Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
Pain management in patients undergoing neurosurgery is a very important issue. The effectiveness of USG-guided scalp blocks for pain management in craniotomy surgery is currently not known. The purpose of this clinical trial is to evaluate the effectiveness of ultrasound-guided scalp block when performed in patients who undergo supratentorial craniotomies.
详细描述
The main research questions this trial will answer are:
- In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect postoperative pain compared to standard treatment?
- In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect postoperative opioid consumption compared to standard treatment?
- In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect intraoperative haemodynamic parameters (blood pressure and heart rate) compared to standard treatment?
This clinical trial compares ultrasound-guided scalp block with ropivacaine 0.375% versus standard treatment.
The findings of this clinical trial may potentially revolutionise the practice of regional anaesthesia and analgesia in intracranial surgeries. This will lead to better patient outcomes by improving the perioperative care of patients undergoing craniotomy surgery.
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)
盲法说明
Blinding of participants and outcomes assessor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All American Society of Anesthesia class I to III patients undergoing elective supratentorial craniotomies under general anaesthesia.
排除标准
- •Refusal to participate in the study
- •Contraindications to the performance of scalp block, such as local infections
- •Allergy to ropivacaine hydrochloride
- •Age < 18 years old
- •Undergoing emergency craniotomies, posterior fossa surgery, or burr holes surgery
- •Pre-existing chronic pain (defined as persistent or recurrent pain lasting > 3 months)
- •History of drug addiction (illicit substances and opioids use) or chronic alcohol abuse
- •Presence of uncontrolled systemic arterial hypertension, severe cardiovascular disease, severe kidney or severe liver diseases
- •Predicted to require postoperative ventilation in the intensive care unit
- •Psychiatric disorders, serious neurological diseases, or reduced consciousness GCS < 14
结局指标
主要结局
Postoperative pain
时间窗: Pain scores will be measured at 1, 6, 24, and 48 hours after surgery.
Postoperative pain as measured by the visual analogue scale, with no pain being 0 and the maximal pain possible being 10.
次要结局
- Opioid consumption postoperatively(Measured at 24 and 48 hours after surgery)
- Intraoperative blood pressure stability during stimulating points of surgery(Measurements will be made at time 0 (before stimulation), time-1 (1 minute after stimulation), time-3 (3 minutes after stimulation) and time-5 (5 minutes after stimulation).)
- Intraoperative heart rate stability during stimulating points of surgery(Measurements will be made at time 0 (before stimulation), time-1 (1 minute after stimulation), time-3 (3 minutes after stimulation) and time-5 (5 minutes after stimulation).)
研究者
Samuel Ern Hung Tsan
Clinical lecturer
University Malaysia Sarawak