Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery: a Prospective, Double-blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Total intraoperative fentanyl dose
研究概览
简要总结
This study aims to assess the impact of bilateral deep parasternal intercostal plane block on intraoperative opioid consumption in open heart surgery
详细描述
High-dose opioid is associated with various side effects such as nausea, vomiting, urinary retention, and respiratory depression. The neuraxial block (intrathecal, epidural) and peripheral nerve block are regional anesthesia techniques which have the potential to reduce intraoperative opioid consumption. The deep parasternal intercostal plane block is fascial plane block which intended to block anterior cutaneous branch of intercostal nerves.
This study is a double-blind randomized controlled trial. Thirty subjects will be recruited with consecutive sampling method. Eligible subjects with signed informed consent will be randomized into two groups. The first group is the treatment group who will receive bilateral deep parasternal intercostal plane block after induction of anesthesia and the second group will be the control group who will not receive any regional anesthesia. After surgery, extubation time, adverse event (nausea, vomiting), and intensive care unit length of stay will be recorded for both groups.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-70 years old
- •Elective open-heart surgery with median sternotomy approach
排除标准
- •Patient who refuses to participate
- •Patient with local infection in the block area
- •Patient with chronic pain
- •Patient with history of chronic analgesics use
- •Patient who is contraindicated for local anesthetics
- •Patient with cognitive disorder
- •Patient with severe psychiatric disorders
研究组 & 干预措施
deep parasternal plane block
Subjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia.
干预措施: deep parasternal intercostal plane block (Procedure)
deep parasternal plane block
Subjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia.
干预措施: control (Procedure)
control
subjects will receive skin puncture with needle on the same location as the treatment group without administration of local anesthetics after induction of anesthesia,
干预措施: deep parasternal intercostal plane block (Procedure)
control
subjects will receive skin puncture with needle on the same location as the treatment group without administration of local anesthetics after induction of anesthesia,
干预措施: control (Procedure)
结局指标
主要结局
Total intraoperative fentanyl dose
时间窗: intraoperatively
Total intraoperative fentanyl dose will be calculated after surgery
次要结局
- Time to first intraoperative fentanyl(intraoperatively)
- extubation time(Up to 72 hours after surgery)
- opioid side effects(within 24 hours after surgery)
- Intensive care unit length of stay(Up to 7 days after surgery)
研究者
Aida Rosita Tantri
Doctor
Indonesia University