Interest of Improved Recovery After Surgery (IRAS) Management [RAAC in French] in Percutaneous Vertebroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety
研究概览
简要总结
This research aims to demonstrate the benefits of the RAAC program for patients undergoing cementoplasty, in particular on their level of anxiety and pain control throughout the perioperative phase.
详细描述
The aim of the study is to compare the preoperative anxiety of patients hospitalized for a percutaneous vertebroplasty, depending on whether or not they are managed in an RAAC program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 80 years or ≥ 18 years with oncological history;
- •Patient with vertebral compression fracture with indication for percutaneous vertebroplasty;
- •Patient seen in preoperative anesthesia / radiology consultation more than 4 days before the date of the vertebroplasty;
- •Having expressed their consent to participate in the study.
排除标准
- •Patient with a contraindication to percutaneous vertebroplasty, such as coagulation disorders, or an allergy or hypersensitivity to any of the products administered during the procedure;
- •Patient not affiliated to a social security scheme;
- •Patient participating in another clinical trial during the follow-up period;
- •Inability to understand information related to the study (linguistic, psychiatric, cognitive reason, etc.).
研究组 & 干预措施
RAAC program
If the patient is under the "RAAC" group, he/she will then be received in consultation by a RAAC specialist nurse, between the anesthesia / radiology consultation and the intervention. This RAAC nurse will explain the procedure and show him/her an information video on vertebroplasty. Information about managing anxiety and pain will also be provided. In addition, the day after the patient leaves the clinic, the RAAC nurse will call him/her to inquire.
干预措施: Vertebroplasty (Procedure)
Standard management program
If the patient is under the "control" group, he/she will be taken care of according to the standard protocol after a surgery in percutaneous vertebroplasty. The patient will not have a consultation with the specialized nurse.
干预措施: Vertebroplasty (Procedure)
结局指标
主要结局
Superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety
时间窗: 10 days
The main analysis consists of testing the superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety, evaluated on a numerical scale of 0 to 10
次要结局
- Pain evaluation(10 days)
- Functional impotence(10 days)
- Patient satisfaction(10 days)
- Consumption of analgesics(10 days)