Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Incidence of chronic pain after chest surgery
研究概览
简要总结
This project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (CPSP) in thoracic postoperative patients. Related clinical characteristics of postoperative chronic pain. The results of the study provide clinicians with a simple and inexpensive new method of preventing CPSP, in order to prevent the occurrence of CPSP and reduce the incidence of CPSP, thereby reducing CPSP to patients and their families, hospitals. And public resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age ≥18 years old, conscious;
- •ASA class Ⅰ ~ Ⅲ;
- •Thoracoscopic lobectomy was proposed;
- •The han nationality;
- •Native speaker of Chinese;
- •Agree to participate in this study and sign the informed consent.
排除标准
- •Patients allergic to meccobalamin or ropivacaine;
- •Patients with previous history of chest surgery;
- •Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture;
- •Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease;
- •Diabetic patients;
- •Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.
结局指标
主要结局
Incidence of chronic pain after chest surgery
时间窗: At the 3rd month after surgery
The incidence of chronic pain after chest surgery was measured by NRS(numeric rating scales) at the 3rd month after surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented "no pain" and a score of 10 represented "worst pain imaginable".
次要结局
- Incidence of postoperative neuropathic pain(At the 3rd month after surgery)
- Cost of stay(At the 3rd month after surgery)
- icu length of stay(At the 3rd month after surgery)
- Incidence of secondary operation(At the 3rd month after surgery)
- Incidence of other postoperative complications(At the 3rd month after surgery)
- The incidence of acute pain after chest surgery(24 to 72 hours after surgery)
- Incidence of readmission within 30 days after surgery(At the 30 days after surgery)
- Incidence of death within 30 days after surgery(At the 30 days after surgery)
- Length of stay(At the 3rd month after surgery)
研究者
Han Yuan
associate chief physician
Xuzhou Medical University