Esketamine Combined Pulsed Radiofrequency for Acute/Subacute Zoster-associated Trigeminal Neuralgia
NCT ID: NCT06890897
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
174 participants
INTERVENTIONAL
2025-04-01
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Esketamine group
Besides PRF plus standardized treatment, patients will also receive intravenous infusion of Esketamine ;
Esketamine 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
control group
Patients will only receive PRF plus standardized treatment
PRF group
Patients in the control group will receive PRF+standardized treatment
Interventions
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Esketamine 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
PRF group
Patients in the control group will receive PRF+standardized treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Beijing Xiaotangshan Hospital
OTHER
The First Hospital of Fangshan District,Beijing
OTHER
Beijing Ditan Hospital
OTHER
Hengshui People's Hospital
OTHER
Beijing Tiantan Hospital
OTHER
Responsible Party
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Fang Luo
Director of Department of Day surgery and Pain Management Affiliation
Principal Investigators
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Fang Luo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY-2024-332-02-01
Identifier Type: -
Identifier Source: org_study_id
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