Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration for Post-craniotomy Pain
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Total consumption of sufentanil with PCIA device at 48 hours postoperatively.
研究概览
简要总结
Post-craniotomy pain remains a major challenge in patient care following neurosurgery.Flurbiprofen axetil (FA), as an injectable nonselective cyclooxygenase inhibitor, is a widely prescribed NSAID for postoperative 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, thus providing a basis for its local use to achieve efficacy and safety comparable to or greater than systemic administration. In this study, we attempt to evaluate the clinical effects of FA as an adjunct to ropivacaine in pre-emptive scalp infiltration to prevent or reduce pain 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 minimum 18 years;
- •ASA physical status of I - II;
- •Body mass index (BMI) of 15 - 30;
- •Scheduled for supratentorial 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;
- •History of craniotomy or scalp infection;
- •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;
- •Pregnancy and breastfeeding.
研究组 & 干预措施
ropivacaine plus FA
5 mL FA (50 mg; by Beijing Taide Pharmaceutical Co., Ltd) and 15 mL of 1% ropivacaine (Nai Le Pin 10mg/mL; by AstraZeneca AB, Sweden) diluted to a total volume of 30 mL in normal saline
干预措施: FA plus ropivacaine (Drug)
ropivacaine alone
15 mL of 1% ropivacaine diluted to a total volume of 30 mL in normal saline
干预措施: ropivacaine alone (Drug)
结局指标
主要结局
Total consumption of sufentanil with PCIA device at 48 hours postoperatively.
时间窗: at 48 hours postoperatively
A postoperative Patient Controlled Intravenous Analgesia (PCIA) pump containing sufentanil 200μg in 100 mL saline will be administered from admission to the PACU until postoperative 48 hours. The PCIA pump will be set for 0.5 mL bolus doses with a lockout time of 15 min without initial dose or continuous infusion. The maximum dose will be limited to 2 mL (sufentanil 4 μg) per hour.
次要结局
- Pain NRS scores at 1 mon after craniotomy(at 1 mon after craniotomy)
- Total consumption of sufentanil with PCIA pump at 24 hours after craniotomy(at 24 hours postoperatively)
- Pain NRS scores at 4 hours after craniotomy(at 4 hours after craniotomy)
- Pain NRS scores at 48 hours after craniotomy(at 48 hours after craniotomy)
- PONV scores(at 48 hours after surgery)
- Pain NRS scores at 12 hours after craniotomy(at 12 hours after craniotomy)
- Pain NRS scores at 24 hours after craniotomy(at 24 hours after craniotomy)
- Pain NRS scores at 2 hours after craniotomy(at 2 hours after craniotomy)
- Pain NRS scores at 3 mons after craniotomy(at 3 mons after craniotomy)
- Hospital duration after craniotomy(From surgery day until the discharge date from hospital, assessed up to one week)
- Wound healing score(at 3 months after craniotomy)
- Time to first PCIA button press after craniotomy(after craniotomy)
- WHOQOL-BREF score(at 3 months after craniotomy)
- Patient and Observer Scar Assessment Scale(at 3 months after craniotomy)
- The occurrence of other AEs(throughout both the treatment and follow-up periods (up to 3 months))
- The time to first prescription of OC/APAP after craniotomy(up to 48 hours after craniotmy)
研究者
Fang Luo
ProFessor
Beijing Tiantan Hospital