Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Extension of analgesia, assessed in minutes after TAP block
研究概览
简要总结
Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy.
详细描述
In the ultrasound-guided TAP-Block with Dexamethasone group, dexamethasone is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with saline group, saline is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block , after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with intravenously dexamethasone group, dexamethasone is intravenously injected , after Laparoscopic Cholecystectomy. After surgery the extension of postoperative analgesia, incident and rest pain were evaluate in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ASA score I and II
- •age 18 years
排除标准
- •Allergy to local anesthetics
- •Allergy to general anesthetics
- •Allergy or intolerance to acetaminophen
- •Severe renal impairment
- •Severe hepatic impairment
- •Congestive heart failure
- •Coagulation disorders
- •hypoprotidemia
- •Diabetes mellitus History
- •Age greater than 70 years
- •Age below 18 years
- •ASA Physical than 3 Status
- •Lack of informed consent
- •Patients unable to discernment
- •Intolerance to opiates
- •Peptic Ulcer
- •Abuse of alcohol and / or drugs
研究组 & 干预措施
TAP Block and Dexamethasone
After general anesthesia and before the beginning of surgery, 4 mg of Dexamethasone are added to 20 ml of 0,375% Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block.
干预措施: TAP Block and Dexamethasone (Procedure)
TAP Block and Saline
After general anesthesia and before the beginning of surgery, 2 ml of saline are added to 20 ml of 0.375% Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block.
干预措施: TAP Block and saline (Other)
TAP Block and Dexamethasone i.v.
After general anesthesia and before the beginning of surgery, 20 ml of 0,375% Levobupivacaine are used in Ultrasound-guided Tranversus Abdominis Plain Block. In this group 4 mg of dexamethasone are injected intravenously.
干预措施: TAP Block and Dexamethasone i.v. (Drug)
结局指标
主要结局
Extension of analgesia, assessed in minutes after TAP block
时间窗: 24 hours after surgery
After surgery, the extension of analgesia is evaluated in minutes after TAP Block, in the first 24 hours, from operating theatre discharge.
次要结局
- Rest pain, assessed with Visual Analog Scale(24 hours after surgery)
- Incident pain, assessed with Visual Analog Scale(24 hours after surgery)
研究者
Emiliano Petrucci
Doctor
San Salvatore Hospital of L'Aquila