Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children (RP/MP vs RP)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 主要终点
- Cumulative fentanyl consumption within 24 hours postoperatively
研究概览
简要总结
At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An elective craniotomy under general anesthesia;
- •American Society of Anesthesiologists (ASA) physical status of I or II;
- •Participates with an anticipated fully recovery within 2 hours postoperatively；
- •Informed consent by parent(s) and/or legal guardian.
排除标准
- •History of allergies to any of the study drugs;
- •Excessive alcohol or drug abuse, chronic opioids use (more than 2 weeks or 3 days per week for more than 1 month), or drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids；
- •Psychiatric disorders;
- •Uncontrolled epilepsy;
- •Chronic headache;
- •Peri-incisional infection;
- •Body mass index exceeded the 99th percentile for age;
- •Children who cannot use patient-controlled intravenous analgesia(PCIA) device;
- •Children who cannot understand an instruction of pain scales before surgery.
研究组 & 干预措施
MP plus RP group
Patients in RP/MP group will receive a peri-incisional scalp infiltration with 0.125% methylprednisolone and 0.2% ropivacaine and normal saline miscible liquids. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.
干预措施: Methylprednisolone (Drug)
MP plus RP group
Patients in RP/MP group will receive a peri-incisional scalp infiltration with 0.125% methylprednisolone and 0.2% ropivacaine and normal saline miscible liquids. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.
干预措施: Ropivacaine (Drug)
RP group
Patients in RP group will receive peri-incisional scalp infiltration with 0.2% ropivacaine alone. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Cumulative fentanyl consumption within 24 hours postoperatively
时间窗: Within 24 hours after the operation
The PCIA device provides bolus (0.5µg/kg, 10min lock-out time) and the maximum dose will be limited as 2µg/kg per hour. If the patients feel inadequate analgesia after 5 times of fentanyl bolus, the bolus dose will be increased to 1 µg/kg and the maximum dose will be increased to 4 µg/kg per hour
次要结局
- The number of participants who have no fentanyl consumption(Within 24 hours after the operation)
- The first time to press the patient-controlled intravenous analgesia button(Within 24 hours after the operation)
- The total times that participants press patient-controlled intravenous analgesia button(Within 24 hours after the operation)
- Numeric Rating Scale (NRS)(At 2 hours, 4 hours, 8 hours, 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery)
- Pain control satisfaction score(PCSS)(At 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery)
- length of stay (LOS)(At 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery)
- The occurrence of postoperative nausea and vomiting(The duration of hospitalization after the operation)
- The occurrence of respiratory depression(Within 24 hours after the operation)
- Ramsay Sedation Scale（RSS）(At 2 hours, 4 hours, 8 hours, 24 hours after surgery)
- The time to first water and oral intake request, scales of oral intake after operation(Within 24 hours after the operation)
- Heart rate(During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery)
- Mean arterial pressure(During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery)
- The total consumption of opioids during the operation(During procedure)
- The total consumption of anaesthetic during the operation(During procedure)
- Incisional related adverse events(Within 1 month after surgery)
- The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)(Within 6 month after surgery)
- Emergence delirium(Within 24 hours after the operation)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital