A Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Lahey Clinic
- 试验地点
- 1
- 主要终点
- Improve pain management in patients undergoing pleuroscopy
研究概览
简要总结
This study will evaluate the potential to decrease the use of IV anesthesia drugs in patients undergoing pleuroscopy administering lidocane standardly applied to the skin in combination with atomized lidocaine applied into the pleural cavity.
详细描述
Most patient discomfort results from direct manipulation or contact with the parietal pleura during chest tube placement, talc instillation or pleural biopsy. This study intends to use combined IV, intradermal and intrapleural anesthesia during pleuroscopy procedures. Intrapleural atomized lidocaine will be applied directly to the parital pleura. This study will evaluate intravenous anesthesia reduction in subjects treated with intrapleural lidocaine, reduction in total procedure timeby minimizing interruptions due to poor pain control, reduce perioperative pain scores and improve patient comfort nad to determine safety of fixed dosage of 3 mg/kg intrapleural lidocaine given during pleuroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with pleural disease
- •Patients undergoing pleuroscopy with talc with or w/o biopsy
- •Patients aged 18 - 85
- •Patients capable of signing informed consent
排除标准
- •Severe congestive heart failure
- •Hepatic failure, bilirubin > 2mg/dl, ALT,AST 3XULN
- •Prior use Lidocaine in 48 hrs
- •Hx SA drug reaction to lidocaine or amide local anesthetics
- •Second or third degree heart block (w/o pacemaker)
- •Sever sinoatrial block (w/o pacemaker)
- •Concurrent treatment with quinidine, flecainide, dsopyramide, procainamide (ClassI antirrhythmic agents)
- •Prior use or amiodarone hydrochloride
- •systolic BP < 90mmHg
- •bradycardia
- •accelerated idioventricular rhythm
研究组 & 干预措施
Lidocaine Group
Patients randomized to arm two will receive a reduced topical dose of lidocaine of 2mg/kg and additional lidocaine 3mg/kg infused into the pleura cavity. Duration of procedure will be monitored from the time initial dose of intradermal lidocaine until the start of surgical wound closing, pain scale will be administered prior to the procedure and at the end of the procedure. Lidocaine serum levels will be monitored at 30, 60, and 120 minutes after initial intradermal administration of lidocaine.
干预措施: lidocaine hydrochloride (Drug)
结局指标
主要结局
Improve pain management in patients undergoing pleuroscopy
时间窗: pre-procedure and post procedure
次要结局
- Reduction of procedure time Measurement of lidocaine serum levels at 30, 60, 120(time of procedure will be documented;lidocaine levels monitored throught out)