Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery
2020年1月1日 更新者：Han Yuan、Xuzhou Medical University
Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial
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.
研究概览
研究类型
介入性
注册 (预期的)
124
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Jiangsu
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Xuzhou、Jiangsu、中国、225000
- Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：ropivacaine combined with mecobalamine
Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).
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In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity.
5ml was injected into each intercostal nerve block.
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有源比较器：ropivacaine
Intercostal nerve block with 0.5% ropivacaine alone.
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In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity.
5ml was injected into each intercostal nerve block.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of chronic pain after chest surgery
大体时间：At the 3rd month after surgery
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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".
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At the 3rd month after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The incidence of acute pain after chest surgery
大体时间：24 to 72 hours after surgery
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An NRS score was performed 24 to 72 hours after surgery to determine the incidence of acute pain after thoracic 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".
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24 to 72 hours after surgery
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Incidence of postoperative neuropathic pain
大体时间：At the 3rd month after surgery
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The incidence of neuropathic pain was measured by DN4 scale at the 3rd month after surgery.Douleur Neuropathique 4 (DN4) is a screening questionnaire to help identify neuropathic pain (NP) in clinical practice and research,where a DN4 scores greater than or equal to 4 represented the patients had "postoperative neuropathic pain".
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At the 3rd month after surgery
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Incidence of other postoperative complications
大体时间：At the 3rd month after surgery
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Postoperative complications included that pulmonary complications, delirium, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, incision infection, cerebrovascular accident and other complications related to surgery.
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At the 3rd month after surgery
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Incidence of readmission within 30 days after surgery
大体时间：At the 30 days after surgery
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The incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up.
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At the 30 days after surgery
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Incidence of death within 30 days after surgery
大体时间：At the 30 days after surgery
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The incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up
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At the 30 days after surgery
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Length of stay
大体时间：At the 3rd month after surgery
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The total length of hospital stay.
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At the 3rd month after surgery
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Cost of stay
大体时间：At the 3rd month after surgery
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The total cost of hospital stay.
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At the 3rd month after surgery
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icu length of stay
大体时间：At the 3rd month after surgery
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The number of hours of postoperative stay in ICU.
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At the 3rd month after surgery
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Incidence of secondary operation
大体时间：At the 3rd month after surgery
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Whether the patient has a second operation and the reason and the incidence of this operation.
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At the 3rd month after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年1月1日
初级完成 (预期的)
2020年6月30日
研究完成 (预期的)
2020年11月30日
研究注册日期
首次提交
2019年11月30日
首先提交符合 QC 标准的
2020年1月1日
首次发布 (实际的)
2020年1月3日
研究记录更新
最后更新发布 (实际的)
2020年1月3日
上次提交的符合 QC 标准的更新
2020年1月1日
最后验证
2020年1月1日
更多信息
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