跳至主要内容
临床试验/NCT05539885
NCT05539885尚未招募不适用

Optimal Timing of Parasternal Intercostal Nerve Block in Pediatric Patients Undergoing Cardiac Surgery

Assiut University0 个研究点目标入组 80 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Time to first analgesia request.

研究概览

简要总结

The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block in children undergoing congenital heart surgery is associated with differences in outcomes when compared to ultrasound-guided pre-incisional parasternal block in the form of Pectointercostal fascial plane block (PIFB).

详细描述

Although many studies have found that pre-incisional parasternal block is effective in preventing postoperative sternotomy pain, we found no randomized controlled trials comparing pre-incisional vs post-incisional parasternal block in pediatric patients except for one retrospective cohort study done by Lisa et al comparing surgeon-delivered local anesthetic wound infiltration vs postoperative bilateral Petco-Intercostal Fascial Blocks. The post-incisional parasternal block may give prolonged postoperative pain control (equivalent to analgesia duration of pre-incisional parasternal block plus the duration of the operative procedure.)

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Acyanotic Congenital heart disease; ASD (atrial septal defect), VSD (ventricular septal defect), and CAVC (common atrioventricular canal).
  • Elective open-heart surgery via median sternotomy and under CPB (cardiopulmonary bypass).
  • Hemodynamic stability (no evidence of heart failure, not on vasoactive drugs, and not on mechanical ventilation.

排除标准

  • Previous, urgent, or emergent cardiac surgery. Children with cyanotic congenital heart disease. local infection of the skin at the site of needle puncture, Allergy to bupivacaine, Coagulation disorders, Clinically significant liver or kidney disease, Heart failure or severe pulmonary hypertension.

结局指标

主要结局

Time to first analgesia request.

时间窗: 24 hours

The first analgesic request after extubation

Amount of rescue analgesia.

时间窗: 24 hours

Amount of rescue analgesia (total dose of fentanyl) after extubation.

次要结局

  • Intraoperative fentanyl consumption(time of surgery)
  • Postoperative pain score:(at extubation, 2nd, 6th, 12th, 16th, 20th, and 24th hour after extubation.)

研究者

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

Mohamed Ahmed Ali Ahmed

Consultant of Anesthesia & Pain management, Faculty of Medicine

Assiut University

相似试验