PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique: Outcome Influence on Patient Underwent Pancreatic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Incidence of catheters malfunctions in LOS and X-ray group
研究概览
简要总结
The use of epidural catheters for postoperative analgesia in pancreatic surgery is recommended by the guidelines of the ERAS society. Some studies claim it may expose to hemodynamic alterations that may compromise outcome and increase postoperative complications, attributable to a malfunction of the catheter itself, often linked to a bad positioning, since this is usually positioned with LOS technique. Our hypothesis is that a positioning made using the radiographic guide the day before the intervention can significantly reduce the number of catheter's dysfunctions.
详细描述
About 30% of epidural catheters are reported to have hypo or hyper functioning behaviour. This has and impact on postoperative pain control and can affect also surgical and global outcome since it is known that a malfunctional catheter carries an increased complication's rate.
Our hypothesis is that rx-guided positioning can reduce the incidence of catheter malfunction afrom 30 to 15 %.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •scheduled for open pancreatic surgery
- •ASA < = 3
排除标准
- •scoliosis
- •coagulation abnormalities
- •antiplatelet drugs (except ASA)
- •history of back surgery
- •anticipated need of ICU stay
研究组 & 干预措施
LOS group
Patients randomized to recieve epidural catheter placement with LOS technique, without any Rx control
干预措施: LOS (Procedure)
X-ray group
Patients randomized for X-ray placement of epidural catheter
干预措施: X-ray placement (Procedure)
结局指标
主要结局
Incidence of catheters malfunctions in LOS and X-ray group
时间窗: every day until 7th postoperative day
malfunctional catheters are defined as following: * symptomatic hypotension due to epidural infusion * NRS \> 6 in the first postoperative day and NRS \> 4 in subsequent postoperative day * overt malpositioning: * rx evidence of catheter's tip under T10 during routine rx or TC * NRS \> 6 (due to pain at T7-10 dermatomers) with 5 cc/h catheter infusion and response to lidocaine 1% 6ml bolus (low tip) * NRS \> 6 (due to pain at T7-10 dermatomers) with 5 cc/h catheter infusion and NO response to lidocaine 1% 6ml bolus ( not in epidural space or very low tip) * evidence of catheter accidental removal Numerical Rating Scale (NRS) is used to assess pain. Patients self-report actual pain on 0 to 10 scale where 0 is no pain and 10 is the worst immaginable pain.
次要结局
- Evaluate daily pain differences between groups: NRS (Numeric rating scale)(every day until 7th postoperative day)
- Monitoring postoperative surgical complications between groups(at 30th postoperative day)
研究者
Alvise Martini
MD, Principal Investigator
Azienda Ospedaliera Universitaria Integrata Verona