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Recruiting NCT06890897

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

No phase Interventional Zoster; Herpes, Trigeminal Neuralgia (Etiology)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esketamine group, PRF group.
Who it may be relevant to
Registry conditions: Zoster; Herpes, Trigeminal Neuralgia (Etiology). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Intravenous Infusion of Esketamine Combined Pulsed Radiofrequency on Acute/Subacute Zoster-associated Trigeminal Neuralgia

Overview

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

  • Drug 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
  • Drug PRF group
    Patients in the control group will receive PRF+standardized treatment

Primary outcome measures

  • the NRS score at 1 month after treatment. [Time frame: 1-month period]
Secondary outcome measures (5)
  • the 12-item Short-Form Health Survey (SF-12) score [Time frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment]
  • the Pittsburgh Sleep Quality Index (PSQI) score [Time frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment]
  • the Patient Global Impression of Change scale (PGIC) [Time frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment]
  • Analgesics consumption [Time frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment]
  • Safety assessments [Time frame: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months]

Eligibility criteria

Inclusion criteria

  • Age >18 years;
  • History of HZ within the last three months;
  • Lesions located in the trigeminal nerve or its branches innervated regions；
  • Numeric Rating Scale (NRS) pain score≥4 (NRS, 0 = no pain, 10= worst possible pain) with pharmacotherapy;
  • Planned to perform CT-guided PRF treatment of the Gasserian ganglion .

Exclusion criteria

  • Obstructive sleep apnoea syndrome;
  • Those who receive other invasive treatments, such as spinal cord stimulation;
  • A history of systemic immune diseases, organ transplantation, or cancers;
  • A history of severe cardiopulmonary, hepatic or renal dysfunction;
  • A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
  • Comorbid hyperthyroidism or phaeochromocytoma;
  • Recent history of drug abuse;
  • Having contraindications to esketamine;
  • Communication difficulties.

Withdrawal criteria

  • Lost to follow-up during the study;
  • Not perform the planned operation;
  • Receiving other treatment regimes during the study period;
  • Not suitable for continuing the study for emerging severe comorbidities or special physiological changes during the study;
  • Voluntary withdrawal from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT06890897 · KY-2024-332-02-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗