Postoperative Pain Management After Minimally Invasive Esophagectomy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Intraoperative hypotension ( > 30% decline in the preoperative systolic/diastolic blood pressure)
研究概览
简要总结
Esophagectomy is a major surgical procedure often associated with significant morbidity and mortality and significant level of postoperative pain. In contrast to open esophagectomy where epidural pain control has been considered as a gold standard and could be crucial in affecting outcome the analgesic scheme for minimally invasive esophagectomy (MIE) is yet to be established. We would like to compare continuous epidural analgesia and continuous paravertebral block combined with single shot subcostal transversus abdominis plane (TAP) block in the analgesic effects, levels of cytokines, and postoperative complications in patients receiving MIE.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a physical status between ASA I and III
- •20 - 75 years of age
- •Patient has signed an informed consent
- •Without contraindication of GA, EA or PVB
排除标准
- •ASA > III
- •Inability to provide informed consent
- •Bleeding disorders
- •Being pregnant
- •Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs),
- •Allergy to amide-type local anesthetics or NSAIDs
- •Infection at the thoracic paravertebral injection site
- •Severe spine or chest wall deformity
- •Patients with major psychosis or drug and alcohol abuse
- •Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
- •Patients with physical disability that precludes complete cooperation
研究组 & 干预措施
Epidural
Epidural catheters will be applied at the T6-8 level prior to the induction. 6 ml of 2% xylocaine with 1 in 200,000 epinephrine administered before surgery. During the surgery, 2% xylocaine with 1 in 200,000 epinephrine infusion will be administered at a rate of 2-10 ml/hour adjusted according to patient's blood pressure. After surgery, 0.125% levobupivacaine with 2.5μg fentanyl and 1 in 400,000 epinephrine will be given at a rate of 0.10-0.15 ml kg-1 h-1 (0.5 h lock and 2 ml bolus) through a patient-controlled infusion pump.
干预措施: continuous epidural infusion (Other)
combined PVB TAP
Paravertebral catheterization into the paravertebral region ipsilateral to the VATS incision as described by Murata at the level of T7-8 will be performed. 10 ml of 2% xylocaine with 1 in 200,000 epinephrine to initiate analgesia. During the surgery, 2% xylocaine with 1 in 200,000 epinephrine infusion will be administered at a rate of 2-10 ml/hour adjusted according to patient's blood pressure. After the surgery, 0.125% levobupivacaine with 2.5μg fentanyl and 1 in 400,000 epinephrine will be administered at the rate of 0.10-0.15 ml kg-1 h-1 (0.5 h lock and 2 ml bolus) through a patient-controlled infusion pump.
Ultrasound-guided (USG) subcostal TAP block will be performed at the end of surgery. Fifteen milliliters of 0.5% levobupivacaine with 1 in 400,000 epinephrine will be injected in incremental doses on each side of the abdomen.
干预措施: combined paravertebral infusion and single shot of TAP block (Other)
结局指标
主要结局
Intraoperative hypotension ( > 30% decline in the preoperative systolic/diastolic blood pressure)
时间窗: during operation
次要结局
- NRS pain score(postoperative day 0 to 4)
研究者
Nai Liang Li
MD
Sun Yat-sen University