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临床试验/NCT05769309
NCT05769309已完成不适用

Efficacy of Erector Spinae Plane Block on Postoperative Analgesia and Recovery After Off Pump Cardiac Surgery: A Randomised Trial

Menoufia University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年3月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Total intraoperative and postoperative opioid consumption

研究概览

简要总结

In this study the investigators will investigate the efficacy of ESPB as a part of Enhanced recovery after surgery on postoperative analgesia and recovery criteria after off pump cardiac surgery.

详细描述

General anaesthesia will be induced by 0.05 mg/kg midazolam, 3 µg/kg fentanyl, 1-2mg/kg propofol, and 0.5mg/kg of Atracurium. After induction, bilateral erector spinae plane block will be performed in the block group. Intraoperative analgesia will be achieved by fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters. Postoperative analgesia will be managed by paracetamol 1000 mg /6hours and morphine 1-2mg boluses when pain score ≥4 1 to 2 mg to be repeated every 5 minutes if needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-70 years
  • ejection fraction of > 45%
  • undergoing elective off-pump cardiopulmonary bypass surgery

排除标准

  • vertebral anomalies
  • intra-aortic balloon pump in the preoperative period
  • acute myocardial infarction
  • local infection at the site of block
  • allergy to the local anesthetic used
  • morbid obesity, psychiatric disorders, neurologic deficits, alcohol and chronic opioid abuse, and patients with bleeding diathesis.

研究组 & 干预措施

Erector spinae block group

Active Comparator

the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine

干预措施: Erector spinae block (Procedure)

Erector spinae block group

Active Comparator

the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine

干预措施: Fentanyl (Drug)

control group

Other

no block will be done but only IV analgesia.

干预措施: Fentanyl (Drug)

结局指标

主要结局

Total intraoperative and postoperative opioid consumption

时间窗: 48 hours

Microgram and mg

次要结局

  • The heart rate(48 hours)
  • mean arterial blood pressure(48 hours)
  • pain intensity at rest and movement(48 hours)
  • time to extubation(24hours)
  • time to ambulation(24hours)
  • time to oral intake(48 hours)
  • time to first rescue analgesia(24hous)
  • time of chest drain removal(5 days)
  • time of intensive care unit stay(one week)
  • Duration of mechanical ventilation(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amal Gouda Elsayed Safan

lecturer of anaethesia

Menoufia University

研究点 (1)

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