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临床试验/NCT04918433
NCT04918433Unknown不适用

Comparison of Pectointercostal Block and Transverse Thoracic Plane Block for ERAS Post Congenital Cardiac Surgery

University of Alexandria1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Weight, height , BMI

研究概览

简要总结

The current study is designed to compare the perioperative analgesic efficacy of transversus thoracis plane block (TTPB) and Pecto-intercostal-fascial plane block (PIFB) in children undergoing cardiac surgery via median sternotomy

详细描述

Sixty paediatric patients of either sex, aged 2-12 years, undergoing elective cardiac surgery via median sternotomy. Patients will be excluded from the current study in case of, refusal to participate, redo or 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, and when extubation is intentionally planned to be delayed. Patients will be randomly assigned to one of two equal groups, the PIF block group and TTP block group, each will include 30 patients, by a computer-generated randomization table and concealed sealed opaque envelopes.

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
Single (Participant)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •either sex, aged 2-12 years, undergoing
  • •elective cardiac surgery via median sternotomy

排除标准

  • •refusal to participate, redo or 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

研究组 & 干预措施

TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB)

Active Comparator

After induction of anaesthesia, ultrasound guided transverses thoracis muscle plane block will be done using 0.25% bupivacaine

干预措施: Regional anaesthesia (Procedure)

PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB)

Active Comparator

After induction of anaesthesia, ultrasound guided pectointercostal facial plane block will be done using 0.25% bupivacaine

干预措施: Regional anaesthesia (Procedure)

结局指标

主要结局

Weight, height , BMI

时间窗: 1 year

Weight in kg and height in cm to allow BMI measurement weight (kg) / height (m2)

Postoperative pain score

时间窗: 1 year

Postoperative pain score at rest, hemodynamic effects, analgesic consumption

次要结局

未报告次要终点

研究者

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

Ibrahim Mabrouk Ibrahim

Assistant lecturer

University of Alexandria

研究点 (1)

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