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临床试验/NCT05475561
NCT05475561已完成2 期

Comparison of Erector Spinae Plane Block and Pecto-Intercostal Facial Plane Block For Enhanced Recovery After Sternotomy in Adult Cardiac Surgery

Alexandria University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月25日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Total dose of fentanyl consumption

研究概览

简要总结

The current study is designed to compare the perioperative analgesic efficacy of Erector spinae plane block (ESPB) and Pecto-intercostal-fascial plane block (PIFB) in adults undergoing cardiac surgery via median sternotomy.

The primary outcome measure will be the analgesic effectiveness of both blocks in median sternotomy pain, while the secondary outcome measures will be time to extubation, and length of intensive care unit stay.

详细描述

The patients will undergo the same preoperative preparation, intraoperative monitoring, and anesthetic technique. Fentanyl (2 μg/kg) will be given with induction of anesthesia, and additional increments of fentanyl 2 μg/kg will be administered if mean arterial blood pressure or heart rate rise in response to stressful surgical stimuli greater than 20% above baseline.

All surgeries will be performed through median sternotomy, with the same cardiopulmonary bypass and myocardial protection technique. At the end of surgery, all anesthetics will be discontinued, and patients will be transferred to the ICU where they will be committed to a mechanical ventilator.

the two blocks will be performed using Linear -Array ultrasound transducer probe (SONOSITE M-TURBO). After standard chest skin disinfection, the transducer will be covered with a sterile sleeve.

he two blocks will be performed using Linear -Array ultrasound transducer probe (SONOSITE M-TURBO). After standard chest skin disinfection, the transducer will be covered with a sterile sleeve.

Ultrasound guided Pecto-intercostal- fascial plane block:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients of either sex
  • aged 18-50 years
  • undergoing elective cardiac surgery via median sternotomy

排除标准

  • refusal to participate,
  • urgent cardiac surgery
  • local infection of the skin at the site of needle puncture
  • allergy to bupivacaine, coagulation disorders
  • clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension
  • extubation is intentionally planned to be delayed.

研究组 & 干预措施

Group (P)

Active Comparator

干预措施: Bupivacain (Drug)

Group (P)

Active Comparator

干预措施: Ultrasound guided Pecto-intercostal- fascial plane block (Procedure)

Group (E)

Active Comparator

干预措施: Ultrasound guided erector spinae plane block (Procedure)

Group (E)

Active Comparator

干预措施: Bupivacain (Drug)

结局指标

主要结局

Total dose of fentanyl consumption

时间窗: after 24 hours postoperative

Analgesic effectiveness of both blocks in median sternotomy pain

次要结局

  • ICU Length of stay(after 48 hour postoperative)
  • time to extubation(after 1 hour of removal of endotracheal tube)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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