Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time to discharge patient after surgery
研究概览
简要总结
Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy can be performed as outpatient surgery. This approach is difficult in many centers because of post operative pain and nausea/vomiting.
The use of postoperative morphine may be responsible for the state of nausea. The use of ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to have their surgery as an outpatient.
Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was used for the infiltration holes trocar. In recent years, ropivacaine is used for the reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the many publications made on this subject. Its use in the investigators daily surgery, however, has not been evaluated in ambulatory surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Programmed Cholecystectomy
- •Laparoscopy
- •Man and woman
- •ASA 1 or 2
- •Not living alone
- •Patient receiving social security coverage
- •Signature of Informed Consent Form
排除标准
- •Cholecystectomy emergency
- •Patient minor
- •Pregnant woman (pregnancy test) or during breastfeeding
- •Conversion to laparotomy
- •Patient anticoagulant curative dose
- •Living alone
- •Patient addict
- •Peptic Ulcer
- •Refusal to enter the protocol
- •Chronic requiring analgesics long-term
- •Immunosuppression
- •Long-term Treatment with corticosteroids
- •Discovery intraoperative calculation in the bile duct
- •Contraindication to ropivacaine (see cons-indications to ropivacaine)
- •Hypersensitivity to study treatment or concomitant medications anesthesia
- •Cardiac or unbalanced epileptic patients (due to the risk of cardiovascular and neurological local anesthetics)
- •Patients ASA ≥ 3
- •Patient <50 kg
研究组 & 干预措施
standard anesthesia with ropivacaine
ropivacaine
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Time to discharge patient after surgery
时间窗: 6 hours postoperative
次要结局
未报告次要终点