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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked thermal and mechanical responses in CPSP, and assesses the associated local anesthetic pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain testing | Experimental | Completion of NPSI questionnaire Sensory mapping of the affected limb Quantitative Sensory Testing Patients will have a peripheral nerve blockade |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided peripheral nerve block with 2% lidocaine | Drug | Patients will have a peripheral nerve blockade with a local anesthetic (lidocaine) Assessment of spontaneous and evoked pain responses Completion of NPSI questionnaire Mapping of the affected limb |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. | Reduction in spontaneous pain intensity in the painful extremity from baseline to 30 minutes after a peripheral nerve block.Spontaneous pain intensity was measured on 0-10 numerical rating scale (NRS), where 0 represents "no pain", and 10 represents "worst pain imaginable" | baseline and 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Intensity of Cold Sensation | The intensity of cold sensation (application of roller cooled down to 20 degrees Celsius) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful cold); lower scores represent reduced sensitivity (0=no cold sensation) | baseline and 30 min |
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Each subject must meet all of the following criteria:
Exclusion Criteria
Subjects will not be enrolled if any of the following criteria exist:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Haroutounian, PHD | Washington Univesity School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | The Entire Cohort | All participants received a peripheral nerve block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | The Entire Cohort | All participants received a peripheral nerve block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. | Reduction in spontaneous pain intensity in the painful extremity from baseline to 30 minutes after a peripheral nerve block.Spontaneous pain intensity was measured on 0-10 numerical rating scale (NRS), where 0 represents "no pain", and 10 represents "worst pain imaginable" | ITT | Posted | Median | Inter-Quartile Range | units on a scale | baseline and 30 minutes |
|
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Entire Cohort | All participants received a peripheral nerve block | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perioral numbness | Nervous system disorders | Systematic Assessment | Two patients reported perioral numbness for 14 and 10 minutes, respectively. Resolved spontaneously |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simon Haroutounian | Washington University School of Medicine | 3142861715 | 314 | simon.haroutounian@wustl.edu |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Change in the Intensity of Warm Sensation | The intensity of warm sensation (application of roller heated up to 40 degrees Celsius) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful hot); lower scores represent reduced sensitivity (0=no warmth sensation) | baseline and 30 min |
| Change in the Intensity of Pinprick Sensation | The intensity of pinprick sensation (application of Semmes-Weinstein monofilament #6.1, ~100g target force) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful sharp); lower scores represent reduced sensitivity (0=no pricking sensation) | baseline and 30 min |
| Change in the Intensity of Brush Sensation | The intensity of brush sensation (application of SENSELab Brush-05) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful brushing sensation); lower scores represent reduced sensitivity (0=no brushing sensation) | baseline and 30 min |
| Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire | Composite scores on NPSI (Neuropathic Pain Symptom Inventory) questionnaire before and 40 minutes after the peripheral nerve block. The NPSI assesses participant ranking of specific neuropathic pain descriptors, each ranked on a 0-10 scale, where 0 represents no burning/squeezing/electric shocks (etc), and 10 represents worst burning/squeezing/electric shocks (etc). The scores on individual questions are grouped (averaged) into the three following subscales (each subscale scores ranging from 0 to 10):
| baseline and 40 min |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Change in the Intensity of Cold Sensation | The intensity of cold sensation (application of roller cooled down to 20 degrees Celsius) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful cold); lower scores represent reduced sensitivity (0=no cold sensation) | The entire cohort | Posted | Median | Inter-Quartile Range | units on a scale | baseline and 30 min |
|
|
|
| Secondary | Change in the Intensity of Warm Sensation | The intensity of warm sensation (application of roller heated up to 40 degrees Celsius) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful hot); lower scores represent reduced sensitivity (0=no warmth sensation) | The entire cohort | Posted | Mean | Standard Deviation | units on a scale | baseline and 30 min |
|
|
|
| Secondary | Change in the Intensity of Pinprick Sensation | The intensity of pinprick sensation (application of Semmes-Weinstein monofilament #6.1, ~100g target force) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful sharp); lower scores represent reduced sensitivity (0=no pricking sensation) | The entire cohort | Posted | Mean | Standard Deviation | units on a scale | baseline and 30 min |
|
|
|
| Secondary | Change in the Intensity of Brush Sensation | The intensity of brush sensation (application of SENSELab Brush-05) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful brushing sensation); lower scores represent reduced sensitivity (0=no brushing sensation) | The entire cohort | Posted | Mean | Standard Deviation | units on a scale | baseline and 30 min |
|
|
|
| Secondary | Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire | Composite scores on NPSI (Neuropathic Pain Symptom Inventory) questionnaire before and 40 minutes after the peripheral nerve block. The NPSI assesses participant ranking of specific neuropathic pain descriptors, each ranked on a 0-10 scale, where 0 represents no burning/squeezing/electric shocks (etc), and 10 represents worst burning/squeezing/electric shocks (etc). The scores on individual questions are grouped (averaged) into the three following subscales (each subscale scores ranging from 0 to 10):
| Posted | Mean | Standard Deviation | units on a scale | baseline and 40 min |
|
|
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| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
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| Dizziness | Nervous system disorders | Systematic Assessment | One subject reported dizziness (for 10 minutes), resolved spontaneously |
|
| Vasovagal response | Nervous system disorders | Non-systematic Assessment | One patient experienced a vasovagal response during needle placement, but recovered uneventfully, and the study team proceeded with the block 5 minutes thereafter |
|
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| Aniline Compounds |
| D000588 | Amines |
| Title | Measurements |
|---|---|
|
| Paroxysmal pain - 40 min after block |
|
| paresthesia/dysesthesia - baseline |
|
| paresthesia/dysesthesia - 40 min after block |
|