Effects of Preoperative Scalp Nerve Block on Postoperative Recovery Quality in Patients Undergoing Excision of Intracranial Meningioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- KPS score
研究概览
简要总结
Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' postoperative recovery quality, which is evaluated by KPS score, peri-operative inflammatory responses, and post-operative pain degree will be evaluated and compared between the two groups.
详细描述
Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' KPS scores at 3d after surgery and at discharge, serum levels of TNF-α、IL-6，IL-1β at 24h after surgery, satisfaction score after recovery, and VAS scores at 1, 2, 3 days post-surgery will be evaluated 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
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old;
- •BMI 18-28 kg/m2;
- •ASA Physical Status 1-2;
- •Clinical diagnosis of primary Meningeoma and will have elective Meningeoma Resection Surgery;
- •With an estimated surgery time of less than 4h;
- •The incision will be conducted at the frontal, top or the temperal skull.
排除标准
- •A history of 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.
结局指标
主要结局
KPS score
时间窗: 7 days post-surgery
Karnofsky performance score (KPS) allows patients to be classified as to their functional impairment. The total scale range is 0-100. The lower the KPS score, the worse the survival for most serious illnesses.
次要结局
- serum TNF-α levels(at 1h and 24h post-surgery)
- Hospitalization Days(up to 30 days)
- out of pocket expenditure for hospitalisation(hospital discharge/up to 30 days)
- pain-relief medications(at 1, 2 and 3 days post-surgery)
- KPS score(3 days post-surgery)
- white blood cell(at 24 h after surgery)
- serum IL-1β levels(at 1h and 24h post-surgery)
- serum levels of CRP(at 24 h after surgery)
- VAS score(at 1, 2 and 3 days post-surgery)
- serum IL-6 levels(at 1h and 24h post-surgery)
- Iowa Satisfaction with Anesthesia Scale (ISAS)(1 hour after the surgery is finished)
- complications(within 30 days after surgery)
研究者
Jie Tian
Principal Investigator
RenJi Hospital