Randomised Double Blind Controlled Study of the Effectiveness of Paravertebral Nerve Block in Decreasing Analgesia Requirements and Improving Patient Experience During Interventional Hepatic Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Dose of intravenous sedation required during and after the procedure
研究概览
简要总结
This study is aimed at assessing whether performing a paravertebral block (a type of regional pain relief) can reduce the pain and anxiety patients experience during radiological procedures on the liver.
详细描述
Percutaneous procedures of the liver can be very painful and range from bliliary drain insertions to tumor ablation procedures. The study will randomize patients in two groups, one receiving a paravertebral nerve block prior to the procedure and one receiving a sham procedure in which saline will be injected in the paravertebral space. Pain scores and use of IV sedation will be monitored post procedure and both groups will be compared to assess whether paravetebral nerve blocks are effective at reducing pain in patients receiving such procedures.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
- •Subjects referred for liver/biliary interventions to the angiography department.
- •Written informed consent to participate in the study. Ability to comply with the requirements of the study procedures
排除标准
- •Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
- •Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Patients will only be excluded on this basis following discussion with another interventional radiologist.
- •Subjects who are uncooperative or cannot follow instructions. Mental state that may preclude completion of the study procedure or ability to obtain informed consent.
- •Pregnant or nursing female subjects. Patient who are to undergo liver biopsy or routine biliary tube exchange. Patients with neurological/spinal conditions, or a BMI over 40, that would prevent safe/effective or well-targeted paravertebral blockade.
- •Patient unable to tolerate the paravertebral block procedure, for example due to inability to lie prone
结局指标
主要结局
Dose of intravenous sedation required during and after the procedure
时间窗: 1 hour
次要结局
- Procedure duration(1 hour)
- Complication rate of liver procedure(24 hours)
- Complication rate of paravertebral block(1 hour)
- Improvement in analogue pain scoring after the procedure(1 hour)
研究者
Richard Lindsay
MD
McGill University Health Centre/Research Institute of the McGill University Health Centre