Echo-guided Scalp Blocks and Incidence of Postoperative Pain in Scheduled Supratentorial Intracranial Surgery.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Intense post-operative pain
研究概览
简要总结
Up to 30% of patients undergoing intracranial surgery present moderate to severe pain. In this type of surgery, the restriction of the pharmacopoeia, which goes against the concept of multimodal analgesia, results in the important use of opioids not without consequences in terms of complications. Numerous studies have highlighted the benefits of scalp blocks in postoperative pain. The originality of this study lies firstly in the fact that the scalp blocks will be guided by ultrasound and secondly, the incidence of severe pain after scalp blocks will be evaluated
详细描述
In neurosurgery, up to 30% of patients experience severe pain (Numeric Pain Rating Scale > 5) after craniotomy. In order to ensure optimal patient comfort during the perioperative period, multimodal analgesia is the rule. However, the use of certain analgesics in this type of surgery is discussed.
The two analgesics most used in this type of surgery are paracetamol and opioids. The latter, used in large quantities, can lead to an increase in drowsiness, disrupt the postoperative neurological clinical examination (Glasgow score, etc.), cause nausea/vomiting or respiratory depression which will increase complications and the length of stay of patients. Despite the use of morphine and its adverse effects, some study highlighted the high incidence of pain, particularly severe pain in post-craniotomy surgery.
Whether it is to improve postoperative pain or to decrease the intraoperative hemodynamic response, many studies have underlined the interest of scalp block in the postoperative analgesia of craniotomies. Even if large randomized clinical trials are necessary, scalp blocks have been evaluated in subdural hematoma evacuation surgeries, in awake neurosurgeries or in Arnold neuralgia. Intraoperative arterial hypertension induces a risk of increased bleeding and an increase in intracranial pressure with the consequent consequences on cerebral perfusion pressure. These hemodynamic variations, whether intra or post operative, are a source of adverse events.
However, the results of the different studies appear to be discordant and are more interested in the comparison of pain scores and not in the incidence of severe pain. Scalp blocks are mostly performed from anatomical landmarks. In addition, the scalp, which is richly vascularized, is a source of intravascular passage of local anesthetics. Ultrasound-guided scalp blocks are part of this morphine-sparing and multimodal analgesia approach and would allow the realization of a locoregional anesthesia by decreasing, through the use of ultrasound, the risks of intravascular injection and the quantity of local anesthetic.
This study is one of the first to evaluate the impact of an ultrasound-guided scalp block on the incidence of severe postoperative pain (Numeric Pain Rating Scale > 4) in supratentorial intracranial 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient managed in the neurosurgical unit for supratentorial intracranial surgery.
- •Person affiliated or beneficiary of a social security plan.
- •Free, informed, and written consent signed by the participant and the investigating physician (at the latest on the day of inclusion and before any examination required by the research).
排除标准
- •Surgical procedure under awake surgery (systematic realization of scalp blocks necessary)
- •Aphasia of comprehension preoperatively or expected postoperatively or any other neurological impairment making self-evaluation of pain impossible.
- •Contraindication to the use of local anesthetics: allergy or history of intoxication to local anesthetics
- •Contraindication to adrenaline infiltration: severe ventricular rhythm disorders, severe obstructive cardiomyopathy, unstable coronary insufficiency, hypersensitivity to adrenaline.
- •Chronic pain patient or patient with daily preoperative consumption of morphine
- •Pregnant or breast-feeding woman
- •Patient under legal protection (persons deprived of liberty or under guardianship)
研究组 & 干预措施
Control group
Patient managed in the neurosurgical unit for supratentorial intracranial surgery randomized in the control group
干预措施: Echo-guided scalp blocks (Drug)
Experimental group
Patient managed in the neurosurgical unit for supratentorial intracranial surgery randomized in the experimental group
干预措施: Classic anesthetic strategy (Drug)
结局指标
主要结局
Intense post-operative pain
时间窗: up to 6 hours after extubation (day 0)
The primary outcome measure will be a composite outcome including: * Either the need to administer morphine titration at a dose greater than 0.05 mg/kg in the immediate postoperative period (i.e., up to 6 hours after extubation). * Either the presence of severe pain defined by an episode of visual analog scale \> 4 in the immediate postoperative period (i.e., up to 6 hours after extubation).
次要结局
- Absolute pain(at Day 0, hourly until 6 hours after extubation and 24 hours after intervention)
- Infection(3 months after Day 0)
- Morphine consumption.(at Day 0, hourly until 6 hours after extubation and 24 hours after intervention)
- Incidence of Postoperative nausea and vomiting(at day 0 : 6 hours and 24 hours after intervention)
- Chronic post-operative pain(3 months after Day 0)