Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

University of Aarhus16 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Painful Diabetic Neuropathy Neuropathic Pain Neuropathy;Peripheral

Interventions

Xylocaine 1%DIAGNOSTIC_TEST

Nerve block

NaCl 9mg/mlDIAGNOSTIC_TEST

Nerve block

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Danish Pain Research Center, Aarhus University, Aarhus University Hospital

Aarhus N, Jutland, Denmark

RECRUITING

Outcomes

Primary Outcomes

Indication of pain relieved extremity

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

Time frame: 30 minutes

Secondary Outcomes

Pain intensity

Intensity of spontaneous pain (Numeric Rating Scale (NRS) 0-10, 0=no pain 10=worst pain imaginable) 30, 45, 60 and 90 minutes after block

Time frame: 90 minutes

Hyperalgesia and allodynia

Intensity of hyperalgesia and allodynia from -5 to 5 (-5 = no sensation, 0=normal sensation, 5=extremely intense sensation) to brush, pinprick, cold and warm at baseline and if there is registered any signs of hyperexcitability at baseline then 35, 60 and 90 minutes after nerve block.

Time frame: 90 minutes

Pain relief

Pain relief at 45 minutes after block assessed using a 6-point scale compared to pain intensity at baseline. (-1 = worse pain 0=no relief 1= little 2= moderate 3=good 4=complete)

Time frame: 45 minutes

Pain symptomps

Intensity of neuropathic pain symptoms 50 minutes after nerve block Burning: NRS (0-10), 0=no burning 10=worst burning imaginable Squeezing: NRS (0-10), 0=no squeezing 10=worst squeezing imaginable Pressure: NRS (0-10), 0=no pressure 10=worst pressure imaginable Tingling: NRS (0-10), 0=no tingling 10=worst tingling imaginable

Time frame: 50 minutes

Distribution of evoked pain

The distribution of any evoked pain to brush, pinprick, cold and warm before and 60 minutes after nerve block will be mapped using a filt pen and afterwards photographed.

Central Contacts

Ellen L Schaldemose, MD

CONTACT

+45 93501942 ells@clin.au.dk

Data from ClinicalTrials.gov

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