Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia

NCT06914180 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-04-09

No results posted yet for this study

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)

Interventions

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.

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.

Sponsors & Collaborators

  • Beijing Xiaotangshan Hospital

    collaborator OTHER
  • The First Hospital of Fangshan District,Beijing

    collaborator OTHER
  • Beijing Ditan Hospital

    collaborator OTHER
  • Hengshui People's Hospital

    collaborator OTHER
  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-04-01
Completion
2026-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06914180 on ClinicalTrials.gov