Bilateral Erector Spinae Plane (ESP) Catheters Versus Single Shot ESP Block for Open Heart Surgery in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- morphine consumption
研究概览
简要总结
Post operative pain after open heart surgery is still a main concern; current multimodal analgesia modalities have shown good efficacy for postoperative pain at rest, without reaching full pain relief.
The primary goal of this study is to evaluate the effectiveness of peri-operative analgesia, measured by consumption of opioids during the first 48h hours after the surgery, using bilateral erector spinae catheters for 48h, compared to single shot erector spinae block in pediatric patients undergoing open heart surgeries .
详细描述
Fast track to extubation after pediatric cardiothoracic surgery is becoming more common after a number of reports showing it is safe and effective . However, it has introduced new challenges to pain control. Intubated patients require larger doses of opioids and benzodiazepines for comfort . In patients who are awake and spontaneously breathing, pain and agitation cannot be treated with lower doses.
Some centers still administer continuous infusions of opioid and benzodiazepines to extubated patients. These infusions may not be necessary and may even be harmful.
In a pilot study of adult patients undergoing open heart surgery at VinMec hospitals, peri-operative regional analgesia by continuous bilateral erector spinae plane (ESP) block, Investigators showed that the pain relief was efficient and the requirement for opioids in the first 48 hours post-surgery was zero .
It confirmed that the impact of regional anesthesia techniques on main procedure-specific postoperative outcomes is very important in decreasing opioid use in the context of fast-track recovery programs that are recommended after cardiac surgery.
Since April 2017 Investigators are performing bilateral ESP single shot block in cardiac surgery on infants and children. In the post-operative period the patients still need 30 hours after end of surgery small doses opioids to release their pain according to the evaluation by Comfort-B or/and FLACC Scales after the single shot blocks recovered. Since December 2017 Investigators are performing these surgeries with bilateral ESP catheters with an Intermittent infusion of very low doses of local anesthetic according to the guidelines ] in regional anesthesia analgesia in pediatric to improve the post-operative analgesia and avoid any opioids.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded
入排标准
- 年龄范围
- 2 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective open heart surgery
排除标准
- •Consent refusal
- •Urgent surgery
- •unstable hemodynamic patient after anesthesia induction
研究组 & 干预措施
Control Group
Erector spinae bilateral catheters with continuous infusion iso saline during 48h after surgery Day 0 to day 2
干预措施: Continuous infusion of Iso Saline in ESP catheter (Drug)
Regional analgesia group
Erector spinae bilateral catheters with continuous infusion Ropivacaine 0.1 or 0.2%, depending on age, infusion during 48h after surgeryDay 0 to day 2
干预措施: Continuous infusion of ropivacain in ESP catheter (Drug)
结局指标
主要结局
morphine consumption
时间窗: 48 hours after arrival in Intensive care unit
Total consumption of rescue analgesia by morphine (mcg/kg)
次要结局
- pain after extubation at rest(2 hours after extubation at day 1)
- pain after extubation at mobilisation seating in the bed(2 hours after extubation at day 1)
- Persistent pain at 1 month(Consultation 1 month after the surgery)
研究者
Philippe Macaire
Professor in Anesthesiology and Pain
Vinmec Healthcare System