Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- The cumulative sufentanil consumption (μg) in PCIA device within 48 hours after craniotomy.
研究概览
简要总结
Post-craniotomy pain is common and often associated with poor outcomes. Flurbiprofen axetil (FA) is an injectable NSAID for postoperative analgesia, however, the impact of local FA, remains elusive on post-craniotomy pain. As FA is highly lipophilic by merging into emulsified lipid microspheres, it has a high affinity to the surgical incision and inflammatory tissues to achieve targeted drug therapy and prolonged duration of action. On base of the previous report that local NSAIDs achieved therapeutic tissue concentrations despite a plasma concentration of <5% of that of systemic administration, a low-dose of FA might be considered a preferential option for local infiltration to avoid anti-platelet related side effects, such as intra-cerebral bleeding. In this study, the investigators attempt to evaluate the clinical effects of pre-emptive scalp infiltration with low-dose FA and ropivacaine for postoperative analgesia after craniotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-64 years;
- •ASA physical status of I - II;
- •Scheduled for craniotomy under general anesthesia;
- •Anticipated tracheal extubation, recovery of consciousness and orientation within 2 hours after craniotomy.
排除标准
- •Glasgow Coma Scale <15;
- •Unable to use the PCIA device or comprehend the pain NRS;
- •History of opioid dependence, chronic headache or intake of any drugs with known analgesic properties within the 24 hours before surgery;
- •Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease;
- •History of allergy to any drug used in the study.
研究组 & 干预措施
Ropivacaine group
0.5% ropivacaine was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder at about 30 min before surgical incision
干预措施: Ropivacaine (Drug)
FA+Ropivacaine group
5mg FA and 0.5% ropivacaine was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder at about 30 min before surgical incision
干预措施: FA+Ropivacaine (Drug)
结局指标
主要结局
The cumulative sufentanil consumption (μg) in PCIA device within 48 hours after craniotomy.
时间窗: within 48 hours after craniotomy
次要结局
未报告次要终点
研究者
Fang Luo
Professor
Beijing Tiantan Hospital