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NCT Number: NCT04699734

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Pain Research Center, Aarhus University, Aarhus University Hospital

Aarhus N, Jutland, 8200, Denmark

Location status: Recruiting

Location contact

Ellen L Schaldemose, MD

CONTACT

[email protected]

93501942

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xylocaine 1%

Diagnostic Test

Nerve block

NaCl 9mg/ml

Diagnostic Test

Nerve block

Primary outcomes

  1. Indication of pain relieved extremity

    Time frame: 30 minutes

    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

Secondary outcomes

  1. Pain intensity

    Time frame: 90 minutes

    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

  2. Hyperalgesia and allodynia

    Time frame: 90 minutes

    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.

  3. Pain relief

    Time frame: 45 minutes

    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)

  4. Pain symptomps

    Time frame: 50 minutes

    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

  5. Distribution of evoked pain

    Time frame: 60 minutes

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ellen L Schaldemose, MD

CONTACT

[email protected]

+45 93501942

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2021
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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