Postamputation Pain: Peripheral Mechanisms
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|ClinicalTrials.gov Identifier: NCT03317600|
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : July 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain Amputation, Traumatic Nerve Block Phantom Limb Pain Stump Pain||Device: Lidocaine Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Postamputation Pain: Peripheral Mechanisms|
|Actual Study Start Date :||October 25, 2017|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||February 28, 2018|
|Active Comparator: Lidocaine block||
Intervention is a nerve block with Lidocaine 2% with Adrenaline.
|Placebo Comparator: Isotonic saline block||
Intervention is a "placebo" nerve block with isotonic saline
- Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain) [ Time Frame: From 0 minutes until 120 minutes after injection ]The patient will be asked about spontaneous pain, including stump and phantom pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain).
- Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain). [ Time Frame: From 0 minutes until 120 minutes after injection ]The patient will be asked about evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain). Evoked pain is triggered by a SOMEDIC brush, thermo rolls (20 degrees Celcius and 40 degrees Celcius) and pinprick with a von Frey filament (60 g).
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): NCT03317600
|Danish Pain Research Center, Aarhus University Hospital|
|Aarhus, Denmark, 8000|