The Efficacy of Regional Scalp Block Local Anesthesia as Preemptive Analgesia in Craniotomy Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total opioid consumption
研究概览
简要总结
The objective of this clinical trial is to evaluate the role of scalp nerve block in craniotomy. The primary questions it seeks to answer are: What are the efficacy and safety profiles of scalp nerve block in craniotomy? The anesthesia protocol and monitoring were standardized for all participants. Participants were divided into two groups: the scalp nerve block group and the general anesthesia group. General anesthesia was induced using fentanyl (1-2 mcg/kg), propofol (1-2 mg/kg), and rocuronium (0.6 mg/kg). In the scalp nerve block group, a nerve block was administered using 0.5% ropivacaine.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >18 years
- •American Society of Anesthesiologists (ASA) classification I-III
- •Glasgow Coma Scale (GCS) score ≥ 13
- •Elective craniotomy
排除标准
- •Patients with cardiovascular abnormalities, impaired renal and hepatic function, diabetes mellitus, systemic and/or scalp local infection, and those with a history of current dexamethasone administration
研究组 & 干预措施
Standard Treatment with Scalp Nerve Block
General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Subsequently, scalp nerve block was performed with 0.5% ropivacaine.
During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia.
干预措施: nerve block with 0.5% ropivacaine (Procedure)
Standard Treatment with Scalp Nerve Block
General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Subsequently, scalp nerve block was performed with 0.5% ropivacaine.
During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia.
干预措施: General anesthesia and opioids (fentanyl, propofol, rocuronium) (Drug)
Standard Treatment
General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Then, continuous fentanyl infusion as analgesia maintenance as the standard treatment. During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia.
干预措施: General anesthesia and opioids (fentanyl, propofol, rocuronium) (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: From enrollment until 24 hours post craniotomy surgery.
Opioid used was fentanyl, and it was administered during and post surgery which was measured μg/kg.
次要结局
- Pain Scale(0 to 24 hours after surgery)
- The patients with PONV(0 to 24 hour after surgery)
- Laboratory Markers(After induction of anesthesia, 6 hours after incision, and 24 hours after surgery.)
研究者
Dr. Christijogo Soemartono Waloejo
MD, Ph.D
Universitas Airlangga