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NCT Number: NCT06914180

Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia

This trial's primary objective is to compare the analgesic efficacy of esketamine in combination with pulsed radiofrequency (PRF) against that of PRF monotherapy in patients with trigeminal postherpetic neuralgia (TPHN).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

About this study

This study aims to determine whether the addition of esketamine to the PRF regimen can relieve pain in TPHN patients. By doing so, the research endeavors to identify a rapid, effective, and safe treatment approach for refractory TPHN patients

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages more than 18 years;
  • Pain persisting for over three months following the onset of the herpes zoster skin rash;
  • Lesions located in the trigeminal nerve or its branches innervated regions;
  • Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain);
  • Planned to perform CT-guided PRF treatment of the gasserian ganglion(GG).

Exclusion criteria

  • Obstructive sleep apnoea syndrome;
  • Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of GG.
  • A history of systemic immune diseases, organ transplantation, or cancers;
  • A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;
  • A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
  • Comorbid hyperthyroidism or phaeochromocytoma;
  • Recent history of drug abuse;
  • Having contraindications to esketamine;
  • Communication difficulties.
  • Women who are preparing for pregnancy, in the pregnancy or lactation period.

Treatment and study plan

Esketamine group

Drug

In the esketamine group, in addition to receiving PRF treatment+pregabalin for rescue analgesia, patients will also undergo a single intravenous infusion of esketamine. A total of 0.5 mg/kg of esketamine will be diluted in 50 mL of normal saline. The infusion will commence with an intravenous injection of 10 mg of esketamine over 1 minute, followed by a maintenance dose of 8 mg/h. The infusion rate will be adjusted based on the patients' tolerance levels.

Other names: esketamine+PRF

Control group

Drug

In the control group, patients will receive PRF+pregabaline treatment. Pulsed radiofrequency (PRF) will be performed on GG by a designated physician in each participating center. PRF treatment (PMG-230, Baylis Medical Inc.) targeting to GG will be applied for 900 seconds. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. Regarding pregabalin, the dosage is titrated based on patients'pain intensity and tolerance. This process fully accounts for individual patient differences to optimize treatment outcomes.

Other names: PRF

Primary outcomes

  1. 1.the difference between the means of the daily mean pain scores over the first 7 days, measured on an 11-point Numeric Rating Scale(NRS)

    Time frame: 7-day period

    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. average weekly NRS score

    Time frame: up to 12 weeks

    average weekly NRS score of each participants for rescue analgesia.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

  2. averaged weekly analgesic consumption

    Time frame: up to 12 weeks

    averaged weekly consumption per analgesic of each participant

  3. the 12-item Short-Form Health Survey (SF-12) score

    Time frame: At the end of weeks 1, 2, 4, 8, and 12 after treatment

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

  4. the Pittsburgh Sleep Quality Index (PSQI) score

    Time frame: At the end of weeks 1, 2, 4, 8, and 12 after treatment

    Sleep quality measured by PSQI score(range 0-21, with higher scores indicating poorer sleep quality)

  5. the Patient Global Impression of Change scale (PGIC)

    Time frame: At the end of weeks 1, 2, 4, 8, and 12 after treatment

    The Patient Global Impression of Change (PGIC) is usually a 7 - point scale. The scale title is "Patient Global Impression of Change". The minimum value is 1 and the maximum value is 7.In summary, for the PGIC scale, lower scores (from 1 to 3) mean a better outcome, indicating improvement in the patient's condition, while higher scores (from 5 to 7) mean a worse outcome, suggesting a deterioration of the condition. Score 4 represents a neutral state of no change.

  6. the Hospital Anxiety and Depression Scale (HADS)

    Time frame: At the end of weeks 1, 2, 4, 8, and 12 after treatment

    It 6.consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression.

  7. Safety assessments

    Time frame: Conducted on Day 0, Day 1, Day 3, and at the end of weeks 1, 2, 4, 8, and 12 after treatment

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

Intravenous Infusion of Esketamine in Combination With Pulsed Radiofrequency for Trigeminal Postherpetic Neuralgia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 9, 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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