NCT06914180

Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (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) against that of PRF monotherapy in patients with trigeminal postherpetic neuralgia (TPHN).

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

Conditions

• Postherpetic; Neuralgia, Trigeminal (Etiology)

Interventions

Type	Name	Description
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.

Timeline

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

Locations

1 site across 1 country: China