Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- number of patients with success
研究概览
简要总结
Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery. The post-operative pain of this surgery is managed according to recommendation. In the majority of case, femoral nerve block is performed. The femoral nerve block can cause "paralysis" of the quadriceps more or less complete that no allowing a good quadriceps locking. This locking is indispensable to avoid post-operative flexima and to ensure stabilization of the knee during walking.
In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain requires powerful analgesics with their adverse events.
Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in the same time optimal analgesia and optimal quadriceps locking. The main objective of the investigators study is to compare two analgesia techniques : femoral nerve block vs intra articular injection and obturator nerve block in surgery of the anterior cruciate ligament of the knee
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
- •Physical Status score = 1 or Physical Status score = 2
- •Major Patient
- •indication of anterior cruciate ligament reconstruction
- •informed consent for participation in the study
排除标准
- •Contraindication to general analgesia
- •Contraindication to peripheral nerve block
- •Allergy to analgesic treatment
- •Porphyria,
- •Neurologic deficit
- •Contraindication antiinflammatory drugs
- •Simultaneous reconstruction of another ligament or complex gesture intended
- •Patient treated with an anti-arrhythmic drug class III
- •Patient with severe hepatic impairment
- •Pregnant woman
研究组 & 干预措施
femoral nerve block
20 ml injection of 2 mg/ml ropivacaine in femoral nerve
干预措施: Femoral nerve block (Procedure)
obturator nerve block and intraarticular injection
10 ml injection of 2 mg/ml ropivacaine in obturator nerve intraarticular injection : 10 ml of chlorhydrate ropivacaine (2 mg/ml) and 10ml of magnesium sulfate
干预措施: obturator nerve block (Procedure)
obturator nerve block and intraarticular injection
10 ml injection of 2 mg/ml ropivacaine in obturator nerve intraarticular injection : 10 ml of chlorhydrate ropivacaine (2 mg/ml) and 10ml of magnesium sulfate
干预措施: intraarticular injection (Procedure)
结局指标
主要结局
number of patients with success
时间窗: 4 postoperative hours
success is defined by : score chung \> or egal to 9 and quadriceps locking \> or egal to 3/5
次要结局
- Pain for all patients(Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48)
- analgesic consumption for all patients(Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48)
- analgesic adverse events for all patients(Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48)