Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia
NCT06914180 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174
Last updated 2025-04-09
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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