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

Postoperative Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04089813
• Other study ID #: XYFY2019-0003
• Status: Not yet recruiting
• Start date: September 10, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: Xuzhou Medical University
• Contact: Jin Dong Liu, M.S
• Phone: +86-13951355136
• Email: liujindong1818[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Aged between 18 and 70

2. Diabetes history. Use metformin or insulin to control blood sugar

3. The type of operation is selective thoracoscopic lobectomy.

Exclusion Criteria:

1. Newly diagnosed diabetic patients at admission

2. Complication of severe cardiopulmonary diseases

3. Refuse to participate in this experiment

4. Participate in other trials

5. Patients with diabetic complications (including diabetic nephropathy, peripheral neuropathy, etc.)

Related Conditions & MeSH terms

• Chronic Pain
• Postoperative Chronic Pain

Intervention

Drug:
• Metformin
Patients use metformin to control blood sugar

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Ge A, Wang S, Miao B, Yan M. Effects of metformin on the expression of AMPK and STAT3 in the spinal dorsal horn of rats with neuropathic pain. Mol Med Rep. 2018 Apr;17(4):5229-5237. doi: 10.3892/mmr.2018.8541. Epub 2018 Feb 1. — View Citation

Pecikoza UB, Tomic MA, Micov AM, Stepanovic-Petrovic RM. Metformin Synergizes With Conventional and Adjuvant Analgesic Drugs to Reduce Inflammatory Hyperalgesia in Rats. Anesth Analg. 2017 Apr;124(4):1317-1329. doi: 10.1213/ANE.0000000000001561. — View Citation

Shiers S, Pradhan G, Mwirigi J, Mejia G, Ahmad A, Kroener S, Price T. Neuropathic Pain Creates an Enduring Prefrontal Cortex Dysfunction Corrected by the Type II Diabetic Drug Metformin But Not by Gabapentin. J Neurosci. 2018 Aug 15;38(33):7337-7350. doi: — View Citation

Smith B, Ang D. Metformin: Potential analgesic? Pain Med. 2015 Dec;16(12):2256-60. doi: 10.1111/pme.12816. Epub 2015 May 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chronic pain after operation	A VAS score greater than or equal to 3 is defined as the presence of chronic pain after surgery.	3 months after operation
Secondary	VAS score at extubation time, 12 hours and 24 hours after operation	A VAS score greater than or equal to 3 is defined as the presence of pain after surgery.	extubation time, 12 hours and 24 hours after operation
Secondary	Neuropathic pain score and incidence at 3 months after operation	Assessment of the presence of neuropathic pain by using self-rating scale	3 months after operation
Secondary	Anxiety and Depression Score	Assessment of Anxiety and Depression in Patients by HAMD Depression Scale	3 months after operation
Secondary	Length of ICU stay	Some patients may need to be transferred to ICU.	an average of 2 days
Secondary	Length of hospital stay	Total length of hospitalization	an average of 10 days