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Recruiting Not applicable

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

NCT04699734 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2020-09-08
Last updated
2021-01-07

Condition(s) studied

Painful Diabetic NeuropathyNeuropathic PainNeuropathy;Peripheral

Investigational drug(s) / intervention(s)

Xylocaine 1%NaCl 9mg/ml

Xylocaine 1%: Nerve block

NaCl 9mg/ml: Nerve block

Study summary

The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Aged 18 years or older. * Probably diabetic neuropathy confirmed using the Toronto criteria in a "conservative manner", i.e. three out of three symptoms/signs of neuropathy must be present (sensory neuropathy symptoms, distal reduced sensibility, reduced ankle reflexes) 7. * Definite or probable neuropathic pain for minimum the last 6 months * Mean pain intensity at \> 4 NRS the last week17. Since we expect a large effect of the block it is not necessary to discontinue pain medication. Exclusion Criteria: * Other causes of pain in the same area or other pain that cannot be distinguished from the neuropathic pain. * Unable to understand and speak Danish. * Non-cooperative. * Warfarin or other medication that contraindicate regional anesthesia. * Infection in the injection area. * Allergy to lidocaine. * Pregnancy or lactating (fertile women must to show negative pregnancy test or use anticonception). * Severe psychiatric disease e.g. severe depression during the last 6 months. * Alcohol or drug abuse.

Primary outcome measure(s)

  • Indication of pain relieved extremity — 30 minutes
    Number of participants who indicated the leg with lidocaine as most pain relieved 30 minutes after block And number of participants who indicated the leg with saline as most pain relieved 30 minutes after block

Trial sites (1)

FacilityCityRegionStatus
Danish Pain Research Center, Aarhus University, Aarhus University Hospital Aarhus N Jutland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04699734 on ClinicalTrials.gov ↗ ← All trials in Denmark