Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain. ''MEZO''
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Costs of each Intravenous Patient Controlled Analgesia (PCA)
研究概览
简要总结
More than 230 million surgical operations are been realized all over the world every year. A surgical intervention can cause postoperative acute pain. The management of postoperative acute pain is multimodal and the use of patient-controlled analgesia (PCA) is often a part of this Pain-Management.
Intravenous PCA has established itself as a therapeutic concept and constitutes the reference treatment for the management of postoperative acute pain for the first 48 hours. The PCA offers patients autonomy in managing their pain with the intravenous delivery of morphine on demand.
Since 2017 PCA Zalviso is marketed. It allows the sublingual administration of sufentanil and it does not require venous access. It seems interesting to allow the early rehabilitation of patients who are no longer limited in their movements by an infusion. However, its acquisition cost appears to be higher than that of the intravenous PCA. In order to verify this hypothesis, the investigators propose to compare the set of costs associated with the use of sublingual PCA with those of intravenous PCA in the management of acute postoperative pain (less than 72 hours) in the context of patients benefiting from the placement of a total knee arthroplasty.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients able to express consent
- •signed written informed consent form
- •patient covered by national health insurance
- •patient undergoing total knee arthroplasty and requiring postoperative analgesia with the use of a PCA (patient controlled analgesia)
排除标准
- •obstruction to participate
- •patient non covered by national health insurance
- •patient requiring a stay in intensive care immediately after the surgery
- •patient unable to use a PCA a assessed by the investigator
结局指标
主要结局
Costs of each Intravenous Patient Controlled Analgesia (PCA)
时间窗: until 72 hours after knee arthroplasty
Comparison of costs associated with the use of sublingual PCA to those of intravenous PCA
次要结局
- Length of hospitalization(until 72 hours after knee arthroplasty)
- Efficiency of acute postoperative pain management(until 72 hours after knee arthroplasty)
- Global satisfaction of the patient(until 72 hours after knee arthroplasty)