Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- duration of anesthesia on sensitivity
研究概览
简要总结
This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5% levobupivacaine and ropivacaine 0.5%.
详细描述
Progress in the practice of anesthesia led to a safety requirement of growing in daily practice. Spinal anesthesia commonly used technique for surgery of the lower limbs, provides a triple neurological lock (sensory, motor and autonomic) of roots of the spinal cord by intrathecal injection of a local anesthetic agent, following the rules of and strict aseptic conditions.
Levobupivacaine and ropivacaine local anesthetic agents are considered less toxic and tend to replace the use of bupivacaine, reference molecule, but the plasma transition is extremely toxic to patients. However, there is currently no study comparing the benefits of levobupivacaine and ropivacaine in isobaric form injected intrathecally for trauma surgery of the lower limbs. We propose to conduct a prospective, randomized double-blind comparison of the use of these two molecules in spinal isobaric form by evaluating the time and duration of action (sensory and motor block), hemodynamic and ventilatory changes (sympathetic block), and the occurrence of any adverse events.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient admitted to the emergency for lower limb trauma,
- •age over 18 years and below 65 years
- •lower limb trauma surgery can be performed under spinal anesthesia.
排除标准
- •Refusal of patients to participate in the study,
- •Patient with cons-indication to spinal anesthesia:
- •Local anesthetic allergy agents (1/13000)
- •bleeding disorders, including pharmacological origin
- •infection at the puncture site,
- •refusal of spinal anesthesia by the patient,
- •Patient trust,
- •Patients whose coagulation is abnormal.
- •Patients with cognitive impairment or incapacitated adult,
- •Multiple trauma,
- •Porphyria,
- •Central preexisting neuropathy,
- •A history of spinal surgery,
- •Epilepsy uncontrolled by treatment,
- •Hypovolemia,
- •Pregnant or lactating women,
- •Participation in another ongoing clinical trial,
- •Patient on anticoagulant therapy,
- •Patient not affiliated with a social security system.
研究组 & 干预措施
ropivacaïne 0,5%,
intrathecal administration of 15mg of ropivacaine 0.5%.
干预措施: ropivacaïne (Drug)
lévobupivacaïne 0,5%
intrathecal administration of 15mg of levobupivacaine 0.5%
干预措施: lévobupivacaïne (Drug)
结局指标
主要结局
duration of anesthesia on sensitivity
时间窗: during 6h after induction
Thermo-algesic exploration of sensitivity through the application of an ice cube
次要结局
- Duration of anesthesia on motor block(during 6h after induction)