A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Visual analog pain
研究概览
简要总结
Cardiac surgery is associated with pain in the post-operative period. We plan to conduct a study of local anesthetic, ropivacaine, infusion into the sternal wound in adult patients undergoing cardiac surgery to see if it will be safe and result in improved pain control and reduced time to extubation, duration of ICU and hospital stay.
详细描述
Background:
Cardiac surgery is associated with pain in the post-operative period. Recently the ability to infuse local anesthetic drugs into the area of the sternal wound has become available. The studies that have been done thus far have shown efficacy in controlling pain but have been too small to show clinically significant patient outcome differences.
Specific Aim:
We plan to conduct a phase II/III study of local anesthetic infusion into the sternal wound in adult patients undergoing cardiac surgery.
In the Phase II study, 40 patients will be enrolled in a prospective observational open label, dose escalation study of safety and efficacy of local anesthetic infusion into the sternal wound. Outcome measures for efficacy will be visual analog pain (VAP) scores and opioid consumption. Outcome measures for safety will be plasma ropivacaine concentrations and adverse events.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be greater than 18 years of age
- •Be undergoing a cardiac surgical procedure via median sternotomy (i.e., exclude the occasional thoracotomy, since much greater pain with that surgical approach post-operatively)
排除标准
- •Are unable to grant informed consent or comply with study procedure
- •Are undergoing emergency open heart-surgery
- •Allergic to any of the excipients in ropivacaine, propofol, and fentanyl
- •Age < 18 years of age (children have dosing and toxicity concerns)
- •Are pregnant (pregnancy changes pain thresholds)
- •Taking preoperative opioids. (Opioid tolerant patients will require significantly more post-operative opioid use.)
- •Cirrhosis or hepatic failure (may have accumulation of local anesthetic in plasma due to decreased metabolism)
- •Patient receiving lidocaine infusion prior to surgery. (An extremely rare event)
- •Patients having a planned circulatory arrest for their surgical procedure (increased duration of intubation possible)
研究组 & 干预措施
1
Ropivicaine infusion into the sternal wound
干预措施: Ropivacaine (Drug)
2
Normal saline infusion into the sternal wound
干预措施: Normal saline (Drug)
结局指标
主要结局
Visual analog pain
时间窗: 64 hours
次要结局
- infection(64 hours)
- drug toxicity(64 hours)
- narcotic usage(64 hours)