Influence of Catheter Insertion Distance on the Quality of Thoracic Epidural Analgesia in the Context of Thoracotomy Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Quality of pain relief during cough
研究概览
简要总结
This study is designed to compare thoracic epidural catheter insertion distances, in order to determine which is the best for pain relief following a thoracotomy.
HYPOTHESIS :
- The quality of epidural analgesia upon coughing one hour following the end of surgery will not be inferior if the catheter is inserted 7 cm in the epidural space, versus 3 and 5 cm.
- The quality of epidural analgesia upon coughing at 24 hour will not be inferior if the catheter is inserted 3 cm in the epidural space, versus 5 and 7 cm.
详细描述
Thoracic surgery such as posterolateral thoracotomy is associated with severe postoperative pain. Pain control is particularly important, as adequate analgesia allows rapid mobilisation and prevents complications related to immobility. Over the last years, thoracic epidural analgesia has become increasingly popular and is now considered the gold standard after thoracotomy. Thoracic epidural analgesia improves pain relief and also significantly decreases the incidence of morbidity and mortality following pulmonary resection. It also reduces the length of stay in the hospital and long-term pain 6 months after surgery. This method is now offered to a majority of patients undergoing a thoracotomy in our hospital.
The placement of a catheter in the thoracic epidural space remains a challenge for the anesthesiologist. Suboptimal placement of the catheter within the epidural space can result in inadequate pain relief. The distance at which the catheter must be advanced in the thoracic epidural space remains unknown. Insertion distance could influence the initial quality and distribution of sensory blockade, its duration, or both. Therefore, this study is designed to compare three catheter insertion distances, in order to help determine which is best for pain relief after a thoracotomy.
Methods :
- Insertion of the epidural catheter :
Patients will be randomly assigned to the following groups :
- Group 1 : 3 cm insertion
- Group 2 : 5 cm insertion
- Group 3 : 7 cm insertion
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older undergoing an elective thoracotomy.
排除标准
- •Infection or sepsis
- •Coagulopathy
- •Hypovolemia
- •Allergy to local anesthetics
- •Neuropathy that could affect study assessments
- •Pregnancy
结局指标
主要结局
Quality of pain relief during cough
时间窗: At one hour and 24 hours after surgery
次要结局
- Quality of pain relief at rest(At one hour and 24 hours after surgery)
- Loss of cold sensation around the wound(At one hour and 24 hours after surgery)
- Proportion of failed epidurals(At one hour and 24 hours after surgery)
- Wound palpation pain(At one hour and 24 hours after surgery)
- Cumulative bupivacaine and morphine consumption(At one hour and 24 hours after surgery)