Zoster; Herpes, Trigeminal Neuralgia (Etiology)
Conditions
Keywords
acute/subacute zoster-associated trigeminal neuralgia, esketamine, pulsed radiofrequency
Brief summary
To assess the 1-month effects and safety of esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute zoster-related trigeminal neuralgia(ZRTN).
Detailed description
The investigators aim to investigate whether or not esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute ZRTN , and seek a safe, and effective treatment for refractory patients with ZRTN
Interventions
DRUGEsketamine group
Patients in the esketamine group will receive intravenous infusion of esketamine besides PRF+standardized treatment.The formula will be intravenous infusion of 0.5mg/kg of esketamine diluted in 50 mL normal saline, starting with intravenous injection of 10 mg of esketamine for 1 minute, and maintaining a dose 8 mg/h.The infusion rate will be adjusted the parameter according to the tolerance of the patients
DRUGPRF group
Patients in the control group will receive PRF+standardized treatment
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. Age \>18 years; 2. History of HZ within the last three months; 3. Lesions located in the trigeminal nerve or its branches innervated regions； 4. Numeric Rating Scale (NRS) pain score≥4 (NRS, 0 = no pain, 10= worst possible pain) with pharmacotherapy; 5. Planned to perform CT-guided PRF treatment of the Gasserian ganglion .
Exclusion criteria
1. Obstructive sleep apnoea syndrome; 2. Those who receive other invasive treatments, such as spinal cord stimulation; 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. Comorbid hyperthyroidism or phaeochromocytoma; 7. Recent history of drug abuse; 8. Having contraindications to esketamine; 9. Communication difficulties. Withdrawal criteria 1. Lost to follow-up during the study; 2. Not perform the planned operation; 3. Receiving other treatment regimes during the study period; 4. Not suitable for continuing the study for emerging severe comorbidities or special physiological changes during the study; 5. Voluntary withdrawal from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the NRS score at 1 month after treatment. | 1-month period | The Numeric Rating Scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the 12-item Short-Form Health Survey (SF-12) score | at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months 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 | at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment | Sleep quality measured by PSQI score（range 0-21, with higher scores indicating poorer sleep quality） |
| the Patient Global Impression of Change scale (PGIC) | at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment | The proportion of patients with a response of no change, minimally improved, much improved or very much improved on PGIC |
| Analgesics consumption | at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment | the type of analgesics and analgesics consumption |
| Safety assessments | at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months | intraoperative complications, PRF-related complications, Eskatamine-related complications |
Countries
China
Contacts
Primary ContactFang Luo, M.D.
Outcome results
None listed