Postoperative Analgesia After Cardiac Surgery: Effects of a Continuous Infusion of Ropivacaine Through Laterosternal Catheters
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.
研究概览
简要总结
This is a prospective double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters inserted at the lateral edges of the sternum will be studied, versus a control group in which normal saline will be infused in the same conditions.
详细描述
Diverse methods for infusion of local anaesthetics after cardiac surgery have been proposed, but none of them provided high-level evidence of efficacy. The catheters studied here are designed for a surgical insertion before closure of the sternotomy, with the aim of infusing the drug the closest possible of the terminations of intercostal nerves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled cardiac surgery.
排除标准
- •- surgery in emergency
- •thoracotomy
- •cardiac graft
- •pregnancy
- •patient's refusal
- •minor or adult under legal protection
- •psychiatric ongoing disease
- •addiction to opiates
- •ongoing opiate treatment
- •inability to use a PCA device
- •respiratory insuffiency (Vital capacity or maximal expired volume per sec. < 50% of the expected value, or mean PAP > 50 mmHg)
- •intra-aortic balloon
- •severe renal insuffiency
- •history of allergy or intolerance to: morphine, acetaminophen, bupivacaine.
研究组 & 干预措施
ropivacaine
干预措施: Ropivacaine (in one arm); catheterization (in both). (Drug)
normal saline
干预措施: Ropivacaine (in one arm); catheterization (in both). (Drug)
结局指标
主要结局
Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.
时间窗: every 4 hours during 48 hours
次要结局
- Number of participants with adverse events(daily during 48 hours)
- Postoperative blood level of ropivacaine at day + 1 and day + 2(daily during 48 hours)
- Pain score at rest, expressed on a visual analogue scale.(every 4 hours during 48 hours)
- Arterial blood gases(every 4 hours during 48 hours)
- Postoperative blood level of troponin(every 8 hours during 48 hours)
- Time to first flatus(daily during 48 hours)
- Morphine consumption on PCA device(every 4 hours during 48 hours)
- Vital capacity and inspiratory reserve volume, related to the preoperative values(daily during 48 hours)
- Signs of intoxication to ropivacaine(eventual reports)