Clinical trial NCT06890897: Esketamine Combined Pulsed Radiofrequency for Acute/Subacute Zoster-associated Trigeminal Neuralgia
Official title: Effect of Intravenous Infusion of Esketamine Combined Pulsed Radiofrequency on Acute/Subacute Zoster-associated Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Zoster; Herpes, Trigeminal Neuralgia (Etiology)
Keywords: acute/subacute zoster-associated trigeminal neuralgia
esketamine
pulsed radiofrequency
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Xiaotangshan Hospital
name: The First Hospital of Fangshan District,Beijing
name: Beijing Ditan Hospital
name: Hengshui People's Hospital
First posted: 2025-03-24
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: the NRS score at 1 month after treatment.
timeFrame: 1-month period
Secondary outcomes:
measure: the 12-item Short-Form Health Survey (SF-12) score
timeFrame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
measure: the Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
measure: the Patient Global Impression of Change scale (PGIC)
timeFrame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
measure: Analgesics consumption
timeFrame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
measure: Safety assessments
timeFrame: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: