Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery: A Prospective: Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1
研究概览
简要总结
All pediatric patients who undergo cardiac surgery require analgesic medications for postoperative pain control and many require sedation to facilitate comfort with cares. Parasternal infiltration of local anesthetic for nerve blocks is a simple option to postoperative analgesia. The investigators hypothesize that Bupivacaine, a parasternal nerve block administered in pediatric patients undergoing cardiac surgery will reduce the requirement of Opioids and other pain medications as well as decrease postoperative pain scores. This is a prospective, double-blind, randomized controlled trial. Subjects are randomized to receive either 0.25% Bupivacaine or normal saline following their cardiothoracic surgery.
详细描述
One of the most challenging struggles in clinical practices in pediatric cardiac intensive care units is the provision of optimal and safe postoperative analgesia and sedation. All pediatric patients who undergo cardiac surgery require analgesic medications for postoperative pain control and many require sedation to facilitate comfort with cares. Parasternal infiltration of local anesthetic for nerve blocks is a simple option to postoperative analgesia. Bupivacaine is a local anesthetic that can be injected into the intercostal spaces on each side of a sternotomy to induce nerve block.
The purpose of this study is to evaluate whether the use of Bupivacaine as a nerve block in children undergoing cardiothoracic surgery will reduce postoperative pain medication use and decrease postoperative pain scores. The investigators hypothesize that the administration of Bupivacaine bilaterally into the posterior intercostal spaces on each side of a sternotomy following cardiothoracic surgery will reduce the requirement of pain medications as well as decrease postoperative pain scores.
This is a prospective, randomized, double-blind, control study. Subjects are randomized into two arms: those who receive 0.25% Bupivacaine and those who receive placebo (normal saline). Subjects receive 1 milliliter per kilogram up to 20 kilograms, then 0.5 milliliters per kilogram up to 50 kilograms of study drug.
Subjects are followed for 5 days postoperatively, then on day of discharge. Pain medication administered and Face, Legs, Activity, Cry, and Consolability (FLACC) scores are recorded daily for 5 days.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-17 years old at time of surgery
- •Society of Thoracic Surgeons- European Association for Cardio-Thoracic Surgery (STAT) mortality categories 1-3
- •Surgical intervention requiring median sternotomy
- •Expected extubation within 24 hours of surgery
排除标准
- •Known allergic reaction or hypersensitivity to Bupivacaine or to any local anesthetic agent of the amide type
- •Delayed sternum closure
研究组 & 干预措施
Bupivacaine
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
干预措施: Bupivacaine (Drug)
Placebo
Normal Saline
干预措施: Placebo (Drug)
结局指标
主要结局
Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1
时间窗: Day of Surgery and Postoperative Day 1
Total Fentanyl/Equivalent Day 0-1
时间窗: Day of Surgery and Postoperative Day 1
次要结局
- Postoperative Pain Scores-State Behavioral Scale (SBS)(Day of Surgery)
- Postoperative Cortisol Levels(36 hours post-surgery)
- Postoperative Length of Intubation(5 days post cardiac surgery)
- Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale(Day of Surgery)