Ultrasound-Guided Single Shoot Serratus Anterior Plane Block Versus Erector Spinae Plane Block as Novel Techniques for Post-Thoracotomy Pain Control in Pediatric Cardiac Surgery and Its Effect in Ultra-Fast Track Recovery: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Effectiveness of postoperative analgesia
研究概览
简要总结
Background and Objectives: Opioid based analgesia is the main used technique in pediatric cardiac surgery which preclude fast-track recovery. Ultrasound guided regional fascial plane blocks are used recently in many pediatric surgical procedure with excellent outcomes and very low rate of complication. The investigators will compare ultrasound guided serratus anterior plane block and erector spinae plane block in pediatric cardiac surgical procedure through thoracotomy approach regarding effectiveness of postoperative analgesia, incidence of complications and effect in ultrafast track recovery.
Methods: The investigators will enroll 64 pediatric patients aged from 6 months to 10 years undergoing cardiac surgical procedure through thoracotomy approach either with or without cardiopulmonary bypass in this prospective randomized study. After induction of general anesthesia, the patients will be randomly assigned into 2 groups based regional fascial plane block given (SAP group will receive ultrasound guided single shot serratus anterior plane block and ESP group will receive ultrasound guided single shot erector spinae plane block). The effectiveness of postoperative analgesia using FLACC pain score will be recorded as the primary outcome while total consumption of analgesics, the time for rescue analgesia, incidence of complications, and incidence of need for re-intubation will be recorded as the secondary outcomes.
详细描述
INTRODUCTION:
Pain control in pediatric cardiac surgery is an area of great interest with opioid based analgesia is the mainstay used technique. Use of high doses of opioid usually preclude early/ultrafast track recovery and extubation in operating room (OR). The benefits of ultrafast track recovery include shorter intensive care unit (ICU) and hospital stay, lower incidence of postoperative complications, reduce occurrence of ventilator induced complications and infection, with better hemodynamics.
With the era of regional anesthetic techniques, there is an increasing need to use a novel techniques of fascial plane block in pain control post cardiac surgery especially the use of neuraxial blocks carry a great risk of spinal hematoma with use of high doses of heparin.
Ultrasound (U/S) guided serratus anterior plane block (SAPB) and erector spinae plane block (ESPB) are used recently in many thoracic, breast and chest wall surgeries with high success rate, low incidence of complications, and solid pain control with many studies demonstrated superior efficacy in comparison to classic analgesic techniques. The use of SAPB and ESPB in cardiac surgery in general and pediatric cardiac surgery are very limited. Both techniques have been used in pediatric cardiac surgical procedures and provided a promising effect as a simple, safe, and effective postoperative analgesic techniques.
The current study will compare the 2 novel fascial plane blocks -SAPB and ESPB- in pain control and effectiveness for ultrafast track recovery in pediatric cardiac patients undergoing cardiac surgical procedure through thoracotomy approach with or without cardiopulmonary bypass (CBP). The primary outcome will be the effectiveness of postoperative analgesia using FLACC (Face, Leg, Activity, Cry and Consolability) pain score and the secondary outcome will be the total consumption of postoperative analgesics, the time for first rescue analgesia, incidence of complications up to 24 hours, and incidence of need for re-intubation in the first 6 hours.
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, Care Provider)
入排标准
- 年龄范围
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status II-III.
- •Age between 6 months and 10 years old,
- •of both sexes,
- •undergoing cardiac surgical procedure through thoracotomy approach either with or without cardiopulmonary bypass e.g. ASD closure, PDA ligation, and aortic coarctation repair.
排除标准
- •Patients weight less than 5 kg,
- •Patients with coagulopathy,
- •previous cardiac surgery,
- •emergency procedure,
- •previous thoracotomy or sternotomy,
- •surgery through sternotomy incision,
- •patients with complex surgical repair,
- •patients need postoperative mechanical ventilation.
- •hypersensitivity to local anesthetics,
- •infection at site of block injection,
- •parent or guardian refusal.
研究组 & 干预措施
Group serratus anterior plane (SAP)
patients will receive ultrasound guided single shot serratus anterior plane block with 0.5 ml/kg bupivacaine 0.25%
干预措施: Serratus anterior plane block (Procedure)
Group serratus anterior plane (SAP)
patients will receive ultrasound guided single shot serratus anterior plane block with 0.5 ml/kg bupivacaine 0.25%
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
Group erector spinae plane (ESP)
patients will receive ultrasound guided single shot erector spinae plane block with 0.5 ml/kg bupivacaine 0.25%
干预措施: erector spinae plane blocks (Procedure)
Group erector spinae plane (ESP)
patients will receive ultrasound guided single shot erector spinae plane block with 0.5 ml/kg bupivacaine 0.25%
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
结局指标
主要结局
Effectiveness of postoperative analgesia
时间窗: 6 months
We will test the effect of serratus anterior plane block in adequacy of postoperative analgesia (using FLACC pain scale "from 0 to 10") compared to erector spinae plane block
次要结局
- Incidence of complications(6 months)
- Tracheal re-intubation(6 months)
- Length of ICU stay(6 months)
研究者
Akram Mohamed Mohamed Amer
MD
Ain Shams University