Ultrasound-guided Bilateral Two Levels Serratus Anterior Plane Block in Pediatric Cardiac Surgery With Median Sternotomy : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Postoperative Fentanyl consumption
研究概览
简要总结
The serratus anterior plane block (SAPB) is an anterolateral thoracic wall block that was described in 2013 by Blanco et al. who presented it as an alternative to other regional anesthetic techniques. It has been described in adults as an adjunct to general anesthesia or as a primary anesthetic technique for breast surgery, it has not been widely utilized as a primary anesthetic technique in the pediatric population. It was designed to block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax. It provides a viable alternative to paravertebral blockade and central neuraxial block in this patient population The investigators believe that the bilateral two-level injection technique may provide effective analgesia as its efficacy was not properly investigated in corrective heart surgeries with median sternotomy in the pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Risk Adjustment for Congenital Heart Surgery (RACHS) category 1,2 and 3 Pediatric patients undergoing corrective congenital cardiac surgeries via a median sternotomy
排除标准
- •Refusal of legal guardian.
- •Patient with congestive heart failure .
- •Patient undergoing Redo cardiac surgery.
- •Known allergy to local anesthetics.
- •Infection at injection site.
- •Bleeding disorders (drug induced i.e., coumadin; or genetic i.e. hemophilia; or acquired i.e. DIC), coagulopathy: PTT > 40 seconds, INR > 1.4, platelet count < 100x10⁹.
- •severe renal impairment (estimated Glomerular filtration rate less than 30ml/min/1.73m2) or hepatic insufficiency (Child-Pugh Class B and C).
- •Neurological disorders because it will be difficult to assess their pain score (e.g. cerebral palsy).
研究组 & 干预措施
control group
Intraoperative fentanyl without nerve block
SAPB group
bilateral two-level SAPB is performed with the guidance of ultrasound. While the patient is in the supine position with their arms abducted, the US probe is placed in longitudinal plane to visualize and count the ribs down from the clavicle while moving the transducer laterally and distally to identify the muscles overlying the 3rd and 6th ribs at the mid axillary line. Using in- plane approach, a 22-gauge short bevel needle is inserted and advanced to the plane deep to the serratus anterior muscle at the level of 3rd and 6th ribs bilaterally in succession over which a total volume of 1.5ml/kg bupivacaine 0.125% is divided and injected (0.75ml/kg on each side); with total dose not exceeding 2.5 mg/kg.
干预措施: Bilateral two level serratus anterior block (Procedure)
结局指标
主要结局
Postoperative Fentanyl consumption
时间窗: in the first 24 hours post-operatively
次要结局
- Postoperative Face, Leg, Activity, Cry, Consolability "FLACC" pain scale(at 1, 2, 4, 8, 12, and 24 hours post-operatively)
- Time to first rescue analgesia(recorded during the first 24 hours after surgery (in hours unit))
- Time to extubation(24 hours post-operatively)
- Incidence of complications(24 hours post-operatively)
- intraoperative heart rate(Intraoperative period)
- Intraoperative systolic blood pressure(Intraoperative period)
- Intraoperative additional boluses of fentanyl(Intraoperative period)
- Postoperative heart rate(at 1, 2, 4, 8, 12, and 24 hours post-operatively)
- Postoperative systolic blood pressure(at 1, 2, 4, 8, 12, and 24 hours post-operatively)
研究者
Mai Madkour
Associate professor
Cairo University