Esketamine Combined Pulsed Radiofrequency for Acute/Subacute Zoster-associated Trigeminal Neuralgia

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

• Esketamine group (Drug), also known as Esketamine + PRF+standardized treatment: 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
• PRF group (Drug), also known as PRF + standardized group: Patients in the control group will receive PRF+standardized treatment

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 18 Years to any

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.

• Fang Luo, M.D., Principal investigator, Beijing Tiantan Hospital