NCT06914193

Esketamine Combined With PRF of DRG for Postherpetic Neuralgia

Intravenous Infusion of Esketamine in Combination With Pulsed Radiofrequency of Dorsal Root Ganglion for Postherpetic Neuralgia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study aims to determine whether the addition of esketamine to the PRF of DRG regimen can relieve pain in PHN patients. By doing so, the research endeavors to identify a rapid, effective, and safe treatment approach for refractory PHN patients

Conditions

• Postherpetic Neuralgia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2025-04-06
• Last updated: 2025-04-09

Locations

1 site across 1 country: China