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临床试验/NCT04089813
NCT04089813Unknown不适用

Effect of Metformin on Chronic Pain After Thoracic Surgery in Diabetic Patients

Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Incidence of chronic pain after operation

研究概览

简要总结

Metformin has been found to have more and more functions as a commonly used hypoglycemic drug in clinic. It has been found that metformin has anti-inflammatory, anti-tumor and lipid metabolism regulating effects. Basic studies have shown that metformin as an adjuvant drug combined with gabapentin and tramadol is safe and effective in patients with neuropathic pain. Postoperative chronic pain as a common complication has seriously affected the quality of life and mood of patients after surgery.Some studies have shown that chronic pain after partial operation manifests as neuropathic pain. The effect of metformin on chronic pain after thoracic surgery in patients with diabetes mellitus was observed in this experiment, which was compared with patients taking insulin to control blood sugar.

详细描述

The analgesic mechanism of metformin may include the following aspects:(1)Metformin relieves neuropathic pain mainly because it can activate adenosine monophosphate-activated protein kinase (AMPK), which plays a crucial role in pain regulation as an important endogenous kinase controlling energy metabolism.(2)In addition, metformin can also inhibit ERK signaling pathway, further inhibit sodium channel, prevent the development of peripheral sensitization and achieve the effect of relieving neuropathic pain. (3)Metformin has been shown to alleviate bone cancer pain in rats by reducing STAT3 phosphorylation.Clinical research in this field is limited to basic research and ethical requirements are rarely reported at home and abroad. Li Chunye et al. of Jiangsu University designed a clinical trial to compare the efficacy of metformin and gabapentin combined with tramadol on neuropathic pain. The results showed that metformin had a better effect.

The incidence of chronic pain after thoracic surgery is higher. Postoperative chronic pain is a complex pain. The nature and mechanism of chronic pain after thoracic surgery are still controversial. Some studies have shown that some chronic pain after thoracic surgery manifests neuropathic pain, the mechanism may be related to surgical incision, nerve injury caused by trauma and increased pain sensitization. Can metformin alleviate chronic pain after surgery? The research on this aspect is still blank at present.This study was designed as a prospective cohort study to observe whether there was a difference in the incidence of chronic pain after thoracoscopic lobectomy between patients taking metformin and patients injecting insulin to control blood sugar.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 70
  • Diabetes history. Use metformin or insulin to control blood sugar
  • The type of operation is selective thoracoscopic lobectomy.

排除标准

  • Newly diagnosed diabetic patients at admission
  • Complication of severe cardiopulmonary diseases
  • Refuse to participate in this experiment
  • Participate in other trials
  • Patients with diabetic complications (including diabetic nephropathy, peripheral neuropathy, etc.)

研究组 & 干预措施

Metformin

Patients use metformin to control blood sugar

干预措施: Metformin (Drug)

结局指标

主要结局

Incidence of chronic pain after operation

时间窗: 3 months after operation

A VAS score greater than or equal to 3 is defined as the presence of chronic pain after surgery.

次要结局

  • VAS score at extubation time, 12 hours and 24 hours after operation(extubation time, 12 hours and 24 hours after operation)
  • Neuropathic pain score and incidence at 3 months after operation(3 months after operation)
  • Anxiety and Depression Score(3 months after operation)
  • Length of ICU stay(an average of 2 days)
  • Length of hospital stay(an average of 10 days)

研究者

发起方
Xuzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin Dong Liu

Principal Investigator

Xuzhou Medical University

研究点 (1)

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