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临床试验/CTRI/2018/02/011763
CTRI/2018/02/011763已完成不适用

Safety and Effectiveness of Bilateral Erector Spinae Plane (ESP) Block in management of Acute Post operative surgical pain in pediatric cardiac surgeries via midline sternotomy.

Department of Cardiac Anesthesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年12月15日最近更新:
适应症

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
To evaluate the assessment of postoperative analgesia by the Modified Objective Pain Score (MOPS) and duration of postoperative analgesia of bilateral erector spinae plane block as compared to standard institutional practices.

研究概览

简要总结

Ultrasound– guided Erector spinae Plane (ESP) block is a novel, yet simpler and promisingregional anesthetic technique for post-operative analgesia that produces anextensive multidermatomal sensory block. The dorsal and ventral rami of thethoracic spinal nerves along with rami communicantes are its site of action.The ESP block, when given bilaterally at the level of   T5 spinous process, provides completeanalgesia from T2-T9 sensory level for about 12 hours on average.  Further, it is less invasive, safer, easierand quicker to perform, with rare to very rare occurrence of complications likepneumothorax. This block results in both somatic andvisceral analgesia3.

  Thus, ESP block could provide adequate andreliable analgesia for all the patients undergoing cardiac surgery via midlinesternotomy. Till date no research has been done regarding the role of ESP blockfor postoperative analgesia in pediatric cardiac surgical patients.

All preoperative cardiacmedication will be continued until the morning of surgery except antiplatelate,anticoagulant drugs. Premedication for children > 5kg will consist of 0.1mg/kg morphine and 0.5 mg/kg promethazine intramuscularly 1 hour before thesurgery. Children <5 kg receive no premedication as per institutionalprotocol. After coming to operative room, initial monitoring will include a5-lead electrocardiogram, Noninvasive blood pressure, and pulse oxymetry.Anesthetic induction will performed with Sevoflurane with oxygen and air, 50%each. Anesthesia will supplemented with intravenous midazolam, 0.05 to 0.1mg/kg; fentanyl 2 mcg/kg and rocuroneum 0.8 mg/kg. The maintenance will beachieved with midazolam, fentanyl, sevoflurane and atracurium as required.

Following measurements will be obtained for each patient. Thehemodynamic parameters – Heart rate and Blood pressure (Systolic, Diastolic andmean) will be measured as baseline, after induction of anaesthesia. Intraoperativemonitoring will be continued. After completion of surgery and administering theblock, hemodynamic parameters noted and patient will be shifted to ICU withendotracheal tube in situ. Extubation time, monitoring of pulse rate, bloodpressure SpO2, ECG, Respiratory rate and Modified objective pain score (MOPS)will be recorded in ICU every 2 hours for 12 hours after surgery.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
6.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • •patients of either sex in the age group of 06 months -12 years, patients with congenital heart disease with normal LV function for elective surgery.

排除标准

  • •emergency surgery, redo surgery, moderate to severe LV dysfunction, bleeding disorder or abnormal coagulation profile, patients planned for thoracotomy.

结局指标

主要结局

To evaluate the assessment of postoperative analgesia by the Modified Objective Pain Score (MOPS) and duration of postoperative analgesia of bilateral erector spinae plane block as compared to standard institutional practices.

时间窗: Modified Objective pain score assessed after extubation and the 2,4,6,8,10,12 hours after extubation

次要结局

  • To compare duration of mechanical ventilation, rescue analgesia (fentanyl) consumption / total opioid consumption and duration of ICU stay.(Extubation time, monitoring of pulse rate, blood pressure SpO2, ECG, Respiratory rate, total fentanyl consumption, duration of mechanical ventilation and duration of ICU stay will be recorded every 2,4,6,8,10 and 12 hours.)

研究者

发起方
Department of Cardiac Anesthesia
申办方类型
Government medical college

研究点 (1)

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