Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xylocaine 1%, NaCl 9mg/ml.
- Who it may be relevant to
- Registry conditions: Painful Diabetic Neuropathy, Neuropathic Pain, Neuropathy;Peripheral. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?
Overview
The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy
Detailed 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.
Interventions
- Diagnostic test Xylocaine 1%
Nerve block - Diagnostic test NaCl 9mg/ml
Nerve block
Primary outcome measures
- Indication of pain relieved extremity [Time frame: 30 minutes]
Secondary outcome measures (5)
- Pain intensity [Time frame: 90 minutes]
- Hyperalgesia and allodynia [Time frame: 90 minutes]
- Pain relief [Time frame: 45 minutes]
- Pain symptomps [Time frame: 50 minutes]
- Distribution of evoked pain [Time frame: 60 minutes]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
Denmark · 1 center
- Danish Pain Research Center, Aarhus University, Aarhus University Hospital — Aarhus N
Publications
- Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303. PMID 20876709
Identifiers
NCT: NCT04699734 · BPN2020