Analgesia Postoperatoria Mediante Catetere Perdurare e Analgesia Postoperatoria Mediante Infusione Continua Periferia Nell'Intervento Chirurgico Per Riparazione Chirurgica di Aneurismi Dell'Aorta Addominale: Tecniche a Confronto
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Average postoperative pain assessed with numeric rating scale (NRS) in the first 48 hours
研究概览
简要总结
The aim of the study is to determine wether continuous wound infusion with local anaesthetic plus a single dose intravenous morphine is non-inferior to postoperative analgesia provided with continuous thoracic epidural infusion of local anaesthetic plus opiate, in patients undergoing open abdominal aortic aneurism repair.
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
- •Scheduled for elective open aortic aneurism repair
排除标准
- •Patient refusal
- •Platelet count < 80*10^3/mcL
- •International Normalised Ratio > 1.5
- •Other contraindications to the placement of epidural catheter, including ongoing anti platelet or anticoagulant treatment not suspended according to national guidelines
研究组 & 干预措施
Epidural infusion
Thoracic epidural bolus of 10 ml levobupivacaine 0.25% plus sufentanil 0.15 mcg/kg before end of surgery, followed by continuous epidural infusion of 0.12% levobupivacaine plus 0.4 mcg/ml at 5 ml/h infusion rate for 48 hours.
干预措施: Paracetamol (Drug)
Epidural infusion
Thoracic epidural bolus of 10 ml levobupivacaine 0.25% plus sufentanil 0.15 mcg/kg before end of surgery, followed by continuous epidural infusion of 0.12% levobupivacaine plus 0.4 mcg/ml at 5 ml/h infusion rate for 48 hours.
干预措施: Levobupivacaine epidural bolus (Drug)
Epidural infusion
Thoracic epidural bolus of 10 ml levobupivacaine 0.25% plus sufentanil 0.15 mcg/kg before end of surgery, followed by continuous epidural infusion of 0.12% levobupivacaine plus 0.4 mcg/ml at 5 ml/h infusion rate for 48 hours.
干预措施: Sufentanil epidural bolus (Drug)
Epidural infusion
Thoracic epidural bolus of 10 ml levobupivacaine 0.25% plus sufentanil 0.15 mcg/kg before end of surgery, followed by continuous epidural infusion of 0.12% levobupivacaine plus 0.4 mcg/ml at 5 ml/h infusion rate for 48 hours.
干预措施: Epidural catheter placement (Device)
Epidural infusion
Thoracic epidural bolus of 10 ml levobupivacaine 0.25% plus sufentanil 0.15 mcg/kg before end of surgery, followed by continuous epidural infusion of 0.12% levobupivacaine plus 0.4 mcg/ml at 5 ml/h infusion rate for 48 hours.
干预措施: Levobupivacaine plus sufentanil epidural infusion (Drug)
Wound infusion plus morphine bolus
Intravenous slow bolus of 10 mg morphine, wound infiltration with 10 ml levobupivacaine 0.5%, followed by pre-peritoneal continuous wound infusion of levobupivacaine 0.25% at 4 ml/h infusion rate for 48 hours.
干预措施: Paracetamol (Drug)
Wound infusion plus morphine bolus
Intravenous slow bolus of 10 mg morphine, wound infiltration with 10 ml levobupivacaine 0.5%, followed by pre-peritoneal continuous wound infusion of levobupivacaine 0.25% at 4 ml/h infusion rate for 48 hours.
干预措施: Levobupivacaine wound infiltration (Drug)
Wound infusion plus morphine bolus
Intravenous slow bolus of 10 mg morphine, wound infiltration with 10 ml levobupivacaine 0.5%, followed by pre-peritoneal continuous wound infusion of levobupivacaine 0.25% at 4 ml/h infusion rate for 48 hours.
干预措施: Morphine (Drug)
Wound infusion plus morphine bolus
Intravenous slow bolus of 10 mg morphine, wound infiltration with 10 ml levobupivacaine 0.5%, followed by pre-peritoneal continuous wound infusion of levobupivacaine 0.25% at 4 ml/h infusion rate for 48 hours.
干预措施: Wound infusion catheters placement (Device)
Wound infusion plus morphine bolus
Intravenous slow bolus of 10 mg morphine, wound infiltration with 10 ml levobupivacaine 0.5%, followed by pre-peritoneal continuous wound infusion of levobupivacaine 0.25% at 4 ml/h infusion rate for 48 hours.
干预措施: Levobupivacaine wound infusion (Drug)
结局指标
主要结局
Average postoperative pain assessed with numeric rating scale (NRS) in the first 48 hours
时间窗: Average of the NRS recorded at the different time-points (up to 48 hours after emergence from general anaesthesia)
次要结局
- Length of hospital stay(Follow-up of up to 3 months after surgery)
- Number of patients whose urinary catheter was removed at each time-point(0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia)
- Non-invasive blood pressure (mmHg) at each time-point(0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia)
- Incidence of postoperative nausea and vomiting(0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia)
- Number of patients that have restored bowel function at each time-point(0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia)
- Need for rescue doses of morphine at each time-point(0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia)
- Number of patients requiring oxygen administration at each time-point(0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia)
- Number of patients that have restored ability to walk at each time-point(0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia)
- Heart rate (bpm) at each time-point(0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia)
研究者
Paolo Pelosi
Professor
University of Genova