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临床试验/NCT06011044
NCT06011044Unknown不适用

Intercostal Nerve Block With Local Anesthesia Administered Via Incision-specific Multi-site Injection for Thoracic Surgery

Bixin Wen0 个研究点目标入组 60 人开始时间: 2023年8月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
The Visual Analogue Scale (VAS)

研究概览

简要总结

The goal of this clinical trial is to test analgesic effect of intercostal nerve block in different range. The main question it aims to answer are:

question 1: whther incision-specific multi-site injection (ISMSI, from the 3rd to 8th intercostal nerve) can improve the analgesic benefits .

The participants will be divided into three groups to compare the analgesic effects of different intercostal nerve blocks

详细描述

Postoperative pain after thoracic surgery is usually severe, and potentially leads to worse outcomes. It is well known that the use of intercostal nerve block (ICNB) analgesia with local anesthesia is common in thoracic surgery. Compared with the traditional standard of epidural analgesia, it has the advantages of less effect on respiratory or circulation system and less postoperative complications such as hypotension and hematoma. However, the details of ICNB form different hospital are in different ways. And it is unclear how many intercostal nerves should be blocked. And it is unknown which area should be payed more attention either, like the incision area or the chest tube port. It is hypothesized that the incision-specific multi-site injection (ISMSI, from the 3rd to 8th intercostal nerve) can improve the analgesic benefits due to cover area of both incision and chest tube port. To test this hypothesis, the investigators did this study to evaluate the analgesic effect of different ICNB methods.

The participants will be divided into three groups. A(incision-specific multi-site injection, received intraoperative 3-8 intercostal nerve block ) B(single injection, received intraoperative 3-5 intercostal nerve block ) and C(received no intercostal nerve block). Then compare the analgesic effects of the three groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing surgery for small pulmonary nodules in the Department of Thoracic Surgery, China-Japan Friendship Hospital in Beijing
  • Age≥ 18 years old
  • Lung small nodules with a diameter of ≤ 2cm, pure ground-glass/mixed/solid nodules
  • Permanent residents can be followed up for a long time
  • Sign informed consent.

排除标准

  • Refusal to sign informed consent
  • Damaged heart, lung, liver and kidney function
  • Contraindications to surgery, such as inability to tolerate anesthesia, distant metastasis, bleeding tendency, etc c(4) Combined with severe emphysema, tuberculosis, pneumothorax, pleural effusion (5) Patients have other conditions that are not suitable for interventional surgery, such as pregnancy, lactation, long-term use of immunosuppressants, and serious infections

结局指标

主要结局

The Visual Analogue Scale (VAS)

时间窗: first month after surgery

We will use VAS score to assess the analgesic effects . The Visual Analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain since the 1920s. It consists of a line usually 100mm in length, with anchor descriptors such as "no pain" and "worst pain imaginable", The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm.

次要结局

  • The Visual Analogue Scale (VAS)(third month after surgery)

研究者

发起方
Bixin Wen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bixin Wen

Principal Investigator

China-Japan Friendship Hospital

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