A Randomized, Controlled Trial on Patients Undergoing Cardiac Implantable Electronic Device Implantation With Local Anaesthesia and Sedation With and Without Pectoral Nerve Block
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Perioperative pain scores
研究概览
简要总结
Implantation of cardiac implantable electronic devices are generally carried out using intermittent intravenous conscious sedation combined with local anaesthesia. The main advantage of this technique is in avoiding the potential risks of general anaesthesia. However, the use of this Sedation - Local Anaesthesia technique is not without complications. Peri -procedural hypoxaemia and hypotension are well recognised complications of this technique.
The pectoral nerves (Pecs) blocks are novel techniques to block the pectoral, intercostobrachial, third to sixth intercostals, and the long thoracic nerves. PECS block targets the lateral and median pectoral nerves at an interfascial plane between the pectoralis major and minor muscles.
A case report by Fujiwara et al has described the use of this technique to provide good analgesia during and after these implantation procedures surgery. Pectoral nerves block along with minimal sedation has been used as a safe technique in our local set up as well.
Hence, we propose a randomized, single center, controlled trial on patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation with and without Pectoral Nerve Block.
详细描述
Intervention group:
Pectoral nerve block will be performed by anaesthetist (not blinded) in cardiac catheterization laboratory using ultrasound guidance and strict aseptic technique.
Control group:
A sham "block" will be performed by anaesthetist in cardiac catheterization laboratory using strict aseptic technique.
Patients of both groups will be monitored by the Cardiologist ( performing the procedure) and the Nurse from the monitoring room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilled the indication for CIED implantation as defined in 2008 guidelines for device-based therapy of cardiac rhythm abnormalities
排除标准
- •Those who receives subcutaneous implantable cardioverter defibrillator
- •Vulnerable subjects (children, prisoners, cognitive impaired persons)
- •Known history of allergy to local anaesthetic medications
结局指标
主要结局
Perioperative pain scores
时间窗: 2 years
Incidence of hypoxia, hypotension and hypopnea in the perioperative period
时间窗: 2 years
Total dose of sedation used
时间窗: 2 years
Post-anaesthetic discharge score
时间窗: 2 years
Perioperative sedation scores
时间窗: 2 years
次要结局
- Patient satisfaction scores(2 years)
- Procedurist satisfaction scores(2 years)