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The overarching aim of this study is to investigate the contribution of peripheral afferent input to spontaneous and evoked central neuropathic pain after a spinal cord lesion or disease.
A key question that has been subject to longstanding debates in the field relates to the sites and mechanisms within the peripheral or central nervous system that potentially perpetuate chronic spontaneous and evoked central neuropathic pain. The investigators hypothesize that spontaneous central neuropathic pain depends on continuous, "physiological" somatosensory input from the painful body region in the periphery. Thus, spontaneous central neuropathic pain results from pathological gain control in central somatosensory networks with decreased activation thresholds for thermo- and mechanosensitive peripheral afferents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | Nerve block |
|
| Isotonic saline | Placebo Comparator | Nerve block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine (10 mg/ml) | Diagnostic Test | Lidocaine (10 mg/ml) will be injected according to established protocols using ultrasound guidance and an aseptic technique by an experienced anesthesiologist. |
| Measure | Description | Time Frame |
|---|---|---|
| Indication of most pain relief | Limb with most pain relief on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] 40 minutes after nerve block | 40 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] of spontaneous pain | Intensity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] of spontaneous pain in the pre-specified region covered by the block 40, 60 and 90 min after the nerve block compared to baseline | 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma lidocaine concentrations | Plasma lidocaine concentrations approx. 40 min after the block. | 40 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nanna B. Finnerup, Professor | Contact | 0045 784 63380 | finnerup@clin.au.dk | |
| Jan Rosner, MD | Contact | 0041 79 952 4551 | jan.rosner@balgrist.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jan Rosner, MD | Danish Pain Research Center, Department of Clinical Medicine, Aarhus University | Principal Investigator |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| D013595 | Syringomyelia |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| Isotonic saline | Diagnostic Test | Isotonic saline will be injected according to established protocols using ultrasound guidance and an aseptic technique by an experienced anesthesiologist. |
|
| Pain relief 45 min after the nerve block |
Pain relief 45 min after the nerve block using a 6-point verbal scale ranging from worse pain to no, little, moderate, good and complete pain relief (-1 to 4) |
| 45 minutes |
| Pain extent [% of body surface on standardized pain drawings] 50 minutes after the nerve block | Pain extent will be mapped on standardized pain drawings 50 minutes after the nerve block compared to baseline | 50 minutes |
| Pain descriptors 50 minutes after the nerve block | Pain descriptors (burning, squeezing, pins and needles, tingling, stabbing, electrical shocks) are captured 50 minutes after the nerve block compared to baseline | 50 minutes |
| Area [% of pain extent] of hypersensitivity to thermal and nociceptive stimuli | Area of hypersensitivity [% of pain extent] to warm (40°C) and cold (20°C) thermo rollers (Somedic AB, Hörby, Sweden), pinprick (Semmes-Weinstein monofilament no 5.88 (bending force 75.9 g/745 mN)), and brush (SENSELab Brush-05; Somedic AB, Hörby, Sweden), if any, 55 and 95 min after nerve block compared to baseline | 95 minutes |
| Intensity of hypersensitivity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] to thermal and nociceptive stimuli | Intensity of hypersensitivity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] to warm (40°C) and cold (20°C) thermo rollers (Somedic AB, Hörby, Sweden), pinprick (Semmes-Weinstein monofilament no 5.88 (bending force 75.9 g/745 mN)), and brush (SENSELab Brush-05; Somedic AB, Hörby, Sweden), if any, 55 and 95 min after nerve block compared to baseline | 95 minutes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |