Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Xylocaine 1%
Diagnostic testNerve block
NaCl 9mg/ml
Diagnostic testNerve block
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: XylocaineActive comparator 1 intervention
Group B: Isotonic salinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
30 minutesSecondary outcomes
1
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
Time frame
90 minutes2
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.
Time frame
90 minutes3
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)
Time frame
45 minutes4
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
Time frame
50 minutesSponsors and contacts
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Source ClinicalTrials.gov