The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Systolic arterial pressure response to head pin replacement and skin incision
研究概览
简要总结
This study evaluate the effects of scalp block versus local infiltration on haemodynamic response to head pin replacement and skin incision and postoperative analgesia in posterior fossa surgery
详细描述
In this study 15 patients will receive scalp block with bupivacaine, 15 patients will receive local infiltration with bupivacaine and 15 patients will receive placebo before surgery. The haemodynamic response to head pin replacement and skin incision will be recorded. Postoperatively all patients will have a patient controlled analgesia (PCA) device containing morphine (1 mg/ml) for analgesia. Visual analogue scale (VAS) for pain evaluation, sedation scores, and also postoperative morphine consumption will be evaluated and recorded.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Posterior fossa surgery
- •Preoperative GlasGow Coma Score: 15/15
排除标准
- •Allergy to bupivacaine
- •Uncontrolled hypertension
- •Coagulopathy
- •Cerebrovascular disease
- •Earlier craniotomy
研究组 & 干预措施
scalp block
In this arm, after general anesthesia, before surgery and head pin placement, scalp block will be applied. Scalp block will be performed with bupivacaine (Marcaine 5 mg/mL, 0,5% bupivacaine); nervus supraorbitalis, nervus supratrochlearis, n. auriculotemporalis, nervus zygomaticotemporalis, nervus occipitalis majoris and minoris will be bilaterally blocked with 2-3 ml bupivacaine.
干预措施: Bupivacaine (Drug)
scalp block
In this arm, after general anesthesia, before surgery and head pin placement, scalp block will be applied. Scalp block will be performed with bupivacaine (Marcaine 5 mg/mL, 0,5% bupivacaine); nervus supraorbitalis, nervus supratrochlearis, n. auriculotemporalis, nervus zygomaticotemporalis, nervus occipitalis majoris and minoris will be bilaterally blocked with 2-3 ml bupivacaine.
干预措施: morphine patient controlled analgesia (Drug)
local infiltration
In this arm, after general anesthesia, before surgery, 20 ml 0,5% bupivacaine (Marcaine 5 mg/ml, 0,5% bupivacaine) will be infiltrated to head pin points and skin incision area.
干预措施: Bupivacaine (Drug)
local infiltration
In this arm, after general anesthesia, before surgery, 20 ml 0,5% bupivacaine (Marcaine 5 mg/ml, 0,5% bupivacaine) will be infiltrated to head pin points and skin incision area.
干预措施: morphine patient controlled analgesia (Drug)
control
In this arm, neither scalp block, nor local infiltration will be performed.
干预措施: morphine patient controlled analgesia (Drug)
结局指标
主要结局
Systolic arterial pressure response to head pin replacement and skin incision
时间窗: Intraoperative
Systolic arterial pressures (mmHg) will be recorded in before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
mean arterial pressure response to head pin replacement and skin incision
时间窗: Intraoperative
Mean arterial pressures (mmHg) will be recorded in will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
Heart rate response to head pin replacement and skin incision
时间窗: Intraoperative
heart rates (beats per minute) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
Diastolic arterial pressure response to head pin replacement and skin incision
时间窗: Intraoperative
Diastolic arterial pressures (mmHg) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
次要结局
- postoperative pain(30. minute, 1.,2.,6.,12.,24. hours pain scores (visual analogue score=VAS))
- morphine consumption(30. minute, 1.,2.,6.,12.,24. hours)
研究者
Eren Fatma Akcil
Staff anesthesiologist
Istanbul University