Central Post Stroke Pain
Conditions
Keywords
Central Post Stroke Pain, Nerve block
Brief summary
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.
Interventions
DRUGUltrasound-guided peripheral nerve block with 2% lidocaine
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
Sponsors
Aarhus University Hospital
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each subject must meet all of the following criteria: * Age ≥18; * CPSP affecting an upper or a lower limb, in a distribution that may be completely covered by a peripheral nerve block; * Patient fulfills all mandatory criteria for CPSP, fulfills at least one supportive criteria, and has definite CPSP by probability grading. * Pain duration at least 3 months; * Spontaneous pain intensity (average pain in past week) of ≥ 4 on 0-10 Numerical Rating Scale (NRS).
Exclusion criteria
Subjects will not be enrolled if any of the following criteria exist: * Not giving consent to participate in the study; * Significant psychiatric or cognitive impairment; * Moderate to severe renal or liver failure; * Concomitant treatment with warfarin or other anticoagulants; * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. | baseline and 30 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Intensity of Cold Sensation | baseline and 30 min | 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) |
| Change in the Intensity of Warm Sensation | baseline and 30 min | 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) |
| Change in the Intensity of Pinprick Sensation | baseline and 30 min | 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) |
| Change in the Intensity of Brush Sensation | baseline and 30 min | 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) |
| Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire | baseline and 40 min | 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): * Burning pain * Paroxysmal pain * Paresthesia/dysesthesia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| The Entire Cohort All participants received a peripheral nerve block | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | The Entire Cohort |
|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 7.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment Denmark | 1 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 4 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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
Time frame: baseline and 30 minutes
Population: ITT
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| The Entire Cohort | Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. | Baseline pain intensity | 6.5 units on a scale |
| The Entire Cohort | Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. | Pain intensity after the block | 0.0 units on a scale |
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)
Time frame: baseline and 30 min
Population: The entire cohort
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Entire Cohort | Change in the Intensity of Brush Sensation | Baseline | 4.5 units on a scale | Standard Deviation 1.9 |
| The Entire Cohort | Change in the Intensity of Brush Sensation | 30 min after block | 1.0 units on a scale | Standard Deviation 1.4 |
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)
Time frame: baseline and 30 min
Population: The entire cohort
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| The Entire Cohort | Change in the Intensity of Cold Sensation | Baseline | 7 units on a scale |
| The Entire Cohort | Change in the Intensity of Cold Sensation | 30 min after the block | 0.0 units on a scale |
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)
Time frame: baseline and 30 min
Population: The entire cohort
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Entire Cohort | Change in the Intensity of Pinprick Sensation | Baseline | 5.0 units on a scale | Standard Deviation 2.1 |
| The Entire Cohort | Change in the Intensity of Pinprick Sensation | 30 min after block | 1.1 units on a scale | Standard Deviation 2.2 |
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)
Time frame: baseline and 30 min
Population: The entire cohort
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Entire Cohort | Change in the Intensity of Warm Sensation | Baseline | 5.9 units on a scale | Standard Deviation 1.4 |
| The Entire Cohort | Change in the Intensity of Warm Sensation | 30 min after the block | 0.5 units on a scale | Standard Deviation 1.1 |
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): * Burning pain * Paroxysmal pain * Paresthesia/dysesthesia
Time frame: baseline and 40 min
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Entire Cohort | Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire | Paroxysmal pain - 40 min after block | 0.0 units on a scale | Standard Deviation 0 |
| The Entire Cohort | Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire | Burning pain- baseline | 4.1 units on a scale | Standard Deviation 3.7 |
| The Entire Cohort | Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire | burning pain - 40 min after block | 0.0 units on a scale | Standard Deviation 0 |
| The Entire Cohort | Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire | paroxysmal pain - baseline | 2.6 units on a scale | Standard Deviation 2.1 |
| The Entire Cohort | Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire | paresthesia/dysesthesia - baseline | 3.6 units on a scale | Standard Deviation 3.3 |
| The Entire Cohort | Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire | paresthesia/dysesthesia - 40 min after block | 0.9 units on a scale | Standard Deviation 1.3 |