Comparison of Continuous Epidural and Continuous Paravertebral Blockade in Postoperative Analgesia After Videothoracoscopic Lung Lobectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- pain intensity measured in VAS in predetermined time intervals after the operation
研究概览
简要总结
Thoracic surgery correlates with significant pain in postoperative period. In order to alleviate the pain various combinations of pharmaceuticals and administration methods are employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain various operation techniques are used. In traditional thoracotomy epidural anesthesia remains a golden standard. Epidural anesthesia however demands high skills to be performed correctly and presents an increased risk of grave complications. In videothoracoscopic (VATS) operations paravertebral blockade can be employed, yet there is no certainty if its efficacy after lung lobectomy. We therefore designed a prospective, randomized, parallel group, single site study to test the hypothesis, that continuous paravertebral blockade is as efficient in postoperative pain reduction as continuous epidural blockade and possesses a higher safety profile.
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
- 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
- •American Society of Anesthesiologists (ASA) physical status 1-3
- •undergo videothoracoscopic lung lobectomy
- •forced expiratory volume in 1 second (FEV1) >1,5 l/min
- •no contraindications for epidural anesthesia and paravertebral nerve blockade
- •ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.
排除标准
- •prior to the study: contraindications for local anesthesia, ASA>3, FEV1<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.
- •during the study: failure to place epidural or paravertebral catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).
结局指标
主要结局
pain intensity measured in VAS in predetermined time intervals after the operation
时间窗: up to 96 hrs after the surgery
次要结局
- frequency of respiratory complications: atelectasis or pneumonia(up to 96 hrs after surgery)
- cumulative opioid (morphine) consumption(up to 96 hrs after surgery)
- respiratory parameters indirectly indicating conditions for efficient cough: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC)(up to 96 hrs after the surgery)
- frequency of side effects of regional anesthesia: urine retention resulting in necessity of bladder catheterization, hypotension, respiratory depression(up to 96 hrs after surgery)