NCT04319588已完成不适用
Parasternal Block for Postoperative Analgesia in Cardiac Surgery: a Pilot Controlled Trial
Campus Bio-Medico University2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2020年3月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Maximum Pain Score
研究概览
简要总结
This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Half of participants will receive General Anesthesia combined to parasternal block while the other half receive only General Anesthesia.
详细描述
60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups:
- Interventional (parasternal group)
- Case control group The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.
The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients undergoing elective cardiac surgery
- •Age over 18 years
- •Approval by the patient of informed consent
排除标准
- •Allergy to local anesthetics
- •Puncture site infection
- •Lack of signing of informed consent
- •Weight <30 Kg
- •Age <18 years
- •Emergency interventions
- •ASA > IV
- •Sternal dehiscences
- •Dementia (for difficulties in managing weaning from mechanical ventilation and pain)
结局指标
主要结局
Maximum Pain Score
时间窗: 24 hours
Postoperative pain assessment using the NRS scale (score from 0 to 10)
次要结局
- Respiratory performance at the TRI-FLOW(24 hours)
- Time to first opioid(48 hours)
- Intraoperative opioid administration(4 hours)
- Total opioids consumption(24 hours)
研究者
Giulia Nonnis
Principal Investigator
Campus Bio-Medico University
研究点 (2)
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