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

NCT06890897 | Recruiting DMC

• 1 other identifier: KY-2024-332-02-01
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Zoster; Herpes, Trigeminal Neuralgia (Etiology)

Keywords

acute/subacute zoster-associated trigeminal neuralgia; esketamine; pulsed radiofrequency

Outcome Measures

Primary Outcomes (1)

• the NRS score at 1 month after treatment.

  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

  1-month period

Secondary Outcomes (5)

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

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

• the Pittsburgh Sleep Quality Index (PSQI) score

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

• the Patient Global Impression of Change scale (PGIC)

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

• Analgesics consumption

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

• Safety assessments

  at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months

Study Arms (2)

Esketamine group

EXPERIMENTAL

Besides PRF plus standardized treatment, patients will also receive intravenous infusion of Esketamine ;

Drug: Esketamine group

control group

ACTIVE COMPARATOR

Patients will only receive PRF plus standardized treatment

Drug: PRF group

Interventions

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

Also known as: Esketamine + PRF+standardized treatment

Esketamine group

PRF group DRUG

Patients in the control group will receive PRF+standardized treatment

Also known as: PRF + standardized group

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Xiaotangshan Hospital: collaborator
• The First Hospital of Fangshan District,Beijing: collaborator
• Beijing Ditan Hospital: collaborator
• Hengshui People's Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100050, China

RECRUITING

MeSH Terms

Conditions

Herpes Zoster; Herpes Simplex; Trigeminal Neuralgia

Interventions

Esketamine; Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Fang Luo, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Luo, M.D.

CONTACT

+86 13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Day surgery and Pain Management Affiliation

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 24, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)