Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Cumulative morphine consumption
研究概览
简要总结
Postcraniotomy headache (PCH) has been underestimated for the past decades. However, current treatments for PCH are either considered insufficient or accompanied by severe side-effects. Some studies revealed that peri-incisional injection of a mixed cocktail that contains ropivacaine, epinephrine, ketorolac, and methylprednisolone showed significant efficacy in relieving postoperative pain after total hip or knee arthroplasty. Previous literature reported that the cause of PCH was related to incision of the scalp and dura, which is considered similar to causes to postoperative pain after total hip or knee arthroplasty. Thus, investigators suppose that the cocktail mixture can better relieve PCH in adults.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having signed the informed consent,
- •age 18-80 yrs,
- •American Society of Anaesthesiologists (ASA) physical status of I or II,
- •scheduled elective supratentorial craniotomy,
- •planned head fixation in a skull clamp.
排除标准
- •Allergy to LAs,
- •alcohol abuse,
- •intracranial hypertension,
- •active psychiatric disorders,
- •uncontrolled epilepsy,
- •chronic opioid use (more than 2 weeks),
- •undergoing a revision craniotomy,
- •high probability of having postoperative radio- or chemotherapy,
- •expectation of delayed extubation or no planned extubation,
- •pregnancy or breastfeeding during the study,
- •extreme body mass index (BMI) (less than 15 or more than 40),
- •preoperative Glasgow Coma Scale less than 15,
- •undergoing emergency or awake craniotomy surgery,
- •inability to understand the use of the NRS or the PCA. (Patients are informed of the instructions of NRS (from 0 to 10, where 0 and 10 represent no pain and the worst imaginable pain, respectively) and PCA after signing the informed consent the day before the operation. Patients who cannot understand the instruction of NRS and PCA will be excluded from the study.)
结局指标
主要结局
Cumulative morphine consumption
时间窗: 24 hours after recovery
cumulative morphine consumption through PCA within 24 hours after recovery
次要结局
- Total rescue medication usage(within 24 hours after recovery)
- Recovery(an average of 1 month)
- The duration of operation(at the end of the craniotomy)
- Postoperative 0-10 Numeric Rating Score(1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery and 3 and 6 months after craniotomy)
- Time interval to first PCA demand(within 24 hours after recovery)
- Wound Healing Score(3 and 6 weeks after craniotomy)
- The size of surgical incision(at the end of the craniotomy)
- Postoperative antibiotic usage(within 30 days after craniotomy)
- Rate of postoperative complications(within 30 days after craniotomy)
- Rate of post-operative opioid-related side effects(1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery)
- Total PCA press counts(within 24 hours after recovery)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital