Does Ultrasound-guided Erector Spinae Plane Block Improve Postoperative Quality of Recovery After Video-assisted Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- the 40-item Quality of Recovery (QoR-40) score
研究概览
简要总结
Video-Assisted Thoracoscopic Surgery (VATS) is a minimally invasive surgery. Despite reduced surgical trauma compared to the traditional thoracotomy approach, pain control after VATS remains challenging. Regional analgesia may be a crucial component of multimodal postoperative pain management. The use of nerve blocks, such as the recently described erector spinae plane block (ESPB) has been shown in case reports to reduce pain and thus has the potential to improve patient recovery. This study aims to test the hypothesis that ultrasound-guided SPB would improve the quality of recovery after VATS by reducing acute postsurgical pain.
详细描述
VATS is a minimally invasive surgical technique to remove intrathoracic lesions. VATS has become increasingly popular and gradually becoming the standard of care for lung surgery. Although acute pain after VATS is less than the traditional thoracotomy, patients still experience moderate amount of pain within the first 24 hours. However, the optimal regional analgesic technique for VATS procedures has not been established.
Thoracic epidural analgesia (TEA) and paravertebral block (PVB) have been tried to improve postoperative analgesia after VATS. Although TEA and PVB provides superior analgesia, these technologies accompanied by the rare but serious complications involving epidural hematoma, pneumothorax and total spinal anesthesia.
Erector spinae plane block (ESPB) is a novel and simple ultrasound-guided regional anesthetic technique, providing analgesia for the ipsilateral hemithorax. Ultrasound guidance is believed to improve peripheral and regional nerve block success rates and safety. ESPB is a technically easy to perform. ESPB has only been reported in case series but so far, no adverse events such as hypotension, hematoma or infection has been reported.
Given its safety, ease of performance and efficacy, the study aims to verify the hypothesis that combines ESPB with general anesthesia would accelerate functional recovery after breast cancer surgery. Our secondary aims were to examine ESPB's effect on analgesic outcomes (e.g., postoperative pain intensity, cumulative opioid consumption, postoperative nausea and vomiting, dizziness, the postanesthesia care unit discharge time and patients' satisfaction) in patients undergoing 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The randomization sequence will be computer generated. Allocation concealment will be carried out via concealed assignments in opaque, sealed, and consecutively numbered envelopes.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists' physical status class of I or II
- •scheduled for elective VATS
排除标准
- •a history of allergy to local anesthetics
- •known coagulation disorders
- •infection near the puncture site
- •chronic opioid use
- •inability to communicate,
- •other reasons that not appropriate for this study.
研究组 & 干预措施
ESPB group
Patient will receive a single shot of Ropivacaine injection 0.5% 25 mL injected at the erector spinae plane.
干预措施: Ropivacaine Injection (Drug)
Control Group
Patient will receive a single shot of normal saline 25 mL injected at the erector spinae plane.
干预措施: Normal saline (Drug)
结局指标
主要结局
the 40-item Quality of Recovery (QoR-40) score
时间窗: The QoR-40 questionnaire was completed by patients at 24 hours after surgery.
QoR-40 incorporates 40 questions assessing 5 dimensions of recovery, including emotional status, physical comfort, psychological support, physical independence, and pain. The global QoR-40 score ranges from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
次要结局
- postoperative pain: numeric rating scale(Acute postoperative pain was assessed using an numeric rating scale (NRS) at 0.5, 1, 2, 4, 8, 12, 24, and 48 hours following video-assisted thoracic surgery.)
- PACU discharge time(Up to 2 hours)
- cumulative opioid consumption(Up to 48 hours after surgery.)
- Incidence of nausea and vomiting(Up to 48 hours)
- patient's satisfaction: numeric rating scale(Patient's satisfaction was evaluated at 48 hours postoperatively.)
- Incidence of dizziness(Up to 48 hours)
研究者
Yao Yusheng
Clinical Professor
Fujian Provincial Hospital