pain.

The incidence of chronic post-surgical pain after scoliosis fusion is 22% at 6 months and 11-15% at 1 to 5 years postoperatively. It is therefore important to minimize the pain during the first postoperative days. Untreated pain in patients is far from benign with significant negative short and long term consequences with accompanying reduction in rehabilitation duration, sleep quality of life. To date, there is no scientific evidence that some analgesic policy is superior, making adequate and safe pain relief and associated anti-emetic therapy after PSF a challenge makes for all healthcare providers involved.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • approved written informed consent by parent or legal representative
  • idiopathic adolescent scoliosis
  • planned for elective surgery: posterior spinal fusion

排除标准

  • other types of scoliosis
  • chronic opioid usage (more than 3 months)
  • known unstable psychiatric medical condition

结局指标

主要结局

postoperative pain

时间窗: From admission postoperative anesthesia care unit (PACU) up to 3 months postoperatively

Evaluation of pain at rest and during mobilization using 11 point numeric rating scale daily during hospital admission and is continued after discharge up to 3 months postoperatively

次要结局

  • daily activity(From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery)
  • sleep(From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery)
  • mobility(From day of surgery until hospital discharge (approximately 7 days))
  • evaluation of opioid-related side effect(From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery)

研究者

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

Davina Wildemeersch

Principle investigator

University Hospital, Antwerp

研究点 (2)

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