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RecruitingNot ApplicableNCT04699734

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?

Sponsor

University of Aarhus

Enrollment

16 participants

Start Date

Sep 8, 2020

Study Type

INTERVENTIONAL

Conditions

Neuropathy;PeripheralPainful Diabetic NeuropathyNeuropathic Pain

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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.

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Interventions

DIAGNOSTIC_TESTXylocaine 1%

Nerve block

DIAGNOSTIC_TESTNaCl 9mg/ml

Nerve block

Locations(1)

Danish Pain Research Center, Aarhus University, Aarhus University Hospital

Aarhus N, Jutland, Denmark

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NCT04699734

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