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临床试验/NCT06701539
NCT06701539尚未招募不适用

Effect of Nerve Block With Liposome Bupivacaine for Postoperative Pain After Craniotomy: A Randomized Control Trial

Beijing Tiantan Hospital0 个研究点目标入组 106 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: Liposome bupivacaine group (Drug)

Ropivacaine group

Active Comparator

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

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruquan Han

Head of Anesthesiology

Beijing Tiantan Hospital

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