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| Name | Class |
|---|---|
| Beijing Xiaotangshan Hospital | OTHER |
| The First Hospital of Fangshan District,Beijing | OTHER |
| Beijing Ditan Hospital | OTHER |
| Hengshui People's Hospital |
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To assess the 1-week effects and safety of esketamine in combination with pregabalin and duloxetine to relieve pain in patients with postherpetic Neuralgia(PHN).
The investigators aim to investigate whether or not esketamine combined with pregabalin and duloxetine to relieve pain in patients with PHN, and seek a rapid, effective and safe treatment for refractory patients with PHN
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the esketamine group | Experimental | In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine. A total of 0.5 mg/kg of esketamine will be diluted in 50 mL of normal saline. The infusion will commence with an intravenous injection of 10 mg of esketamine over 1 minute, followed by a maintenance dose of 8 mg/h. The infusion rate will be adjusted based on the patients' tolerance levels. |
|
| the control group | Placebo Comparator | In the control group, patients will receive pregabaline combined with duloxetine. Pregabaline will be administered at a dose of 50-75 mg, twice daily during the first 3 days of treatment, and increase to 300mg daily after 3-7days, then by an additional 150mg daily every 3-7 days as tolerated, up to a maximum daily dose of 600mg. Meanwhile, duloxetine will be prescribed at an initial daily dose of 30mg, and then gradually increased to 60 mg daily after one week if patients tolerate it well. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esketamine group | Drug | In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine. |
| Measure | Description | Time Frame |
|---|---|---|
| the mean of daily pain scores | the mean of daily pain scores collected during week 1 of treatment measured using the Numerical Pain Rating Scale (NRS,, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain). | during 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Averaged weekly NRS score | Averaged weekly NRS score of each participant.Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain | 1 week, 2 weeks, 3 weeks, and 1 month after treatment |
| percentages of patients having >50% reductions in 24-hour average pain severity during the first week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo, M.D. | Contact | +86 13611326978 | 13611326978@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Luo, M.D. | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| OTHER |
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| control group | Drug | receiving the combination of pregabalin and duloxetine |
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percentages of patients having >50% reductions |
| during the first week |
| the 12-item Short-Form Health Survey (SF-12) score | Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status). | 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment |
| the Pittsburgh Sleep Quality Index (PSQI) score | Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality). | 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment |
| the Patient Global Impression of Change scale (PGIC) | The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC. | 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment |
| The Hospital Anxiety and Depression Scale (HADS) | It consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression. | 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment |
| Averaged weekly analgesic consumption | Averaged weekly consumption per analgesic of each participant | 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment |
| Safety assessments | drug-related complications,such as dizziness, somnolence, gait disturbance, nausea, fatigue, diarrhea, dry mouth, mental symptom, etc | 0 day, 1 day, 3 days, 7 days, 2 weeks,3 weeks, and 1 month after treatment |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |