Ultrasound Guided Superficial Cervical Plexus Block for Chronic Pain After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- Chronic pain assessment
研究概览
简要总结
The incidence of postoperative chronic pain after craniotomy is high. Postoperative chronic pain seriously affects patient's quality of life. Compound local scalp nerve block is a good choice for analgesia after craniotomy. However, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block. Superficial cervical plexus block (SCPB) is theoretically promising to solve the analgesia requirements of such surgical approach. At the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture. The purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the incidence of chronic pain after craniotomy via suboccipital retrosigmoid approach.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •Elective suboccipital retrosigmoid approach approach craniotomy;
- •Age between 18 and 65 years;
- •American Society of Anesthesiologists (ASA) physical status I-III.
排除标准
- •The patients or legal clients refuse to provide informed consent;
- •Local infection;
- •Preoperative impairment of consciousness and cognitive function;
- •Uncontrolled hypertension;
- •Inability to communicate;
- •Allergies to experimental drugs;
- •History of drug abuse;
- •History of chronic headache;
- •Aphasia and hearing impairment;
- •Patients undergoing second craniotomy;
- •Body mass index < 18.5 kg/m2 or > 35.0 kg/m2;
结局指标
主要结局
Chronic pain assessment
时间窗: at 3 months after surgery.
Follow-up visit will be conducted by telephone at 3 months after surgery.
次要结局
未报告次要终点
研究者
Yuming Peng
MD,PhD
Beijing Tiantan Hospital