Analgesic Efficacy of Bilateral Ultrasound Guided Transversus Thoracic Muscle Plane Block Versus Erector Spinae Plane Block in Pediatric Patients Undergoing Corrective Cardiac Surgeries - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The total dose of intraoperative fentanyl
研究概览
简要总结
Corrective cardiac surgeries include a bundle of major surgeries that take place in pediatric patients and require imperative perioperative pain control; hence, the art of healing starts from trying to diminish or abolish pain.
The use of highly potent opioids for paediatric cardiac anaesthesia has gained widespread popularity during the last 20 years . In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anaesthetic techniques also blunt the stress response; however, large doses can cause over sedation, respiratory depression and prolonged mechanical ventilation after surgery .
There are many ways to limit pain in such population with the topper potent opioids in the last several years. But new regional pain management modalities started to arise because of their known effect to diminish neuroendocrine stress response, provide excellent postoperative analgesia, and facilitate early postoperative extubation .
Of the new evolving methods, the bilateral Transversus Thoracic Muscle Plane Block (TTPB) provides analgesia to the anterior chest wall and proved to be efficient in pediatric patients undergoing cardiac surgery using a median sternotomy approach .
The bilateral Erector Spinae Plane Block (ESPB) is also one of the recently known pain controlling techniques used in pediatric cardiac surgeries. It became popular because it is much safer and easily administered than other alternative regional techniques as thoracic paravertebral and thoracic epidural block .
详细描述
I. Study design and randomization
Our study will be designed to estimate the analgesic effect of single shot bilatral transversus thoracic muscle plane block compared to that of erector spinae plane block in pediatric patients undergoing corrective cardiac surgeries including atrial septal defect (ASD) repair, ventricular septal defect (VSD) repair, atrioventricular (AV) canal repair, Glenn procedure, Fontan procedure and subaortic membrane resection. Our primary outcome will be the total dose of intra-operative fentanyl boluses.
Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical doctor not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESPB in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesist blinded to the type of block will be responsible for patient management and collecting the intra-operative and postoperative data.
II. Study setting and location
The study will be conducted in the pediatric cardiothoracic operation theatre in Abu El Reesh Pediatric Hospital - Cairo University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical doctor not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESPB in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesist blinded to the type of block will be responsible for patient management and collecting the intra-operative and postoperative data
入排标准
- 年龄范围
- 6 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 2 months - 4 years.
- •ASA II and III.
- •Patients undergoing corrective cardiac surgeries with midline sternotomy incision.
排除标准
- •Patients whose parents or legal guardians refusing to participate.
- •Preoperative mechanical ventilation.
- •Preoperative inotropic drug infusion.
- •Known or suspected coagulopathy.
- •Known or suspected allergy to any of the studied drugs.
- •Severe pulmonary hypertension.
- •Cardiopulmonary bypass time more than 90 minutes.
- •Aortic cross-clamp time more than 45 minutes.
- •Total time from induction till ICU transfer more than 4 hours and 30 mins.
结局指标
主要结局
The total dose of intraoperative fentanyl
时间窗: All through the surgery
Amount of fentanyl required by patients in each group
次要结局
- Pain assessment(Immediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperatively)
- Intra and postoperative haemodynamics including HR and MBP(Intraoperative T1: baseline reading 5 min after intubation, T2: after skin incision, T3: after sternotomy, T4: after aortic cannulation, T5: after weaning from bypass and T6: after skin closure then Immediately after admission to ICU, 1,2,4,8,12 hours)
- Total consumption of Fentanyl during the 1st 12 hours post operatively(Immediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperatively)
- Time (in minutes) to 1st rescue analgesia (Fentanyl) post operatively(First 12 hours postoperatively)
- Time of extubation(First 12 hours postoperatively)
- The incidence of complications(First 12 hours postoperatively)
研究者
Engy I. Abueldahab
Assistant lecturer
Cairo University