NCT04089813

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

September 12, 2019

Last Update Submit

September 12, 2019

Conditions

Postoperative Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

Metformin

Patients use metformin to control blood sugar

Drug: Metformin

Insulin

Patients use Insulin to control blood sugar

Interventions

MetforminDRUG

Patients use metformin to control blood sugar

Metformin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

200 diabetic patients undergoing elective thoracoscopic lobectomy in the Affiliated Hospital of Xuzhou Medical University.

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Related Publications (4)

  • 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: 10.1523/JNEUROSCI.0713-18.2018. Epub 2018 Jul 20.

    PMID: 30030404RESULT

  • 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.

    PMID: 27669556RESULT

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

    PMID: 26031427RESULT

  • 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.

    PMID: 29393487RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Metformin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • JinDong Liu, M.S

    Afliated Hospital of Xuzhou Medical University

    STUDY DIRECTOR

Central Study Contacts

Jin Dong Liu, M.S

CONTACT

+86-13951355136liujindong1818@163.com

Kang Zhou

CONTACT

+86-18752117938301810612479@stu.xzhmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2019

First Posted

September 13, 2019

Study Start

September 10, 2019

Primary Completion

December 9, 2019

Study Completion

December 31, 2020

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations

CN(1)