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Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

Primary Purpose

Painful Diabetic Neuropathy, Neuropathic Pain, Neuropathy;Peripheral

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Xylocaine 1%

NaCl 9mg/ml

About this trial

This is an interventional diagnostic trial for Painful Diabetic Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Danish Pain Research Center, Aarhus University, Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Xylocaine

Isotonic saline

Arm Description

Nerve block

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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)

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

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.

Full Information

NCT ID

NCT04699734

First Posted

January 4, 2021

Last Updated

January 6, 2021

Sponsor

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT04699734

Brief Title

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Recruiting

Study Start Date

September 8, 2020 (Actual)

Primary Completion Date

December 31, 2026 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Painful Diabetic Neuropathy, Neuropathic Pain, Neuropathy;Peripheral

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Xylocaine

Arm Type

Active Comparator

Arm Description

Nerve block

Arm Title

Isotonic saline

Arm Type

Placebo Comparator

Arm Description

Nerve block

Intervention Type

Diagnostic Test

Intervention Name(s)

Xylocaine 1%

Intervention Description

Nerve block

Intervention Type

Diagnostic Test

Intervention Name(s)

NaCl 9mg/ml

Intervention Description

Nerve block

Primary Outcome Measure Information:

Title

Indication of pain relieved extremity

Description

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Pain intensity

Description

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

Title

Hyperalgesia and allodynia

Description

Time Frame

90 minutes

Title

Pain relief

Description

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

Title

Pain symptomps

Description

Time Frame

50 minutes

Title

Distribution of evoked pain

Description

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.

Time Frame

60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ellen L Schaldemose, MD

Phone

+45 93501942

ells@clin.au.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ellen L Schaldemose, MD

Organizational Affiliation

Danish Pain Research Center, Aarhus University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Danish Pain Research Center, Aarhus University, Aarhus University Hospital

City

Aarhus N

State/Province

Jutland

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ellen L Schaldemose, MD

Phone

93501942

ells@clin.au.dk

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20876709

Citation

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.

Results Reference

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Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

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