Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block in Pediatric Patients Undergoing Aortic Coarctectomy , a Randomized Controlled Study .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Total intraoperative fentanyl consumption by mcg/kg.
研究概览
简要总结
Pain is considered to be subjective, however, in children, it is believed to be felt rather than expressed because they often depend on the caregiver for their safety and well-being.
There is significant pain after thoracotomy surgery because of pleural and muscular damage, ribcage disruption, and intercostal nerve damage during surgery, which if not effectively managed, will lead to various systemic complications; pulmonary (atelectasis, pneumonia, and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and tachycardia), musculoskeletal (muscle weakness), increased neurohormonal response and prolonged hospital stay. So adequate and sufficient post-operative analgesia for pediatric patients is mandatory.
The use of highly potent opioids for pediatric cardiothoracic anesthesia has gained widespread popularity during the last 20 years. In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anesthetic techniques also blunt the stress response, However, large doses can cause oversedation, respiratory depression, and prolonged mechanical ventilation after surgery.
serratus anterior plane block guided by ultrasound was developed by Blanco et al, it is a novel technique in the management of pain following thoracic procedures.
Local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the T2 through T9 dermatomes of the anterolateral thorax. It became popular because it is much safer and easily administered than other alternative regional techniques such as thoracic paravertebral and thoracic epidural blocks.
The Erector Spinae Plane Block (ESPB) is also one of the recently known pain-controlling techniques used in pediatric cardiothoracic surgeries. It became popular because it is much safer and easily administered than other alternative regional techniques such as thoracic paravertebral and thoracic epidural blocks. Chin et al. documented the cadaveric spread of local anesthetic and noted that, radiologically, the local anesthetic spread extended 3 or 4 levels cranially and caudally from the site of injection.
These two blocks have been compared in a study by wang HJ et al in patients undergoing radical mastectomy.
To our knowledge, the comparison of serratus Plane Block versus erector spinae plane block in aortic coarctectomy operations in pediatric patients has not been investigated yet. This has encouraged the performance of the present study.
详细描述
comparison between the perioperative analgesic efficacy and any side effects of U/S guided serratus anterior plane block versus the erector spinae plane block in pediatric patients undergoing aortic coarctectomy.
Objectives:
- To calculate the total intraoperative fentanyl (boluses) consumption.
- To assess the need and dose for intra-operative direct vasodilator (Na nitroprusside) after aortic clamping.
- Recording intra-operative and post-operative vital signs including heart rate (HR) and Systolic arterial blood pressure (SBP).
- To calculate total Morphine consumption during the 1st 24 hours postoperatively.
- To evaluate the Time (in minutes) to 1st rescue analgesia (Morphine).
- To assess the degree of pain every 2 hours for the first 24 hours postoperatively by using the pain FLACC score.
- ICU stay time.
Hypothesis We hypothesize that U/S guided serratus anterior plane block will provide as good analgesic effect as ESPB in pediatric patients undergoing aortic coarctectomy.
Ethical Considerations After the approval of the institutional Research Ethics Committee, informed consent will be obtained from the patient's parents or legal guardians prior to the commencement of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 3 months-2 years.
- •RACHS-1 score
- •Patients undergoing aortic coarctectomy operation with Lateral thoracotomy incision.
排除标准
- •Patients whose parents or legal guardians refuse to participate.
- •Preoperative mechanical ventilation.
- •Preoperative inotropic drug infusion.
- •Perioperative cardiopulmonary arrested patients.
- •Patients undergoing aortic coarctectomy operation with midline sternotomy incision.
- •History of mental retardation or delayed development that may interfere with pain intensity assessment.
- •Known or suspected coagulopathy. (PT < 75% of control)
- •Any congenital anomalies or any infection at the site of injection.
- •Known or suspected allergy to any of the studied drugs.
- •liver enzymes elevated more than the normal values.
- •Renal function impairment (Creatinine value more than 1.2mg/dl or BUN more than 20mg/dl).
- •Heart failure patients
- •Redo patients and previous catheter dilatations
结局指标
主要结局
Total intraoperative fentanyl consumption by mcg/kg.
时间窗: Intra-operatively up to extubation
calculating the total dose of fentanyl used intraoperatively
次要结局
- Time (in minutes) to 1st rescue analgesia (morphine)(1st 24 hours postoperatively)
- Heart rate and systolic blood pressure(up to 15 minutes after extubation)
- The need and the dose of sodium nitroprusside after aortic clamping(from aortic clamping until removal of the clamps)
- Face, Legs, Activity, Cry, Consolability (FLACC) score(up to 24 hours after surgery)
- total morphine dose(up to 24 hours after surgery)
- Time (in minutes) to 1st rescue analgesia (morphine)(1st 24 hours postoperatively)
研究者
Ahmed Awad Eissa Roman
Principle investigator
Cairo University