Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Morphine used in the procedure
研究概览
简要总结
Vertebral compression fractures in osteoporotic patients is a major healthcare problem. Percutaneous vertebroplasty is commonly used to restore stability of the vertebra and to alleviate pain. However, the anesthetic techniques commonly used during these procedures such general anesthesia or a combination of local anesthesia and sedation are not satisfying as they are associated either with side effects or insufficient pain reduction.
This study compares the standard procedure of local anesthesia to a new technique of fluoroscopy-guided epidural anesthesia carried out by the radiologist.
The investigator's hypothesis is that fluoroscopy-guided epidural anesthesia
- provides better pain relief during the injection of high viscosity cement
- and thus, reduces the need of additional intravenous analgesia by remifentanil (morphine analogue)
- minimizes remifentanil potential adverse effects such as respiratory depression, hypoxemia, pruritus and nausea
- improves working conditions and satisfaction of the radiologist
- improves the global satisfaction of the patient
It is a monocentric, prospective, comparative and randomized study.
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
- •- Two osteoporotic vertebra compression fractures in the low thoracic or lumbar spine
- •men and women > 18 years old
- •patients with healthcare insurance
- •signed and dated informed consent
排除标准
- •men and women < 18 years
- •pregnant or breastfeeding women
- •patients under trusteeship or guardianship or patients under the protection of court
- •bad comprehension or cooperation
- •bleeding disorders
- •local or general infection
- •intracerebral or severe cardiac affections
研究组 & 干预措施
Standard group
For each vertebra treated: 10 ml of lidocaine hydrochloride 1% are applied to the skin and the lower structures including the periosteum.
An additional, anesthesia combined with intravenous analgesia by remifentanil is provided and adapted to the patients needs during the whole procedure
干预措施: anesthesia combined with intravenous analgesia by remifentanil (Other)
Epidural group
Fluoroscopy-guided epidural anesthesiaI is the identification of the epidural space using fluoroscopy and the injection of a small quantity of contrast medium or air.
According to patient's height, 10-15 ml of lidocaine hydrochloride 1% are injected by the radiologist into the epidural space.
An additional, anesthesia combined with intravenous analgesia by remifentanil is provided and adapted to the patients needs during the whole procedure
干预措施: fluoroscopy-guided epidural anesthesia (Other)
结局指标
主要结局
Morphine used in the procedure
时间窗: 1 day
Maximal target dose of remifentanil used during the procedure to obtain a satisfactory pain reduction during cement injection
次要结局
未报告次要终点