Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Level of Pain
研究概览
简要总结
Gastrostomy is an intra-gastric nutritional enteral device that could be put in place by percutaneous technique under radiological guidance: allowing local anesthesia. However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action. The association of these two drugs could enhance the analgesia post procedure. The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.
详细描述
Gastrostomy is an intra-gastric nutritional enteral device, allowing the nutritional support for patients presenting oral feeding disorders. Gastrostomy could be put in place by different manners:
- Chirurgical technique or endoscopy: with general anesthesia;
- Percutaneous technique under radiological guidance: allowing local anesthesia. This last one is better tolerated by weak patients, and involves less complication.
However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action.
The association of these two drugs could enhance the analgesia post procedure. Indeed, pain felt during the twenty four hours post procedure seems to be the most frequent adverse effect reported by patients.
Pain could decrease significantly when Ropivacaine is added to the reference Xylocaine. Ropivacaine had already proved its efficacy in association with other antalgics.
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
- Single (Participant)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lidocaine and Ropivacaine
Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance
干预措施: Lidocaine (Drug)
Lidocaine and Ropivacaine
Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance
干预措施: Ropivacaine (Drug)
Lidocaine
Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance
干预措施: Lidocaine (Drug)
结局指标
主要结局
Level of Pain
时间窗: 24 hours
Two points diminution for maximal pain felt during a twenty four hours after percutaneous gastrostomy under radiological guidance. It will be measured with a visual analogue scale starting at zero for no pain and ending at ten for maximal pain felt.
次要结局
- Level of quality of life(10 days)
- Level of Anxiety and Depression(10 days)
- Level of satisfaction(10 days)