Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in VAS scores
研究概览
简要总结
While thoracic epidural could control incisional pain after thoracotomy, an excruciating ipsilateral shoulder pain happens post thoracotomy and could affect up to 85% of thoracotomy patients. It is often difficult to manage and relatively resistant to opioids. The investigators postulate that in the presence of a functioning thoracic epidural, intrapleural bupivacaine administered through the chest tube could be effective in reducing post thoracotomy ipsilateral shoulder pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Blinded drug preparation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female, between 18 and 80 years, ASA 1-3, Scheduled for open thoracotomy
排除标准
- •ASA >3, morbid obesity BMI>40, Previous cardiac or ipsilateral thoracic surgery, Renal or hepatic failure, anemia, allergy to local anesthetics, contraindications to receive regional anesthesia, patient refusal, reiteration due to complication
研究组 & 干预措施
Control group
Patients in this group receive Normal Saline injection in the inter pleural space
干预措施: Normal saline (Drug)
Experimental group
Patients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space
干预措施: Bupivacaine-epinephrine (Drug)
结局指标
主要结局
Change in VAS scores
时间窗: from 0 hour to 24 hour
ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours
次要结局
- Forced Vital Capacity(from 0 hour to 48 hour)
- Total epidural infusion(from 0 hour to 48 hour)
- Co-analgesia consumption(from 0 hour to 48 hour)
研究者
JF Asenjo
Professor of Anesthesia
McGill University Health Centre/Research Institute of the McGill University Health Centre