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临床试验/CTRI/2024/07/071224
CTRI/2024/07/071224
尚未招募
不适用

A comparative study of postoperative analgesic effect of intraperitoneal instillation of ropivacaine alone and ropivacaine with dexmedetomidine after laparoscopic cholecystectomy.

Dr Amitha Anna Sajji1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月10日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Dr Amitha Anna Sajji
入组人数
80
试验地点
1
主要终点
To assess the intensity of postoperative pain by visual analogue scale in the first 24

概览

简要总结

Laparoscopic cholecystectomy is currently the most accepted surgical technique for cholelithiasis.Intraperitoneal injections of local anaesthetic are used to minimize postoperative pain after laparoscopic surgery .There are studies available on intraperitoneal instillation of local anaesthetic bupivacaine along with adjuvants for postoperative analgesia following laparoscopy cholecystectomy, but only very few on postoperative analgesia with intraperitoneal instillation of ropivacaine which is a local anaesthetic with an improved safety profile when compared to bupivacaine. Hence my study is performed to compare the postoperative analgesic effect following the intraperitoneal instillation of ropivacaine alone versus ropivacaine plus dexmedetomidine in patients undergoing laparoscopic cholecystectomy. The postoperative pain will be assessed using the VAS score at 0 h, 2 h, 4 h, 6 h, 12 h and 24 h .The secondary outcomes measured are the time to first rescue analgesia and the total analgesics used in first 24 hours as well as incidence of any adverse events.

研究设计

研究类型
Interventional

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 and II Patients 2)Age group of 18-60 years 3)Those patients scheduled for laparoscopic cholecystectomy under general anaesthesia.

排除标准

  • ASA grade III and IV patients 2) History of allergy to study drugs.
  • cardiac pulmonary hepatic or renal disorders 4) Patient refusal 5) Morbid obese patients 6) Pregnant and lactating females 7) Baseline heart rate less than 50 8)Patients needing conversion to open cholecystectomy will be excluded from the final analysis.

结局指标

主要结局

To assess the intensity of postoperative pain by visual analogue scale in the first 24

时间窗: Oh,2h,4h,6h,12h and 24 hour

hours following intraperitoneal instillation of ropivacaine alone versus ropivacaine plus

时间窗: Oh,2h,4h,6h,12h and 24 hour

dexmedetomidine after laparoscopic cholecystectomy.

时间窗: Oh,2h,4h,6h,12h and 24 hour

次要结局

  • To compare the time to first rescue analgesia between the two groups.(24 hours)
  • T0 compare the total dose of analgesic used in the first 24 hours between the two groups.(24 hours)
  • To assess the occurrence of any adverse side effects between the two groups.(24 hours)

研究者

发起方
Dr Amitha Anna Sajji
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Amitha Anna Sajji

Jubilee Mission Medical College and Research Institute

研究点 (1)

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