Optimal Timing of Parasternal Intercostal Nerve Block Application (Pre-incisional Versus Post-incisional) for Acute Pain Management in Cardiac Surgery; a Randomized Double Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Amount of rescue analgesia
研究概览
简要总结
Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions, and the inability to cough due to median sternotomy. Therefore, duration of mechanical ventilation, length of intensive care unit (ICU) stay, and length of hospital stay of these patients will increase significantly.
many facial plane blocks have been introduced as simple and safe intervention for thoracic wall anesthesia and analgesia. Parasternal intercostal nerve block (PSIB) is a "superficial block" which involves local anesthetic (LA) infiltration in the intercostal space around the sternum where the anterior branches of intercostal nerves exist.
Intraoperative LA administration under direct vision of the surgeon ensures adequate delivery of drugs and minimizes bleeding complication or inadvertent administration in blood vessels. Meanwhile, Preoperative administration of LA guided by ultrasound imaging has been used in variable surgical settings with noticeable success because of preemptive inhibition of noxious stimuli.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 20-70 years,
- •Scheduled to undergo elective cardiac surgeries through median sternotomy involving cardiopulmonary bypass (CPB).
排除标准
- •Patients requiring preoperative inotropes, mechanical ventilation or intra-aortic balloon pump,
- •patients who have previous cardiac surgery,
- •prolonged CPB time (CPB>120 minutes),
- •Intubation time more than 12hrs or planned for overnight ventilation.
- •Allergy to any of used drugs,
- •opioids addiction,
- •Chronic liver disease, chronic renal disease, and cognitive impairment.
结局指标
主要结局
Amount of rescue analgesia
时间窗: 24 hours postoperative
Total amount of opioid administered as rescue analgesia postoperative.
次要结局
- adverse effects(24 hours postoperative)
- intraoperative mean arterial blood pressure (MAP)(during surgery (baseline, at skin incision, at sternotomy, at sternal retraction))
- Intraoperative total fentanyl requirements(during surgery)
- pain score (VAS)(at extubation, 12th, 16th, 20th, and 24th hour postoperative)
- patient satisfaction(28 hours postoperative)
- Intensive Care Unit (ICU) Length of Stay(up to 6 months)
研究者
Samar Rafik Mohamed Amin
lecturer of anesthesia and surgical ICU
Benha University