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临床试验/CTRI/2025/11/096748
CTRI/2025/11/096748尚未招募不适用

Assessment of efficacy of intravenous lignocaine infusion for postoperative analgesia and quality of recovery compared to intravenous fentanyl in patients undergoing robotic,laproscopic oncosurgeries

Dr Rajasree O1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1)To assess postoperative pain using nrs

研究概览

简要总结

After intubation intravenous lignocaine will be started via a dedicated pump via dedicated line,at a dose of 50mcg/kg/min for 1st hr followed by 25mcg/kg/min for next hour followed 12mcg/kg/min for next 22hrs

Pain will be recorded using NRS at 0,4,8,12,20,24 ,36,72hrs

On postoperative days 2 and 3 ,qor-15 questionnaire will be administered to assess quality of recovery

Patients will also be assessed for postoperative nausea and vomiting and bowel recovery

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA class I and II undergoing robotic and laparoscopic gynaecologic and urologic oncosurgeries under GA 2) Patients who receive intravenous lignocaine infusion as perioperative analgesic.

排除标准

  • Known allergy to lignocaine 2)Intraoperative conversion from minimally invasive to laparotomies 3)Patients with hepatic,renal dysfunction, severe cardiac disease and seizure disorders 4)Inability to comprehend NRS or QoR-15 5)Known allergy to paracetamol and NSAIDs 6)Body weight less than 45 kg.

结局指标

主要结局

1)To assess postoperative pain using nrs

时间窗: 1) for 72hrs postoperatively | 2)2nd and 3rd postoperative day

2)To assess quality of recovery using QoR-15 questionnaire

时间窗: 1) for 72hrs postoperatively | 2)2nd and 3rd postoperative day

3)To assess incidence of PONV and return of bowel function

时间窗: 1) for 72hrs postoperatively | 2)2nd and 3rd postoperative day

次要结局

  • 1) To assess analgesic efficacy of iv lignocaine infusion with another analgesic modality-iv fentanyl(2)Time to discharge from hospital)

研究者

发起方
Dr Rajasree O
申办方类型
Other [other(self)]
责任方
Principal Investigator
主要研究者

Dr Rajasree O

Regional Cancer Centre

研究点 (1)

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