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NCT Number: NCT06890897

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

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).

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esketamine group

Drug

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

Other names: Esketamine + PRF+standardized treatment

PRF group

Drug

Patients in the control group will receive PRF+standardized treatment

Other names: PRF + standardized group

Primary outcomes

  1. the NRS score at 1 month after treatment.

    Time frame: 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

  1. 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

    Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status)

  2. the Pittsburgh Sleep Quality Index (PSQI) score

    Time frame: 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)

  3. 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

    The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC

  4. Analgesics consumption

    Time frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment

    the type of analgesics and analgesics consumption

  5. Safety assessments

    Time frame: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months

    intraoperative complications, PRF-related complications, Eskatamine-related complications

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo, M.D.

CONTACT

[email protected]

+86 13611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Ditan Hospital
  • Beijing Xiaotangshan Hospital
  • Hengshui People's Hospital
  • The First Hospital of Fangshan District,Beijing

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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