跳至主要内容
临床试验/CTRI/2025/01/079253
CTRI/2025/01/079253
招募中
2 期

Analgesic efficacy of intraperitoneal instillation of dexamethasone and bupivacaine versus bupivacaine in patient undergoing laparoscopic cholecystectomy.

JNMC1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年2月3日最近更新:

概览

阶段
2 期
状态
招募中
发起方
JNMC
入组人数
110
试验地点
1
主要终点
patient receiving dexamethasone 12mg along with bupivacaine 0.25% 4o ml had a significantly longer duration of analgesia

概览

简要总结

After selecting patients on the basis of the inclusion and exclusion criteria posted electively for laparoscopic cholecystectomy will be given Intraperitoneal instillation of injection Dexamethsone 12mg with 0.25% injection Bupivacaine 40ml  is expected to significantly reduces post operative pain and requirment of rescue analgesic compared to 0.25% injection Bupivacaine 40ml alone.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Patients willing to participate in the study ASA grade one to two.
  • Patients undergoing laparoscopic cholecystectomy.

排除标准

  • Patients of age group less than eighteen years and above sixty years.
  • ASA grade three to four.
  • Patients with history of Diabetes mellitus.
  • Patient allergic to the study drug.
  • Pregnant females.
  • Patients with history of previous abdominal surgeries.
  • laparoscopic cholecystectomy got converted to open cholecystectomy.
  • Patients on steroids.

结局指标

主要结局

patient receiving dexamethasone 12mg along with bupivacaine 0.25% 4o ml had a significantly longer duration of analgesia

时间窗: Pre operatively and post operatively - baseline, 1 hourly, 2 hourly, 4 hourly, 8 hourly, 12 hourly, 16 hourly, 24 hourly

次要结局

  • To compare the time of the first rescue.(To compare the time to total rescue analgesic done.)

研究者

发起方
JNMC
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Prachi Kamble

Datta Meghe Institute of Medical Science and research

研究点 (1)

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