Combined Preincisional Infiltration and Intraperitoneal Instillation of Levobupivacaine for Postoperative Pain Reduction After Laparoscopic Cholecystectomy; A Double-blind Placebo-controlled Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)
研究概览
简要总结
To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.
详细描述
The primary endpoint of this study was postoperative abdominal pain as measured by a visual analogue scale (VAS), using a VAS lineal with a slide. The patient was asked to indicate a score from 0 to 100 corresponding to his or her pain. At 0.5, 2, 4, 8 and 24 hours after the surgical procedure the primary investigator visited the patient to obtain the VAS scores.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 and 80
- •ASA I or II
- •with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy
排除标准
- •acute cholecystitis, cholangitis, severe acute pancreatitis, advanced liver cirrhosis or suspected gallbladder cancer,
- •a medical history of epilepsy, cardiac arrhythmias or chronic pain of any kind, - allergy to amid type drugs
- •pregnancy
- •patients suffering from hypotension or hypovolemia
- •infectious liver disease
- •conditions obstructing adequate pain scoring
- •patients using drugs that deduce function of the CYP3A4 or CYP1A2 system
- •patients having an American Society of Anaesthesiologists (ASA) classification of three or higher.
研究组 & 干预措施
normal saline
80 mL 0.9% NaCl
干预措施: Levobupivacaine (Drug)
Levobupivacaine
80mL 0.125% levobupivacaine
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)
时间窗: 24 h postoperatively
Postoperative abdominal pain
次要结局
- Shoulder pain(24 h)
- Rescue Analgesics(24 h postoperatively)
- adverse events caused by the investigational procedure or by levobupivacaine itself(Intra- and postoperative up to 24 hours)
- Length of hospital stay(Maximum two weeks)
- intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures(intraoperative, 1 hour)
- postoperative complications during hospitalisation(during hospitalisation (up to two weeks))