Epidural Anesthesia as an Alternative for Management in Acute Pancreatitis, a Randomised Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hospital days stay between two groups
研究概览
简要总结
Acute pancreatitis is a common urgency with a mortality rate of up to 30% , decreased blood flow in the pancreatic microcirculation. It seems to be the main cause of the pathophysiology of acute pancreatitis. Today, there have been many attempts in the management of pancreatitis but no established management seems to be ideal. The epidural block is an anesthetic technique used to provide highly peri and post-operative analgesia, also plays an important role in improving the gastrointestinal vascular perfusion (due to sympathetic blockade that this technique produces) so this anesthetic technique is proposed as an alternative to both clinical treatment as an analgesic for acute pancreatitis.
详细描述
The main objective of the study is to evaluate the therapeutic effects of epidural block in patients with acute pancreatitis, comparing day hospital stay among patients receiving intravenous analgesic treatment and patients who are undergoing epidural block.
It is a (prospective, comparative, longitudinal, experimental, randomized) controlled clinical trial. They include patients who are diagnosed with acute pancreatitis at the Naval General Hospital of High Specialty. Two groups were taken by random assignment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute pancreatitis
- •Patients who agree to participate in the study
排除标准
- •Patients who do not agree to participate in the study
- •Patients who experience any absolute contraindication to epidural block
- •Patients with platelet counts below 80,000 mcl
- •Patients with data gastrointestinal or urinary bleeding
研究组 & 干预措施
Epidural anesthesia
Epidural anesthesia placed at L1-L2 Epidural infusion of ropivacaine 0.2% + 3-4 mcg/ml fentanyl + saline 0.9% (100 ML) 3-5ml/ hr during 120 hours
干预措施: Epidural anesthesia (Drug)
intravenous analgesia
ketorolac 1mg/kg every 8 hours or metamizol 15 mg/kg every 8 hrs and intravenous opioids (buprenorphine 3 mcg / kg or tramadol 1mg/ kg in continuos infusion
干预措施: intravenous analgesia (Drug)
结局指标
主要结局
Hospital days stay between two groups
时间窗: 10-15 days
Day hospital stay were compared between the analgesic management with epidural and intravenous analgesic management
次要结局
- Efficacy of Epidural pain control(24, 48, 72, 96,120 hours)
- Decreased pancreatic enzymes(24,48,72,96,120 hours post dose)