Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699734
• Other study ID #: BPN2020
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2020
• Source: University of Aarhus
• Contact: Ellen L Schaldemose, MD
• Phone: +45 93501942
• Email: ells[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia
• Neuropathic Pain
• Neuropathy;Peripheral
• Pain
• Painful Diabetic Neuropathy
• Peripheral Nervous System Diseases
• Polyneuropathies

Intervention

Diagnostic Test:
• Xylocaine 1%
Nerve block
• NaCl 9mg/ml
Nerve block

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University, Aarhus University Hospital	Aarhus N	Jutland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. Review. Erratum in: Diabetes Care. 2010 Dec;33(12):2725. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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