Comparison of the Hemodynamic Effect Between the Paravertebral Block and Thoracic Epidural in Esophageal Surgery With Thoracotomy .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Frequency of hypotension episodes
研究概览
简要总结
Continuous Paravertebral block (PVB) was reported to provide less episodes of hypotension than continuous thoracic epidural block (TEB). The maintenance of optimal tissue perfusion is essential for esophageal anastomosis in patients undergoing oesophagectomy. the aim of this study is to compare Hemodynamic effect of continous PVB compared to TEB , in patient undergoing oesophagectomy with laparoscopy and thoracotomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA score 1 to 3
- •oesophagectomy : abdominal time with laparoscopy ans thoracic time with thoracotomy
排除标准
- •pregnancy
- •Uncooperative patient
- •patient refusal
- •Coagulopathy
- •allergy to local anesthetic
- •Psychological Disorders
- •Failure to install the epidural or paravertebral catheter. The patient will therefore be excluded secondarily but will be able to benefit from an alternative technique for the management of his pain.
- •Skin infection at the puncture site
- •Allergy to local anesthetics
- •Esophagectomy with cervical surgical time
- •Patient with chronic pain EVA> 4 before surgery.
研究组 & 干预措施
continous paravertebral block
echoguided thoracic continous paravertebral block was placed before the surgery.
A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.
干预措施: paravertebral block (Other)
continous paravertebral block
echoguided thoracic continous paravertebral block was placed before the surgery.
A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.
干预措施: ropivacaine (Drug)
continous paravertebral block
echoguided thoracic continous paravertebral block was placed before the surgery.
A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.
干预措施: Sufentanil (Drug)
continous Thoracic epidural block
thoracic epidural catheter was inserted before the surgery. A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.
干预措施: thoracic epidural block (Other)
continous Thoracic epidural block
thoracic epidural catheter was inserted before the surgery. A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.
干预措施: ropivacaine (Drug)
continous Thoracic epidural block
thoracic epidural catheter was inserted before the surgery. A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.
干预措施: Sufentanil (Drug)
结局指标
主要结局
Frequency of hypotension episodes
时间窗: during perioperative until first 24 hours post operative
The frequency of hypotension episodes defined by a mean arterial pressure (MAP) less than 70mmHg or a decrease in MAP greater than 20% when compared with the preoperative value
次要结局
- Volumes of fluid administered(during perioperative until the first 24h hours post operative)
- total amount of morphine consumption(during first 48 hours post operative)
- visual analog scale(during first 48 hours post operative, at 3 months and 6 months)
- Total amount per patient and per group of vasopressins amines(during perioperative until first 24 hours post operative)
- Frequency of use of vasopressor agents(during perioperative until first 24 hours post operative)
- DN2 score(during first 48 hours post operative, at 3 months and 6 months)
- Frequency of surgical complications(during first 48 hours post operative)
- Frequency of pulmonary complications(during first 48 hours post operative)
- total amount and frequency of Post-operative anti-emetic consumption(during first 48 hours post operative)
- Death(up to 28 days postoperative)