A Prospective Randomized Controlled Trial Evaluating the Efficacy and Safety of Ultrasound-Guided Rhomboid Intercostal and Subserratus Plane Block for Enhanced Recovery After Video-Assisted Thoracoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 24-hour cumulative number of effective PCA presses
研究概览
简要总结
This prospective randomized controlled trial evaluates the efficacy and safety of ultrasound-guided rhomboid intercostal and subserratus plane (RISS) block for postoperative analgesia in patients undergoing video-assisted thoracoscopic surgery (VATS).
Postoperative pain after VATS can impair respiratory function, delay mobilization, and increase opioid consumption. Although several regional anesthesia techniques are available, the optimal analgesic strategy remains under investigation. The RISS block is a novel fascial plane block that may provide effective thoracic analgesia while minimizing opioid-related adverse effects.
A total of 90 adult patients scheduled for elective VATS will be randomly assigned to receive either ultrasound-guided RISS block combined with general anesthesia or general anesthesia alone. The primary outcomes include postoperative 24-hour benefit of analgesia score (BCS) and patient-controlled intravenous analgesia (PCIA) pressing frequency. Secondary outcomes include postoperative pain scores, opioid consumption, and adverse events.
This study aims to determine whether RISS block improves postoperative recovery and reduces opioid requirements after VATS.
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
- Double (Participant, 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
- •Adults aged 18 years or older
- •ASA physical status I-II
- •Scheduled for elective video-assisted thoracoscopic surgery (VATS)
- •Provided written informed consent
排除标准
- •History of shock or coma
- •Coagulopathy
- •Local infection at the puncture site
- •Pre-existing nerve injury on the side intended for block
- •Chronic analgesic use
- •Psychiatric disorders
- •Prior thoracic or breast surgery
- •Allergy to local or general anaesthetic agents
- •Body mass index (BMI) ≥35 kg/m²
- •Inability to operate a patient-controlled analgesia (PCA) device
研究组 & 干预措施
RISS Block Group
干预措施: Rhomboid Intercostal and Subserratus Plane Block with local anesthetic (Procedure)
ICNB Group
干预措施: Intercostal nerve block (Procedure)
Control Group
结局指标
主要结局
24-hour cumulative number of effective PCA presses
时间窗: Within 24 hours postoperatively
Bruggrmann Comfort Scale (BCS) score at 24 hours
时间窗: 24 hours after surgery
次要结局
未报告次要终点
研究者
Lei Shi
Professor
Ningbo University