Clinical trial NCT06914180: Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia
Official title: Intravenous Infusion of Esketamine in Combination With Pulsed Radiofrequency for Trigeminal Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postherpetic; Neuralgia, Trigeminal (Etiology)
Keywords: trigeminal postherpetic neuralgia
esketamine
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Xiaotangshan Hospital
name: The First Hospital of Fangshan District,Beijing
name: Beijing Ditan Hospital
name: Hengshui People's Hospital
First posted: 2025-04-06
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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）
timeFrame: 7-day period
Secondary outcomes:
measure: average weekly NRS score
timeFrame: up to 12 weeks
measure: averaged weekly analgesic consumption
timeFrame: up to 12 weeks
measure: the 12-item Short-Form Health Survey (SF-12) score
timeFrame: At the end of weeks 1, 2, 4, 8, and 12 after treatment
measure: the Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: At the end of weeks 1, 2, 4, 8, and 12 after treatment
measure: the Patient Global Impression of Change scale (PGIC)
timeFrame: At the end of weeks 1, 2, 4, 8, and 12 after treatment
measure: the Hospital Anxiety and Depression Scale (HADS)
timeFrame: At the end of weeks 1, 2, 4, 8, and 12 after treatment
measure: Safety assessments
timeFrame: Conducted on Day 0, Day 1, Day 3, and at the end of weeks 1, 2, 4, 8, and 12 after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: