跳至主要内容
临床试验/CTRI/2025/10/096350
CTRI/2025/10/096350尚未招募不适用

Comparison of effects of Scalp Nerve Block versus Local Anaesthetic infiltration on inflammatory response in patients undergoing Craniotomy- A Randomized controlled trial

Bangalore Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月31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
80
试验地点
1
主要终点
To study the effect of Scalp block versus Local infiltration in patients

研究概览

简要总结

Craniotomies are often associated with significant perioperative stress response, leading to alterations in neuro-endocrine hormones and cytokines and hence linked to poor neurological outcomes, increased post-operative complications like mortality and longer intensive care unit and hospital stays. The immune response is influenced by the type of surgery as well as the anaesthetic technique.

 The immune responses can be measured by changes in differential counts, lymphocytes subsets, plasma concentrations of pro-inflammatory cytokines(Interleukin-2, IL-6, IL-12, Interferon-g) and anti-inflammatory cytokines(IL-10, transforming growth factor b) and plasma concentrations of cortisol, epinephrine and nor epinephrine measured before and after surgery.

Neutrophils-to-lymphocyte ratio (NLR) and Platelets-to-lymphocyte ratio (PLR) derived from routine complete blood count tests have emerged as a simple reliable biological marker and cost effective for evaluating systemic inflammation, stress response, and predicting outcome in various surgical populations.

In the context of craniotomy, alterations in NLR and PLR may also serve as surrogate markers for the degree of perioperative stress and inflammation as in various other clinical conditions such as sepsis, cardiovascular diseases and malignancies.

Regional anaesthesia has been speculated to decrease the inflammatory and immunosuppressive responses.Scalp nerve block(SNB) and local anaesthetic infiltration(LI) of the scalp have been proposed to blunt hemodynamic response to craniotomy, reduced anaesthetic requirements, decrease opioid consumption, and reduce postoperative pain perception during craniotomies. In addition, SNB has been shown to attenuate the neuroendocrine stress response by reducing sympathetic activation and inflammatory mediator release. This is probably due to blockade of C-fibres carrying pain and hence reduced activity of sympathetic nerve fibres.

Since there is limited evidence of studies comparing the impact of SNB and LI on post-operative inflammatory response, we intended to study their effect on NLR and PLR 24 & 48 hours post-operatively in patients undergoing craniotomies.

研究设计

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

入排标准

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

入选标准

  • Patients willing to give written informed consent.
  • 2.Patients between the age 18-65 years, undergoing Craniotomy.
  • 3.Patients belonging to ASA physical status I and II.

排除标准

  • Patients posted for re-exploration.

结局指标

主要结局

To study the effect of Scalp block versus Local infiltration in patients

时间窗: Pre-operative CBC | Post-operative 24hours and 48hours CBC

undergoing craniotomies on NLR post- operatively

时间窗: Pre-operative CBC | Post-operative 24hours and 48hours CBC

次要结局

  • To study the effect of Scalp block versus Local infiltration in patients undergoing craniotomies on PLR post-operatively. To study hemodynamic responses, VAS score between 2 groups(Pre-operative CBC)

研究者

发起方
Bangalore Medical College and Research Institute
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Siddalingesh N Hiremath

Bangalore Medical College and Research Institute

研究点 (1)

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