Effect of Nerve Block With Liposome Bupivacaine for Postoperative Pain After Craniotomy: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 主要终点
- Time of first incision pain within 72 hours after surgery
研究概览
简要总结
Acute postoperative pain is a common postoperative adverse reaction. It refers to acute pain that occurs immediately after surgery and usually lasts no longer than 3-7. Among the craniotomy approaches, patients undergoing supratentorial craniotomy with temporal approach had a higher incidence of moderate to severe pain within 24 hours. In the management of postoperative acute pain, multimodal analgesia is recommended. Liposomal bupivacaine was encapsulated by liposomal vesicles and released slowly, lasting up to 72 hours. The long action time also makes the time window of postoperative acute pain completely covered, thus helping patients better control pain. At present, there is an obvious lack of clinical studies on the effectiveness and specific duration of liposome bupivacaine for postoperative acute pain, especially in neurosurgical craniotomy population with transtemporal incision approach, which is a high-risk group for postoperative pain in 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
- Triple (Participant, 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
- 否
入选标准
- •Age 18-65 years old;
- •Patients undergoing craniotomy tumor resection via frontotemporal approach, temporal base approach or temporal occipital approach;
- •ASA grade I ~ III;
- •Sign informed consent.
排除标准
- •Previous history of combined drug allergy;
- •Patients with a history of severe chronic pain;
- •Long-term history of analgesic drug use;
- •Patients with aphasia and other inability to cooperate with the scale were evaluated;
- •Patients with mental system diseases;
- •Patients with incomplete function of vital organs (heart, lung, liver, kidney);
- •History of drug and drug abuse;
- •BMI≥35kg/m2;
- •Pregnant or lactating patients.
研究组 & 干预措施
Liposome bupivacaine group
干预措施: Liposome bupivacaine group (Drug)
Ropivacaine group
干预措施: Ropivacaine group (Drug)
结局指标
主要结局
Time of first incision pain within 72 hours after surgery
时间窗: 72 hours after surgery
次要结局
未报告次要终点
研究者
Ruquan Han
Head of Anesthesiology
Beijing Tiantan Hospital
