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临床试验/CTRI/2019/07/020429
CTRI/2019/07/020429Other不适用

To study the effect of instillation of intraperitoneal Bupivacaine (0.25%) to achieve postoperative analgesia in patients undergoing Laparoscopic cholecystectomy

Department of anaesthesiology and crtical care1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年11月8日最近更新:

试验速览

阶段
不适用
状态
Other
发起方
入组人数
50
试验地点
1
主要终点
Proportion of patients having Visual Analog Score(VAS)3 at 3hours

研究概览

简要总结

My Thesis is to study the effect of instillation of intraperitoneal Bupivacaine (0.25%) to achieve postoperative analgesia in 50 patients undergoing Laparoscopic Cholecystectomy.  Patients belonging to ASA grade I-II, aged 18year to 60years, weighing between 45-85 Kgs, undergoing Laparoscopic Cholecystectomy under General Anaesthesia are selected for the study.

After removal of gallbladder and haemostasis achieved, residual blood and fluid will be thoroughly suctioned. The surgeon will instill 40ml of 0.25% Bupivacaine in the subdiaphragmatic suprahepatic surface of liver and gall bladder. In the postoperative period, we observe the duration of analgesia using Visual Analog Score, hemodynamic variables, 24 hours analgesic requirement, and any side effects.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I-II Age 18 – 60 years Weight 45-85Kg A patient undergoing Laparoscopic Cholecystectomy under General Anaesthesia.

排除标准

  • Needing bile duct exploration, insertion of a T-drain.
  • Acute cholecystitis.
  • Surgery-related complication example, bile spillage or conversion to open cholecystectomy Duration of surgery exceeded 2 hours.
  • Severe systemic disease.
  • Prolong Analgesics ingestion Allergy to local anesthetics.

结局指标

主要结局

Proportion of patients having Visual Analog Score(VAS)3 at 3hours

时间窗: Proportion of patients having Visual Analog Score(VAS)3 at 3hours

次要结局

  • Duration of analgesia(Haemodynamic Variables such as Heart Rate (HR), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP))

研究者

发起方
Department of anaesthesiology and crtical care
申办方类型
Research institution and hospital

研究点 (1)

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