Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia

Not Applicable

Not yet recruiting

• Conditions: Postherpetic; Neuralgia, Trigeminal (Etiology)
• Interventions: Drug: esketamine group; Drug: control group

• Registration Number: NCT06914180
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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).

Detailed Description

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

Study Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-31
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-05
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-04-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

1. Obstructive sleep apnoea syndrome;
2. Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of GG.
3. A history of systemic immune diseases, organ transplantation, or cancers;
4. A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;
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.
10. Women who are preparing for pregnancy, in the pregnancy or lactation period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esketamine group	esketamine group	In addition to receiving PRF treatment+pregabalin, patients will also undergo a single intravenous infusion of esketamine
control group	control group	patients will receive PRF treatment+pregabalin

Primary Outcome Measures

Name	Time	Method
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）	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 Outcome Measures

Name	Time	Method
the Patient Global Impression of Change scale (PGIC)	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.
the Hospital Anxiety and Depression Scale (HADS)	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.
average weekly NRS score	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
the 12-item Short-Form Health Survey (SF-12) score	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)
averaged weekly analgesic consumption	up to 12 weeks	averaged weekly consumption per analgesic of each participant
Safety assessments	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
the Pittsburgh Sleep Quality Index (PSQI) score	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)

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China