Postherpetic Neuralgia
Conditions
Keywords
Postherpetic Neuralgia, esketamine
Brief summary
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).
Detailed description
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
Interventions
DRUGesketamine group
In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine.
DRUGcontrol group
receiving the combination of pregabalin and duloxetine
Sponsors
Beijing Xiaotangshan Hospital
The First Hospital of Fangshan District,Beijing
Beijing Ditan Hospital
Hengshui People's Hospital
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ages more than 18 years; 2. Pain present for more than 3 months after healing of a herpes zoster skin rash; 3. Has an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0= no pain, 10= worst possible pain)； 4. Failed to respond to or tolerate the effective dose of pregabalin monotherapy.
Exclusion criteria
1. Obstructive sleep apnoea syndrome; 2. Those who receive interventional treatments; 3. A history of systemic immune diseases, organ transplantation, or cancers; 4. A history of severe cardiopulmonary, hepatic or renal dysfunction; 5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium; 6. Currently using monoamine oxidase inhibitors (MAOIs); 7. Having untreated angle-closure glaucoma; 8. Those suffering from increased intracranial pressure； 9. Comorbid hyperthyroidism or phaeochromocytoma; 10. Suspected or confirmed history of drug abuse; 11. Having contraindications to esketamine, pregabaline or duloxetine; 12. Communication difficulties; 13. Women who are preparing for pregnancy, in the pregnancy or lactation period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the mean of daily pain scores | during 1 week | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentages of patients having >50% reductions in 24-hour average pain severity during the first week | during the first week | percentages of patients having \>50% reductions |
| the 12-item Short-Form Health Survey (SF-12) score | 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment | Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status). |
| the Pittsburgh Sleep Quality Index (PSQI) score | 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment | Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality). |
| Averaged weekly NRS score | 1 week, 2 weeks, 3 weeks, and 1 month after treatment | 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 |
| The Hospital Anxiety and Depression Scale (HADS) | 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment | 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. |
| Averaged weekly analgesic consumption | 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment | Averaged weekly consumption per analgesic of each participant |
| Safety assessments | 0 day, 1 day, 3 days, 7 days, 2 weeks,3 weeks, and 1 month after treatment | drug-related complications,such as dizziness, somnolence, gait disturbance, nausea, fatigue, diarrhea, dry mouth, mental symptom, etc |
| the Patient Global Impression of Change scale (PGIC) | 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment | The proportion of patients with a response of no change, minimally improved, much improved or very much improved on PGIC. |
Countries
China
Contacts
Primary ContactFang Luo, M.D.
Outcome results
None listed