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