Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia

NCT06914180 | Not Yet Recruiting DMC

• 1 other identifier: KY-2024-332-02-03
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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).

Conditions

Postherpetic; Neuralgia, Trigeminal (Etiology)

Keywords

trigeminal postherpetic neuralgia; esketamine

Outcome Measures

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）

  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

  7-day period

Secondary Outcomes (7)

• average weekly NRS score

  up to 12 weeks

• averaged weekly analgesic consumption

  up to 12 weeks

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

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

• the Pittsburgh Sleep Quality Index (PSQI) score

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

• the Patient Global Impression of Change scale (PGIC)

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

Study Arms (2)

esketamine group

EXPERIMENTAL

In addition to receiving PRF treatment+pregabalin, patients will also undergo a single intravenous infusion of esketamine

Drug: esketamine group

control group

PLACEBO COMPARATOR

patients will receive PRF treatment+pregabalin

Drug: control group

Interventions

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.

Also known as: esketamine+PRF

esketamine group

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.

Also known as: PRF

control group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

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, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

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

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 6, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)