Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block: a Prospective, Randomized, Double-blind, Traditional Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- numerical rating scale (NRS) score in both groups 2 hours after surgery
研究概览
简要总结
- Efficacy of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy
- Safety of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy
详细描述
Scalp nerve block for supratentorial craniotomy patients can effectively reduce the consumption of perioperative analgesic drugs, avoid the occurrence of hypertension and tachycardia, relieve postoperative pain, improve postoperative recovery quality of patients. Scalp nerve block is safe and has fewer complications due to the small amount of local anesthetic. For auriculotemporal nerve block, temporary block of adjacent facial nerve is one of the most likely complications, with an incidence of 8.6%, and usually can be recovered within 24 hours, since the facial nerve was located in the anterior and lower part of the tragus, 1 cm deep in the skin. Therefore, improving nerve block methods and reducing the dosage of local anesthetics may reduce the risk of facial nerve block. The investigators proposed helix feet in front of the zygomatic arch as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood. The study intends to compare a modified auriculotemporal nerve block method with the traditional way, reflecting on perioperative hemodynamical fluctuation, postoperative analgesia effect and incidence of facial nerve paralysis. This will verify the safety and analgesic efficacy of the modified nerve block method proposed in this study, and then provide a basis for improving the quality of perioperative management during neurosurgery.
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, Investigator)
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
- •Patients undergoing supratentorial craniotomy under general anesthesia;
- •18-65 years old;
- •ASA I or II.
排除标准
- •Emergency surgery;
- •Be allergic to ropivacaine;
- •Participating in other clinical investigation within 30 days;
- •Skin infection at the puncture site;
- •Patients taking analgesic drugs before surgery;
- •Persons addicted to alcohol or drugs;
- •Patients with severe liver and kidney dysfunction;
- •Patients with coagulation disorder;
- •Pregnant and lactating women;
- •Patients with consciousness disorder before surgery;
- •Those who have undergone neurosurgery within the last 6 months;
- •Patients who were unable to understand the NRS before surgery.
结局指标
主要结局
numerical rating scale (NRS) score in both groups 2 hours after surgery
时间窗: 2 hours after supratentorial craniotomy
2 hours after supratentorial craniotomy, the participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
numerical rating scale (NRS) score in both groups 8 hours after surgery
时间窗: 8 hours after supratentorial craniotomy
8 hours after supratentorial craniotomy, the participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
numerical rating scale (NRS) score in both groups 24 hours after surgery
时间窗: 24 hours after supratentorial craniotomy
24 hours after supratentorial craniotomy, the participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
incidence of facial paralysis in both two groups
时间窗: within 24 hours after supratentorial craniotomy
within 24 hours after supratentorial craniotomy, the investigators evaluate facial nerve function of awakened participants (Diagnostic criteria for facial paralysis: unable to raise the eyebrows on the same side, unable to frown, unable to close eyes completely, or unable to smile due to facial paralysis on the same side), and record the number of patients who suffer from facial paralysis, and then calculate the incidence as: the number of patient suffering from facial paralysis/the total number in corresponding group
次要结局
- MAP 3 minutes after tracheal intubation(3 minutes after tracheal intubation)
- MAP before nerve block(before nerve block)
- MAP within 10 minutes after nerve block(within 10 minutes after nerve block)
- HR 1 minute after temporal region skin incision(1 minute after temporal region skin incision)
- heart rate (HR) before anesthesia induction(before anesthesia induction)
- MAP 1 minute after temporal region skin incision(1 minute after temporal region skin incision)
- MAP 3 minutes after temporal region skin incision(3 minutes after temporal region skin incision)
- MAP 4 minutes after temporal region skin incision(4 minutes after temporal region skin incision)
- MAP 5 minutes after temporal region skin incision(5 minutes after temporal region skin incision)
- HR within 10 minutes after nerve block(within 10 minutes after nerve block)
- MAP 2 minutes after temporal region skin incision(2 minutes after temporal region skin incision)
- MAP 10 minutes after temporal region skin incision(10 minutes after temporal region skin incision)
- HR 10 minutes after temporal region skin incision(10 minutes after temporal region skin incision)
- HR 30 minutes after temporal region skin incision(30 minutes after temporal region skin incision)
- mean arterial pressure (MAP) before anesthesia induction(before anesthesia induction)
- HR 3 minutes after tracheal intubation(3 minutes after tracheal intubation)
- HR before nerve block(before nerve block)
- MAP 50 minutes after temporal region skin incision(50 minutes after temporal region skin incision)
- HR 50 minutes after temporal region skin incision(50 minutes after temporal region skin incision)
- HR 2 minutes after temporal region skin incision(2 minutes after temporal region skin incision)
- HR 3 minutes after temporal region skin incision(3 minutes after temporal region skin incision)
- MAP 20 minutes after temporal region skin incision(20 minutes after temporal region skin incision)
- MAP 30 minutes after temporal region skin incision(30 minutes after temporal region skin incision)
- MAP 40 minutes after temporal region skin incision(40 minutes after temporal region skin incision)
- HR 40 minutes after temporal region skin incision(40 minutes after temporal region skin incision)
- HR during surgery (at tracheal extubation)(during surgery (at tracheal extubation))
- HR 4 minutes after temporal region skin incision(4 minutes after temporal region skin incision)
- HR 5 minutes after temporal region skin incision(5 minutes after temporal region skin incision)
- HR 20 minutes after temporal region skin incision(20 minutes after temporal region skin incision)
- MAP 1 hour after temporal region skin incision(1 hour after temporal region skin incision)
- MAP during surgery (at tracheal extubation)(during surgery (at tracheal extubation))
- HR 1 hour after temporal region skin incision(1 hour after temporal region skin incision)
研究者
Feng Gao
Director, Principal Investigator, Clinical Professor
Tongji Hospital