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临床试验/NCT00599144
NCT00599144已完成不适用

Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed

Santa Maria alla Gruccia Hospital2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain],

研究概览

简要总结

Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.

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
Triple (Participant, Investigator, 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

入选标准

  • Age>18 years old, ASA 1 and 2
  • Gallbladder adenomatous polyposis and cholelithiasis with no byochemical, clinical and instrumental evidence of acute cholecystitis at the moment of surgery.

排除标准

  • Age<18 years old
  • Pregnancy
  • Previous major surgery of the supramesocholic compartment
  • Acute cholecystitis
  • Choledocolitiasis
  • Acute pancreatitis at the moment of surgery
  • Laparotomic conversion during surgery

结局指标

主要结局

Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain],

时间窗: 6 and 24 hours after surgery

次要结局

  • Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting.(6 and 24 hours)

研究者

发起方
Santa Maria alla Gruccia Hospital
申办方类型
Other

研究点 (2)

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