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临床试验/CTRI/2023/07/055799
CTRI/2023/07/055799尚未招募不适用

Comparison of scalp nerve block and local anaesthetic infiltration with local anaesthetic infiltration alone on inflammatory response in patients undergoing elective neurosurgery.

Vardhman Mahavir medical college and Safdarjung hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年7月8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
90
试验地点
1
主要终点
To compare scalp nerve block & local anaesthetic infiltration with local anaesthetic infiltration alone in patients undergoing elective neurosurgery by means of bio markers C-Reactive Protein, Interleukin 6 & Interleukin 10

研究概览

简要总结

This study is randomised ,comparative, prospective ,interventional study where we are comparing effect of scalp nerve block and local anaesthetic infiltration in one group and in other group only the effect of local anaesthetic infiltration alone will be studied on inflammatory response in patients undergoing elective neurosurgery under general anaesthesia by means of bio markers like c reactive protein , interleukin 6 and interleukin 10 as the primary outcome. Secondary outcome will be studied from hemodynamic stability by means of heart rate and blood pressure and comparing postoperative pain by means of visual analog scale.

In this study with this parameters , we are hypothesising that scalp nerve block and local anaesthetic infiltration together are  superior to local anaesthetic infiltration alone in controlling inflammatory response , maintaining hemodynamic stability and relieving postoperative pain.Primarily inflammatory response will be measured  by means of c recative protein , interleukin 6 and interleukin 10  first as baseline then immediately in postoperative period then at 24 hours of surgery  , secondarily hemodynamic stability measured by means of heart rate and blood pressure before anaesthesia induction, 5 minutes after skin incision, during dura opening,at the end of surgery and postoperative pain compared immediately in postoperative period and at 12 hours of surgery.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologists physical status I-II Scheduled for elective neurosurgery.

排除标准

  • Distorted surgical anatomy of Scalp.
  • Previous craniotomy incision.
  • History of allergy to opioids or local anaesthetics.
  • Unable to understand Visual Analog Scale.

结局指标

主要结局

To compare scalp nerve block & local anaesthetic infiltration with local anaesthetic infiltration alone in patients undergoing elective neurosurgery by means of bio markers C-Reactive Protein, Interleukin 6 & Interleukin 10

时间窗: Baseline , Immediately postoperatively & at 24 hours of surgery

次要结局

  • To compare hemodynamic stability by means of heart rate & blood pressure ( mean arterial pressure)
  • To compare the postoperative pain by means of Visual Analog Scale(Immediately postoperative period & at 12 hours of surgery)

研究者

发起方
Vardhman Mahavir medical college and Safdarjung hospital
申办方类型
Government medical college

研究点 (1)

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