Amputation, Traumatic, Nerve Block, Neuropathic Pain, Phantom Limb Pain, Stump Pain
Conditions
Brief summary
Stump and phantom pain after amputation are common, but the responsible mechanisms are still not clarified. It has been suggested that phantom limb pain can be reduced by regional anaesthesia and in several recent studies, pain was reduced following intrathecal and intraforaminal blocks. In this study, the investigators want to investigate if spontaneous and evoked pain in amputees will be relieved by regional nerve blocks involving the damaged nerves.
Interventions
DEVICELidocaine
Intervention is a nerve block with Lidocaine 2% with Adrenaline.
DRUGPlacebo
Intervention is a placebo nerve block with isotonic saline
Sponsors
Aarhus University Hospital
Danish Pain Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Amputees with chronic amputation pain (stump or phantom pain) 3 or above on NRS (numerical ratio scale).
Exclusion criteria
* Severe somatic or psychiatric diseases * Other peripheral neuropathy * Lack of ability to cooperate to the clinical examination * Allergy to Lidocaine or similar analgetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain). | 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). |
Countries
Denmark
Outcome results
None listed