Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- analgesic consumption of level 3 in the two treated groups
研究概览
简要总结
The locoregional anaesthesia is increasingly important in surgical practice, often allowing to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading to a longer hospitalization because of the pain resulting from the surgery. The Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars, showed its efficiency in post-operative analgesia.
Method : realization of a double blind prospective randomized study, control versus placebo Purpose : to show that the local administration of a unique dose of analgesia reduce the post-operative pain with a little or non-invasive technique
详细描述
The study will be done at the department of Obstétric and gynecology, in the CHU of Saint-Etienne. It will include all patients requiring a caesarean without any contraindication.
All the patients requiring a urgent or a very urgent caesarean will be excluded because a rapid consent can't be obtained and the product preparation can't be done.
Inclusion after information and minimum one hour of time for consideration. Randomization : the teatment group will be randomized according to the patient number : control versus placebo : 70 patients in the group infiltration of levobupivacaïne and 70 patients in the group infiltration of a placebo. Every product will be prepared in a 30 ml syringe filled with levobupivacaïne or 0,9 % sodium chloride depending on the group of randomization. All patients will get their caesarean according to the same technique, then, before the cutaneous close, the product will be injected in the caesarean wall.
Fllow-up : supervision of the pain (morphine consumption, VAS) and of undesirable effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •all patients requiring a non-urgent caesarian done according to the Misgav-Ladach technique
排除标准
- •Patients requiring very urgent caesarian
- •allergic to levobupivacaïne
- •with previous history of alcoholism or drug addiction
- •with severe hypotension or an ischemic cardiopathy badly compensated or thyrotoxicoses
- •treated with first generation of IMAO (monoamine oxidase inhibitor) or with anti-arrhytmia drugs with anesthesic activity
研究组 & 干预措施
1
patient who received levobupivacaïne
干预措施: chirocaine (Levobupivacaine) (Drug)
2
patient who received placebo
干预措施: sodium chloride (Drug)
结局指标
主要结局
analgesic consumption of level 3 in the two treated groups
时间窗: 24 hours
次要结局
- visual analogic scale (VAS) at rest or on rising, early rehabilitation, residual pain 2 months after the operation(hours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month)