Efficacy of Pectointercostal Facial Nerve Block for Postoperative Pain Management After Sternotomy in Pediatric Open Cardiac Surgery:A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-operative pain score
研究概览
简要总结
This randomized, controlled study is designed to assess the quality of analgesia provided by ultrasound-guided bilateral pectointercostal facial block in children undergoing cardiac surgery via midline sternotomy.
详细描述
Following approval from the research and ethics committee ,preoprrative preparation, and induction of anesthesia The patient will be assigned to two equal groups. Conventional control group(C) (n=30) where --- children will not receive any intervention.
Pectointercostal facial group (PI) (n=30) where --children will have bilateral Pectointercostal Block.
Patient positioning and preparation for Ultrasound-guided PIFB After skin disinfection, the PIFB will be performed in a supine position using a high-frequency (6-13 MHz) linear ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA). The probe will be placed at 2 cm lateral from the sternum and parallel to the sternum and will be scanned laterally to identify 4th and 5th costal cartilage The pecto-intercostal fascial plane will be located between the pectoralis major muscle and the external intercostal muscle or the costal cartilage. A 22G, 50 mm peripheral block needle, Stimuplex® Ultra 360 (B. Braun, Melsungen, Germany) will be placed under the pectoralis major and above the external intercostal muscle with an in-plane approach with the ultrasound probe, in a caudal-to-cranial direction until the tip is positioned in the interfascial plane between the PMM and IIM .
A test bolus of saline (1 mL) will be injected to determine that the tip has been placed in the correct fascial layers. Finally, 1.5 mg/kg of 0.2% bupivacaine will be injected into this plane in two locations, over the 2nd and 4th rib. The method on the other side of the PIFB will be the same Care will be taken not to cross the toxic dose of bupivacaine (3 mg/kg). (6) .
Heart rate, mean arterial pressure, and oxygen saturation will be monitored continuously.
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
- 6 Months 至 36 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 6 to 36 months
- •Weight > 5kg
- •Pathology A-V canal , ASD closure, VSD closure surgery through a midline sternotomy.
排除标准
- •Redo patient.
- •History of allergic reactions to local anesthetics.
- •Bleeding disorders with INR > 1.5 and/or platelets < 50
- •Rash or signs of infection at the injection site.
- •Emergency procedures.
结局指标
主要结局
Post-operative pain score
时间窗: At 4 hours.
Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale ( Each category is scored on a 0-2 scale, which results in a total score of 0-10 0:comfortable,1-3:Mild discomfort,4-6:Moderate discomfort, \&7-10:Sever discomfort ) (FLACC) scale pain score at 4 hours.
次要结局
未报告次要终点
研究者
Ahmed Mohamed Mohamed Elhaddad
Lecturer of Anesthesia, ICU and Pain managment
Kasr El Aini Hospital
