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

Not Applicable

Recruiting

• Conditions: Zoster; Herpes, Trigeminal Neuralgia (Etiology)
• Interventions: Drug: Esketamine group; Drug: PRF group

• Registration Number: NCT06890897
• Lead Sponsor: Beijing Tiantan Hospital

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).

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

Study Timeline

• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-24
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

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

Exclusion Criteria

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

Withdrawal criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esketamine group	Esketamine group	Besides PRF plus standardized treatment, patients will also receive intravenous infusion of Esketamine ;
control group	PRF group	Patients will only receive PRF plus standardized treatment

Primary Outcome Measures

Name	Time	Method
the NRS score at 1 month after treatment.	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 Outcome Measures

Name	Time	Method
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	Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status)
the Pittsburgh Sleep Quality Index (PSQI) score	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）
the Patient Global Impression of Change scale (PGIC)	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
Analgesics consumption	at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment	the type of analgesics and analgesics consumption
Safety assessments	at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months	intraoperative complications, PRF-related complications, Eskatamine-related complications

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China