RecruitingNot ApplicableNCT06890897

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

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


Sponsor

Beijing Tiantan Hospital

Enrollment

174 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria15

  • 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.

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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


Locations(1)

Beijing Tiantan Hospital

Beijing, China

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NCT06890897