Assessing the impact of fast track anesthesia strategies on recovery metrics in pediatric cardiac surgery : A Comparative study between high spinal anesthesia and erector spinae block in conjunction with general anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Duration of supportive mechanical ventilation after completion of surgery.
研究概览
简要总结
Pain after paediatric cardiac surgery is significant. Pain is associated with hemodynamic perturbations, tachyarrhythmias, increase in ventricular afterload, hypertension, pulmonary hypertensive crisis, intermittent right to left shunting, patient-ventilator dysynhroncy, impaired cough, prolonged duration of ventilation, complicate hemostasis,and hypoxia. Pain also has long term adverse effects like bowel failure and neurocognitive dysfunction1.
It is imperative to address pain and achieve good hemodynamic stability in order to wean the patients off the ventilator, mobilize the patients to prevent ventilator associated complications, and good wound healing1.
One of the approaches to addressing pain has been the use of NSAIDS and opioids. Opioids have been the crucial drugs in paediatric cardiac surgeries for intraoperative and post-operative analgesia. Use of high-dose opioids is associated with prolonged post operative recovery period and increased duration of mechanical ventilation, potential increase in ICU stay. Opioids are also associated with somnolence, delirium, disordered breathing, PONV, constipation and urinary retention1.
There has been an increasing interest in regional anesthesia techniques in cardiac surgery for analgesia and the advantages of hemodynamic stability and reducing opioid consumption.
Intrathecal morphine has been safely used for intraoperative and post-operative analgesia without significant adverse effects.2
Spinal anesthesia has been used in paediatric patients since 1899. Spinal anesthesia has been proposed to reduce post-operative apnea, post-operative respiratory dysfunction 3.
Intrathecal bupivacaine combined with intrathecal morphine with general anesthesia in adult patients has been found to reduce stress response and provide stable hemodynamics, although there can be a rare risk of epidural hematoma4.
There have been studies with intrathecal tetracaine with intrathecal morphine in paediatric cardiac surgical patients and found to have reduced stress responses, facilitating early extubation5.
ESP blocks have been described for pain management in thoracic surgeries and cardiac surgeries.It has advantages of being safer and simpler than thoracic epidural, paravertebral blocks6.
Local anesthesia drugs given in ESP block have limited duration of action, in order to prolong duration of analgesia Dexmedetomidine is added, which is selective alpha-2 agonist. Dexmedetomidine as an adjuvant provides effective and safe analgesia8.
The rationale for this study lies in the fact that there have been fewer studies of high spinal anesthesia using intrathecal hyperbaric bupivacaine with intrathecal morphine and bilateral ESP block in paediatric cardiac surgical patients for assessing fast tracking. Considering the large number of paediatric patients coming for cardiac surgery, with this knowledge gap we intend to compare impact of high spinal anesthesia and ESP block with general anesthesia for fast tracking in paediatric cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •1Acyanotic heart disease: ASD closure, VSD closure, without severe PAH with midline sternotomy.
- •2.ASA I –III.
排除标准
- •1.Emergency cases.
- •2.Active respiratory infections.
- •3.Patients with contraindication to spinal anesthesia or erector spinae block.
- •4.History of allergies to local anesthetics.
- •5.Pre existing neurological or spinal disorders.
- •• Redo cardiac surgery.
- •• Severe Left ventricular dysfunction.
- •• Severe PAH.
结局指标
主要结局
Duration of supportive mechanical ventilation after completion of surgery.
时间窗: Primary outcome will be measured from completion of surgery, every hourly till the patients gets extubated.
次要结局
- 6To assess the post-operative fentanyl requirement.(•Quality of analgesia using MOPS score.)
研究者
V M Vishwanath
PGIMER
