Esketamine Combined With PRF of DRG for Postherpetic Neuralgia

NCT06914193 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

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) of dorsal root ganglion(DRG) against that of PRF monotherapy in patients with postherpetic neuralgia(PHN).

Conditions

  • Postherpetic Neuralgia

Interventions

DRUG

esketamine+PRF treatment group

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

DRUG

PRF treatment group

In the control group, patients will receive PRF treatment. PRF will be performed on DRG by an designated physician in each participating center. The patients will be treated with PRF (PMG-230, Baylis Medical Inc.) using a 21-gauge sterilized radiofrequency needle (a 10-cm trocar with a 5-mm active tip, PMF-21-100-5, Baylis Medical Inc.), which will be carefully inserted until the needle tip reached the upper edge of the intervertebral foramen under the guidance of three-dimensional (3D) CT. PRF treatment (PMG-230, Baylis Medical Inc.) targeting to DRG 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
2026-07-01
Completion
2026-10-01

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 NCT06914193 on ClinicalTrials.gov