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

April 24, 2025 updated by: Fang Luo, Beijing Tiantan Hospital

Effect of Intravenous Infusion of Esketamine Combined Pulsed Radiofrequency on Acute/Subacute Zoster-associated Trigeminal Neuralgia

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
        • Contact:

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. 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 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
Besides PRF plus standardized treatment, patients will also receive intravenous infusion of Esketamine ;
Drug: Esketamine group
Patients in the esketamine group will receive intravenous infusion of esketamine besides PRF+standardized treatment.The formula will be intravenous infusion of 0.5mg/kg of esketamine diluted in 50 mL normal saline, starting with intravenous injection of 10 mg of esketamine for 1 minute, and maintaining a dose 8 mg/h.The infusion rate will be adjusted the parameter according to the tolerance of the patients
Other Names:
  • Esketamine + PRF+standardized treatment
Active Comparator: control group
Patients will only receive PRF plus standardized treatment
Drug: PRF group
Patients in the control group will receive PRF+standardized treatment
Other Names:
  • PRF + standardized group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the NRS score at 1 month after treatment.
Time Frame: 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
1-month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the 12-item Short-Form Health Survey (SF-12) score
Time Frame: 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)
at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
Time Frame: 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）
at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the Patient Global Impression of Change scale (PGIC)
Time Frame: 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
at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Analgesics consumption
Time Frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the type of analgesics and analgesics consumption
at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Safety assessments
Time Frame: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months
intraoperative complications, PRF-related complications, Eskatamine-related complications
at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months

Collaborators and Investigators

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

Sponsor

Beijing Tiantan Hospital

Collaborators

Beijing Ditan Hospital
The First Hospital of Fangshan District,Beijing
Hengshui People's Hospital
Beijing Xiaotangshan Hospital

Investigators

  • Principal Investigator: Fang Luo, M.D., Beijing Tiantan 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 (Actual)

April 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2024-332-02-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not yet

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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