Paravertebral Block in Coarctation of the Aorta
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intraoperative fentanyl needs
研究概览
简要总结
Anesthetic management for surgery of aortic coarctation needs special care due to severe pain during lateral thoracotomy incision, the intraoperative hemodynamic instability related to skin incision at lateral thoracotomy, clamping and declamping of the aorta, needs of large doses of analgesia perioperative, needs of vasodilators. Also, postoperative care of the patients after repair is very important issue. The investigators will compare the effect of para-vertebral block with bupivacaine alone or with dexamethasone on Intra and postoperative analgesia.
详细描述
The patients will be divided randomly by sealed envelope into 2 equal groups. Group I (n=30) will receive paravertebral block with 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) and group II (n=30) will receive paravertebral block with 0.5mg/kg 0.25% bupivacaine and 0.1mg/kg dexamethasone.intraoperative fentanyl needs, Intra and postoperative hemodynamics and OPS pain scores will be recorded. Possible risks as hypertension will be treated by nitroglycerin infusion 0.5ug/kg/min or tachycardia (HR more than 20% than baseline) will be managed by additional doses of fentanyl 1-2ug/kg, bradycardia (20% decrease from the baseline) will be managed by atropine 0.02mg/kg. Also, the complications of paravertebral block as peridural and intravascular injection can be avoided by careful aspiration before injection and injection while visualization of the needle by U/S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4m-6 years males and females scheduled for surgery for coarctation of the aorta
排除标准
- •patients with associated other cardiac anomalies (e.g. VSD), patients with airway abnormality, patients with heart failure, patients with endocrine disorders, patients with history of convulsions, neurological disorder, hepatic, renal and neuromuscular diseases, coagulopathy, history of hyperthermia, infection at site of the block and family history of hypersensitivity
研究组 & 干预措施
paravertebral block with bupivacaine
this group will receive 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
干预措施: ultrasound (Device)
paravertebral block with bupivacaine
this group will receive 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
干预措施: paravertebral block (Procedure)
paravertebral block with bupivacaine
this group will receive 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
干预措施: Bupivacaine (Drug)
paravertebral block with bupivacaine
this group will receive 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
干预措施: isotonic saline (Other)
paravertebral block with bupivacaine and dexamethasone
this group will receive 0.5mg/kg bupivacaine 0.25% mixed to 0.1 mg/kg dexamethasone diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
干预措施: Dexamethasone (Drug)
paravertebral block with bupivacaine and dexamethasone
this group will receive 0.5mg/kg bupivacaine 0.25% mixed to 0.1 mg/kg dexamethasone diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
干预措施: ultrasound (Device)
paravertebral block with bupivacaine and dexamethasone
this group will receive 0.5mg/kg bupivacaine 0.25% mixed to 0.1 mg/kg dexamethasone diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
干预措施: paravertebral block (Procedure)
paravertebral block with bupivacaine and dexamethasone
this group will receive 0.5mg/kg bupivacaine 0.25% mixed to 0.1 mg/kg dexamethasone diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Intraoperative fentanyl needs
时间窗: 3hours
total fentanyl consumption intraoperatively
postoperative analgesic requirements
时间窗: 24hours
total narcotic consumption
次要结局
- the first time the analgesic required(24 hours)
- extubation time(24 hours)
研究者
Amany Hassan Saleh
Lecture of anethesia, Cairo university
Cairo University