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Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Description

Both peripheral and central changes in the nervous system contribute to the development of painful diabetic neuropathy, but how these changes contribute to the pain generation remains yet to be fully understood.

The purpose of this study is to evaluate if a peripheral regional nerve block relieves spontaneous pain in painful diabetic polyneuropathy.

Eligibility

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.

Study details
    Painful Diabetic Neuropathy
    Neuropathic Pain
    Neuropathy;Peripheral

NCT04699734

University of Aarhus

27 January 2024

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