Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia

April 5, 2025 updated by: Fang Luo, Beijing Tiantan Hospital

Intravenous Infusion of Esketamine in Combination With Pulsed Radiofrequency for Trigeminal Postherpetic Neuralgia

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: esketamine group
In addition to receiving PRF treatment+pregabalin, patients will also undergo a single intravenous infusion of esketamine
Drug: esketamine group
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.
Other Names:
  • esketamine+PRF
Placebo Comparator: control group
patients will receive PRF treatment+pregabalin
Drug: control group
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.
Other Names:
  • PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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）
Time Frame: 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
7-day period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessments
Time Frame: 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
Conducted on Day 0, Day 1, Day 3, and at the end of weeks 1, 2, 4, 8, and 12 after treatment
averaged weekly analgesic consumption
Time Frame: up to 12 weeks
averaged weekly consumption per analgesic of each participant
up to 12 weeks
the 12-item Short-Form Health Survey (SF-12) score
Time Frame: 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)
At the end of weeks 1, 2, 4, 8, and 12 after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
Time Frame: 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)
At the end of weeks 1, 2, 4, 8, and 12 after treatment
the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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.
At the end of weeks 1, 2, 4, 8, and 12 after treatment
average weekly NRS score
Time Frame: 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
up to 12 weeks
the Patient Global Impression of Change scale (PGIC)
Time Frame: 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.
At the end of weeks 1, 2, 4, 8, and 12 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

Beijing Ditan Hospital
Beijing Xiaotangshan Hospital
Beijing Fangshan District of First Hospital
Halison International Peace Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2024-332-02-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not yet decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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