Effects of Scalp Nerve Blocks on Systemic Inflammation After Meningeoma Resection Surgery：a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- serum TNF-α level
研究概览
简要总结
Patients undergoing meningeoma resection surgery will be randomly assigned to two groups. One group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion. Serum levels of TNF-α、IL-6 and IL-1β will be measured and compared at before surgery, 1h, 24h and 72h after surgery, respectively. VAS score, dosage of pain-control medicine and NRS score at the first three days after surgery, ratio of intracranial infection within 30d after surgery, and total hospitalization days and medical expenditure will also be recorded and compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 18-28 kg/m2 ASA Physical Status 1-2 diagnosed Meningeoma and will have selective Meningeoma Resection Surgery the incision will be conducted at the frontal, top or the temperal skull.
排除标准
- •previous brain surgery severe systemic disease (heart, lung, kidney, or immune system) nerval or mental disorders a history of addiction to opioids allergic to ropivacaine infection at block site or severe systemic infection refuse to attend the trial
研究组 & 干预措施
ropivacaine
patients in this group will receive scalp nerve blocks with 0.5% ropivacaine after anesthesia induction and before skull-pin insertion
干预措施: Scalp Nerve Blocks With Ropivacaine (Procedure)
saline
patients in this group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion
干预措施: Scalp Nerve Blocks With Saline (Procedure)
结局指标
主要结局
serum TNF-α level
时间窗: 24 hour after surgery
serum IL-6 level
时间窗: 24 hour after surgery
serum IL-1β level
时间窗: 24 hour after surgery
次要结局
- serum TNF-α level(72 hour after surgery)
- NRS score(72 hour after surgery)
- Hospitalization Days(up to 30 days)
- serum IL-1β level(72 hour after surgery)
- VAS score(72 hour after surgery)
- incidence of intracranial infection(within 30 days after surgery)
- serum IL-6 level(72 hour after surgery)
- dosage of pain-control medicine(within 72 hour after surgery)
- out of pocket expenditure for hospitalisation(hospital discharge/up to 30 days)