Effect of Parasternal Plane Block on Intraoperative Nociception in Pediatric Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intraoperative PAM Pain Index
研究概览
简要总结
Effective pain control during pediatric cardiac surgery remains a major clinical challenge, particularly in procedures involving median sternotomy, which is associated with intense nociceptive stimulation. Inadequate intraoperative analgesia may lead to increased opioid requirements, hemodynamic instability, delayed extubation, and prolonged intensive care unit stay. Objective monitoring of nociception may provide valuable information beyond conventional hemodynamic parameters in this vulnerable population.
This prospective randomized controlled study aims to evaluate the effect of ultrasound-guided parasternal plane block on intraoperative nociception in pediatric patients undergoing cardiac surgery with median sternotomy. Intraoperative nociception will be objectively assessed using the Pain Index Monitor (PAM), based on skin conductance measurements.
The results of this study are expected to provide objective evidence regarding the efficacy of parasternal plane block in attenuating nociceptive responses during pediatric cardiac surgery and to support the integration of regional anesthesia techniques and objective nociception monitoring into perioperative pain management strategies for children.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 months and 7 years
- •Scheduled for elective congenital cardiac surgery
- •Planned median sternotomy
- •American Society of Anesthesiologists (ASA) physical status II-III
- •Hemodynamically stable preoperative condition
- •Written informed consent obtained from a parent or legal guardian
排除标准
- •Emergency surgery or redo sternotomy
- •Age <6 months or >7 years
- •ASA physical status I or >III
- •Severe neurological disorders preventing reliable application of behavioral pain scales
- •Failure to obtain written informed consent from a parent or legal guardian
研究组 & 干预措施
Parasternal Plane Block
Patients in this arm will receive standard general anesthesia combined with ultrasound-guided bilateral parasternal plane block. The block will be performed after induction of anesthesia using 0.25% bupivacaine, with a total dose of 1.5 mg/kg, administered in equal volumes to both sides. Intraoperative nociception will be monitored using the Pain Index Monitor (PAM).
干预措施: Parasternal Plane Block (Procedure)
Group without peripheral nerve block
Patients in this arm will receive standard general anesthesia without regional anesthesia techniques. Intraoperative nociception will be monitored using the Pain Index Monitor (PAM).
干预措施: Group without peripheral nerve block (Procedure)
结局指标
主要结局
Intraoperative PAM Pain Index
时间窗: While administering anesthesia during the procedure/surgery
Comparison of intraoperative Pain Index Monitor (PAM) values between groups in pediatric patients undergoing cardiac surgery via median sternotomy. PAM Pain Index values will be recorded at predefined time points, including after induction of anesthesia, after block performance, at skin incision, during sternotomy, and during sternum closure.
次要结局
- Intraoperative Remifentanil Consumption(While administering anesthesia during the procedure/surgery)
- Extubation Time(On the operation day)
研究者
Elif Sule Ozdemir
Principal İnvestigator
Ankara Etlik City Hospital