Prospective, Two-center , Randomized, ITT , Parallel Group Evaluating the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pain measured by visual analog scale (VAS)
研究概览
简要总结
Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care.
In order to reduce these postoperative pain, various methods have been evaluated in numerous studies to determine their analgesic role.
As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally administered in the end of surgery to reduce postoperative pain and promote recovery of the patient. In addition, it is also possible to instill the anesthetic directly into the abdominal cavity reducing pain transmitted by nociceptor viscera.
In recent years, new methods have been proposed such as lung recruitment maneuvers and the instillation of saline solution to reduce postoperative pain.
However, no recommendation is on the use of intraperitoneal saline under the management of postoperative pain after laparoscopic cholecystectomy in ambulatory care.
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
- Single (Participant)
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
- •Patient aged 18 to 80 years
- •Patients with biliary pathology requiring cholecystectomy
- •Patients with signed consent
- •Patient eligible to outpatient care
- •No allergy to Naropin
- •Support by laparoscopy
- •Patients affiliated to a social security s
排除标准
- •Contraindications for laparoscopy
- •Contraindications to outpatient surgery
- •Patients with an allergy to paracetamol or tramadol
- •Patient with an addiction to painkillers and / or alcohol
- •Patient with a disease causing chronic pain
- •Patient using analgesics bearing 1 , 2 or 3 chronically
- •Pregnant or breastfeeding women , of reproductive age without effective contraception
- •Minor Patient,
- •Contraindication to surgery,
- •Physical or psychological state does not allow the patient's participation in the study ,
研究组 & 干预措施
Ropivacaine
Ropivacaine 7.5 mg/mL administration
干预措施: Ropivacaine administration (Drug)
Sodium chloride
NaCl 0.9% administration
干预措施: Sodium chloride administration (Drug)
结局指标
主要结局
Pain measured by visual analog scale (VAS)
时间窗: between first postoperative day and 6th postoperative day
次要结局
- global pain measured by BPI (Brief Pain Inventory) scale(30th postoperative day)
- analgesics use(30th postoperative day)
- global morbidity(30th postoperative day)
- specific complications for each treatment(30th postoperative day)