Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
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|ClinicalTrials.gov Identifier: NCT04699734|
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Painful Diabetic Neuropathy Neuropathic Pain Neuropathy;Peripheral||Diagnostic Test: Xylocaine 1% Diagnostic Test: NaCl 9mg/ml||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?|
|Actual Study Start Date :||September 8, 2020|
|Estimated Primary Completion Date :||December 31, 2026|
|Estimated Study Completion Date :||December 31, 2026|
Active Comparator: Xylocaine
Diagnostic Test: Xylocaine 1%
Placebo Comparator: Isotonic saline
Diagnostic Test: NaCl 9mg/ml
- 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
- 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
- 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.
- 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)
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699734
|Contact: Ellen L Schaldemose, MD||+45 email@example.com|
|Danish Pain Research Center, Aarhus University, Aarhus University Hospital||Recruiting|
|Aarhus N, Jutland, Denmark, 8200|
|Contact: Ellen L Schaldemose, MD 93501942 firstname.lastname@example.org|
|Principal Investigator:||Ellen L Schaldemose, MD||Danish Pain Research Center, Aarhus University|