Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

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

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

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain; Painful Diabetic Neuropathy; Neuropathy;Peripheral
• Intervention / Treatment: Diagnostic test: Xylocaine 1%; Diagnostic test: NaCl 9mg/ml

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen L Schaldemose, MD; Phone Number: +45 93501942; Email: ells@clin.au.dk

Study Locations

• Denmark
  • Jutland
    • Aarhus N, Jutland, Denmark, 8200
      • Recruiting
      • Danish Pain Research Center, Aarhus University, Aarhus University Hospital
      • Contact: Ellen L Schaldemose, MD; Phone Number: 93501942; Email: ells@clin.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Isotonic saline; Nerve block	Diagnostic test: NaCl 9mg/ml; Nerve block
Active Comparator: Xylocaine; Nerve block	Diagnostic test: Xylocaine 1%; Nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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)	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	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.	60 minutes

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Ellen L Schaldemose, MD, Danish Pain Research Center, Aarhus University

Publications and helpful links

General 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. Erratum In: Diabetes Care. 2010 Dec;33(12):2725.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases; Pain; Polyneuropathies; Diabetic Neuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: BPN2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No