Effects of Thoracic Paravertebral Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS) - A Randomized, Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative chronic pain scores (VAS) at rest and during mobilization
研究概览
简要总结
Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which is also a predictor of chronic pain. In this study, the investigators aim to compare the postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.
详细描述
Video-assisted thoracoscopic surgeries (VATS) include significant postoperative acute and chronic pain because of trocar site tissue damages, intercostal nerve injuries and related inflammatory responses. Poorly controlled pain in the early postoperative period usually causes chronic pain, and also affects patients' physiotherapy, mobilization and daily function.
Our hypothesis in this study is 'thoracic paravertebral block (TPVB) is associated with an improvement in control of acute and chronic pain after VATS compared to systemic analgesia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •ASA I-III Patients who undergo Video-assisted thoracoscopic surgery (VATS) under GA
排除标准
- •Patients with difficult understanding the instructions for using PCA and/or pain scales Patients with contraindication to regional anesthesia Patients with significant neurologic, psychiatric or cognitive disorders History of substance abuse or chronic opioid use
研究组 & 干预措施
Patient Controlled Analgesia (IV PCA)
Postoperative intravenous (IV) morphine PCA is being used for acute pain control: Basal infusion: 0.3 mg/kg/h Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg
干预措施: Patient Controlled Analgesia (IV PCA) (Drug)
Thoracic Paravertebral Block (TPVB)
Preoperative thoracic paravertebral block (TPVB) at 4 levels from T4 to T8 is being performed and total of 20 mL Bupivacaine 0.5% is deposited (5 mL per level by using landmark technique)
干预措施: Thoracic paravertebral block (TPVB) (Drug)
结局指标
主要结局
Postoperative chronic pain scores (VAS) at rest and during mobilization
时间窗: Up to 6 months
Chronic pain follow-up
次要结局
- Postoperative vital signs(0-48 hours)
- Postoperative acute pain at rest and during coughing/mobilization(0-48 hours)
- Postoperative nausea and vomiting (PONV) and antiemetic requirements(0-48 hours)
- Postoperative morphine consumption(0-48 hours)
- Time to first analgesic(0-48 hours)
- Postoperative first oral intake, flatulence, defecation, mobilization times(0-48 hours)
- Postoperative hospital discharge day and time(Participants is being followed for the duration of hospital stay, an expected average of 1 week)
- Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up(Up to 6 months)
研究者
Nuzhet Mert Senturk, MD, Prof
MD, Prof. Dr
Istanbul University