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Background Subanesthetics concentrations of lidocaine are able to produce a differential block of the ectopic discharges, but not propagation of impulses, suppressing differentially the associated neuropathic pain symptoms. The aim of this study was to investigate the differences between the analgesic effects of lidocaine 0.5% and a control group of lidocaine 0.1% on several neuroma related pain modalities.
Methods Sixteen patients with neuropathic pain due to painful neuromas caused by nerve injury participated in this randomized, double-blind experiment. The patterns of sensory changes were compared before and after injection of 1 ml lidocaine 0.5% and 0.1% close to the neuroma, the sessions being 1-2 weeks apart. Spontaneous and evoked pains were assessed using a visual analogue scale (VAS), quantitative and qualitative sensory testing.
Patients were recruited by using a postal follow up questionnaire . The number of enrolled subjects in this study- 16 patients, Study design
Administration of study drug The patients were randomized by a computer generated random list to receive either 1ml lidocaine 0.5% (A) or 1 ml 0.1% (B-control) injected perineuromally.
Pain assessments Duration of the present pain condition was recorded. The patients were asked to rate the mean, maximum, minimum pain intensity of their spontaneous and evoked pain in the week prior to both visits. The pain score was measured from baseline until 60 min after injection. Assessments of pain were done post injection at 15 s, 30 s, 1 min, and at 5-min intervals for the first 30-min post injection and then every 10-min to 1 hr post injection. The assessments of pain were performed between the limbs in the following order: spontaneous pain, then assessment of dynamic mechanical allodynia and then pinprick hyperalgesia.
Spontaneous pain Evaluation of sensory function was performed in the affected limb using bedside examination according to EFNS (European Federation of Neurological Societies)guidelines: light touch, pinprick sense, warmth (40°) and cold (25°) temperature stimuli were tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine (Xylocaine) 0.5% | Active Comparator | Injection of 1ml after mixing Lidocaine 10 mg/ml 1 ml +1 ml NaCl was administrated perineuromally |
|
| Lidocaine (Xylocaine) 10 mg/ml 0.01% | Placebo Comparator | Injection of 1 ml from 10 mg/ml 1 ml lidocaine Xylocaine +10 ml Nacl was adminsitrated perineuromally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine (Xylocaine) | Drug | perineuromally administration of 1 ml lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary end-point measure was defined as the change in pain score measured from baseline until 60 min after injection | 60 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 24, 2014 | |
| Reset | Dec 1, 2014 | |
| Release | Mar 27, 2015 | |
| Reset | Apr 13, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 24, 2014 | Dec 1, 2014 | |||
| Mar 27, 2015 |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| D012492 | Salts |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| NaCl | Dietary Supplement | perineuromally administration of NaCL |
|
|
| Apr 13, 2015 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |