Pre-emptive Topical Lidocaine 5% Plaster for Prevention of Post-craniotomy Pain : a Protocol for a Randomized, Triple Blind, Placebo-controlled Trail
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
Postcraniotomy pain remains a common phenomenon in the neurosurgery field. Managements for postcraniotomy pain are to be standardised and optimized. In the proposed study, the investigators aim to provide a novel regional non-invasive prophylactic strategy for postcraniotomy pain by utilizing Lidocaine 5% plaster.
详细描述
Postcraniotomy pain remains a common phenomenon in the neurosurgery field. Insufficient control of postcraniotomy pain may lead to unexpected clinical outcomes. The current management for postcraniotomy pain mainly involves systemic intravenous or oral medication and regional anaesthetic injection.
The investigators intend to compare pre-emptive lidocaine 5% plaster incision covering to a placebo for prophylaxis of postcraniotomy pain. In the proposed study, the effectiveness and safety of lidocaine 5% plaster for postcraniotomy pain control will be examined compared with those of placebo. The investigators aim to provide a novel regional non-invasive prophylactic strategy for postcraniotomy pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 or older
- •American Society of Anesthesiologists status I or II
- •Registered for elective craniotomy
- •Informed consent for participation in the trial
排除标准
- •Allergy to lidocaine or the hydrogel plaster
- •Chronic headache, craniofacial pain or neuralgia
- •Glasgow Coma Scale less than 15
- •Current or previous cardiovascular or cerebrovascular accident
- •Expected delayed recovery or extubation
- •Uncontrolled arrhythmia
- •History of intracranial operation
- •Emergency or revision craniotomy
- •Mental illness, psychiatric drug use or alcohol abuse
- •Failure to understand the use of a 100 mm VAS or the PCA
研究组 & 干预措施
Lidocaine Patch
Surgeons will be asked to mark the planned incisions site 3 days before craniotomy. The masked Lidocaine 5% patch will be applied to cover the insicion mark as well as the head-holders sites within 6:00 P.M. to 6:00 A.M. for 3 consecutive preoperative days.
干预措施: Lidocaine 5% patch (Drug)
Placebo
Surgeons will be asked to mark the planned incisions site 3 days before craniotomy. The masked placebo patch will be applied to cover the insicion mark as well as the head-holders sites within 6:00 P.M. to 6:00 A.M. for 3 consecutive preoperative days.
干预措施: Placebo patch (Drug)
结局指标
主要结局
Pain intensity
时间窗: 24 hours after craniotomy
Pain intensity will be examined using the 0 - 100 mm visual analogue scale scores, where '0' represents 'no pain' ,and '100' represents 'the most severe pain'.
次要结局
- Pain intensity(1, 4, 6, 12, 48 and 72 hours after craniotomy)
- Time interval to analgesics(0-72 hours after craniotomy)
- Lidocaine 5% plaster safety (systemic)(3 preoperative days)
- Cumulative butorphanol(24, 48 and 72 hours after craniotomy)
- Cumulative intraoperative analgesics consumption(During the craniotomy)
- Length of hospital stay(within 3 months)
- Lidocaine 5% plaster safety (local)(3 preoperative days)
- Pittsburgh Sleep Quality Index (PSQI)(first 3 days after craniotomy.)
研究者
Fang Luo
Clinical Professor
Beijing Tiantan Hospital