Lecturer of Anesthesia, Intensive Care and Pain Management in Ain Shams University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- effectiveness of perioperative analgesia
研究概览
简要总结
Adequate postoperative pain relief in patients in cardiac surgery is very essential. multimodal techniques for perioperative pain management post cardiac surgery include intravenous patient controlled analgesia, thoracic epidural and paravertebral blockade. Analgesia through thoracic epidural is the gold standard technique for post-sternotomy pain control but it has serious complications. ESP block is an easy technique compared to paravertebral block and less hazardous than thoracic epidural. Hence, this study will compare continuous bilateral erector spinae block guided by ultrasound with intravenous analgesia which is the standard method for pain management in cardiac surgery.
详细描述
Analgesia through thoracic epidural is the gold standard technique for post-sternotomy pain control. in spite of its serious complications such as epidural hematoma with or without paraplegia that enhanced by heparin administered during cardiac bypass surgery..
Paravertebral blockade is comparable to Thoracic epidural analgesia in cardiac surgery but it may cause complications such as vascular injuries and pneumothorax.
Erector spinae block is recently implemented technique for treatment and analgesia of thoracic neuropathic pain and post mastectomy syndrome. ESP block is an easy technique compared to paravertebral block and less hazardous than thoracic epidural.
This study will compare continuous bilateral erector spinae block guided by ultrasound versus intravenous analgesia for pain management in cardiac surgery Patients will be enrolled in the study will be divided into two groups In Group A: 20 patients will receive fentanyl after induction and intubation in the dose of ( 3-52mcg/kg ) according to the patients haemodynamic parameters and the decision of the anaesthesia team at skin incision, before starting Cardiopulmonary bypass and again after bypass and before sternal closure. Once the surgical procedure is finished, patients will be transferred to ICU. After ICU transfer acetaminophen 1 gm/6hrs will be given regularly and NSAID if there is no contraindication after extubation. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation.
In Group B: 20 patients will have bilateral ESP block will be done under general anaesthesia bolus dose 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 8 ml/h starting in ICU for 48 h after extubation. patients will receive intraoperative boluses of fentanyl according to the patients' haemodynamic and the decision of the anaesthesia team at skin incision, before starting Cardiopulmonary bypass and again after bypass and before sternal closure. Once the surgical procedure is finished, patients will be transferred to ICU morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation. Infusion rate will be titrated according to haemodynamics, pain assessment, and complications. After extubation acetaminophen 1gm/6hrs will be given regularly.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective cardiac surgery.
- •age 18-65 years.
- •patients with median sternotomy.
- •body mass index <30kg.m
- •left ventricular ejection fraction >50%.
排除标准
- •significant aortic stenosis.
- •left main coronary artery disease.
- •patient on anti-coagulants0
- •pre-existing respiratory, neurological, or renal disease.
- •CSF or blood tap during the procedure.
- •failure to thread the catheter.
- •anomalies of vertebral column.
研究组 & 干预措施
Narcotics group (group N)
intervention: injection of boluses of intra venous Narcotics (fentanyl) in the dose of (3-5 mcg/kg) during the surgery after induction of anesthesia. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till 48 hours after surgery. NSAID every 12 hrs if there is no contraindication and iv acetaminophine igm/6hrs.
干预措施: intravenous narcotics (Drug)
Erector spinea block group (group B)
intervention: after induction our intervention will be the performance of ultrasound guided bilateral continous Erector spinea block with insertion of catheters then 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 8 ml/h. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation and iv acetaminophine igm/6hrs.
干预措施: continous erector spinea block (Other)
结局指标
主要结局
effectiveness of perioperative analgesia
时间窗: 48 hours after surgery
total dose of perioperative narcotics
次要结局
- extubation time(12 hours after end of surgery)
研究者
Sanaa Farag Mahmoud Wasfy
lecturer of aneathesia
Ain Shams University
