Interest of a Bi-truncal Nerve Block (Femoral + Sciatic) Extended, Systematically Associated With General Anesthesia, in the Femoropopliteal Bypass: Study of Post-operative Analgesia and Peripheral Circulation Downstream.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- total morphine consumption
研究概览
简要总结
The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and clonidine in a single dose, performed before induction of general anaesthesia, on analgesia postoperatively assessed by morphine consumption.
Applied to the patient at the beginning of general anesthesia, this technique could allow one hand, to reduce the need for opiates, on the other hand - due to anesthetized limb vasodilation - to improve tissue perfusion downstream.
详细描述
Course of the study Visit 1 (J-15 J-1): Pre-inclusion During a follow-up visit usual pathology, the doctor will propose to the patient to participate in the protocol. Information Form will be given to the patient to be read at home to maintain a sufficient time for reflection.
Visit 2 (J-1): Pre-anesthetic, the eve of the intervention:
During the pre-anesthetic consultation routine, the doctor will check the informed consent and then note the following information on the case report form: age, height, weight, sex of the patient.
Visit 3 (J0): Surgery One hour before surgery the patient will receive premedication with Hydroxyzine (Atarax ®).
Then the anesthetic team install patient in monitoring room so that the test products are administered according to the double-blind randomization schedule prepared in advance. When the block is made, the patient is brought into the operating room for general anesthesia and surgery.
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, Investigator)
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
- •Patients to benefit a planned femoropopliteal bypass through PAOD stage II or III.
- •Aged 18 to 80 years.
- •Having given their consent.
- •Affiliated with a social security scheme.
排除标准
- •Patients with PAOD stage I or IV.
- •Chronic respiratory failure.
- •Severe coronary insufficiency.
- •Renal or hepatic impairment.
- •Patients with chronic pain or preoperative long-term opioid treatment.
- •Patients with cognitive impairment (judged by the investigator) that may interfere with:
- •informed consent,
- •the collection of endpoints,
- •the use of patient-controlled analgesia.
- •Severe abnormality of hemostasis (platelets <80.000 / ml) and / or of coagulation (PT <50%, factor V <50%).
- •Patients with diabetes mellitus and / or diabetic neuropathy.
- •Pregnant or nursing women, women of childbearing age.
- •Refusal of the protocol.
- •Minor or major protected patients.
- •Contraindications to one of the following products:
- •levobupivacaine, clonidine, morphine, paracetamol, nefopam.
- •- Patients with a contra-indication to the administration of sufentanil: hypersensitivity to any component, hypersensitivity to morphine, hypersensitivity to opiates.
研究组 & 干预措施
NaC1
The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and clonidine in a single dose, performed before induction of general anaesthesia, on analgesia postoperatively assessed by morphine consumption.
干预措施: levobupivacaine, clonidine (Drug)
Levobupivacaine + clonidine
The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and clonidine in a single dose, performed before induction of general anaesthesia, on analgesia postoperatively assessed by morphine consumption.
干预措施: levobupivacaine, clonidine (Drug)
结局指标
主要结局
total morphine consumption
时间窗: between hour 0 and hour 0+24h
次要结局
- vomiting(between day 1 and day 30)
- pain score(every 8 hours during the next post-opeartive 48 hours)
- total sufentanil consumption(between induction and extubation)
- rate of reoperation(between day1 and day30)
- sedation score(at hour0+30mn, at hour 0+1h, at hour 0+2h, at H0+4h, at hour 0+8h, at H0+16h, at hour 0+24h)
- Hemodynamic tolerance(between day 1 and day 30)
- nausea(between day 1 and day 30)
- mortality rate(at day 30)
- Bleeding score(between hour 0 and hour 0+24h)
- pain score(every 4 hours during the 24 first post-operative hours)
- total morphine consumption(between Hour 0 and Hour 0+72h)
- pain score at rest(30, 60, 90 and 120 minutes after extubation)