High-Voltage Long-Duration Pulsed Radiofrequency Combined With Liposomal Bupivacaine Subcutaneous Block for Herpes Zoster-Associated Neuralgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group, High-Voltage Long-Duration Pulsed Radiofrequency.
- Who it may be relevant to
- Registry conditions: Herpes Zoster Pain, Neuralgia, Postherpetic. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Research Objectives Background and Significance: Zoster-associated neuralgia (ZAN) refers to neuropathic pain experienced by herpes zoster (HZ) patients before, during, and after rash resolution, characterized by paroxysmal, lightning-like, or knife-like sensations. Postherpetic neuralgia (PHN), a common type of chronic pain, is often accompanied by physical-psychological impairments, social dysfunction, and anxiety-depression. While high-voltage long-term pulsed radiofrequency (HL-PRF) has become a conventional treatment for ZAN, it is limited by residual postoperative localized pain and suboptimal efficacy for refractory cases. Liposomal bupivacaine (LB), a sustained-release analgesic providing up to 72 hours of pain relief, offers potential for combined subcutaneous injection to enhance symptomatic control. Study Process: This clinical study focuses on evaluating the efficacy of HL-PRF combined with LB subcutaneous injection in treating ZAN. The trial will be conducted from December 16, 2024, to December 14, 2026, with an anticipated enrollment of 92 participants. Patients will be randomized into two groups: HL-PRF group: Under CT-guided localization, high-voltage pulsed radiofrequency (HL-PRF) therapy was precisely delivered to the pathologically compromised dorsal root ganglion (DRG). HL-PRF+LB group: HL-PRF treatment followed by LB subcutaneous injection at the painful lesion site 2 hours post-procedure. Clinical data will be collected preoperatively, and inflammatory factors will be assessed on the first postoperative day. Follow-up evaluations via telephone will occur at 1 week, 1 month, 3 months, and 6 months postoperatively. By analyzing changes in observed indicators before and after treatment, this study aims to determine the clinical efficacy of combining HL-PRF with LB subcutaneous injection for ZAN.
Interventions
- Drug High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group
High-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block - Other High-Voltage Long-Duration Pulsed Radiofrequency
High-Voltage Long-Duration Pulsed Radiofrequency
Primary outcome measures
- NRS [Time frame: Baseline and on days 1, 3, 7, 30, 90 ,180 post-interventions]
Secondary outcome measures (5)
- The Zoster Brief Pain Inventory [Time frame: Baseline and on days 7, 30, 90 ,180 post-interventions]
- Pittsburgh Sleep Quality Index Scale [Time frame: Baseline and on days 7, 30, 90 ,180 post-interventions]
- Use of analgesics (tramadol, gabapentin, or pregabalin) [Time frame: Baseline and on days 7, 30, 90,180 post-interventions]
- Adverse event rate [Time frame: Day 1 post-interventions]
- Expression levels of interleukin-6 (IL-6) [Time frame: Baseline and day 1 post-interventions]
Eligibility criteria
Inclusion criteria
Patients diagnosed with zoster-associated neuralgia (ZAN) who meet ALL of the following conditions:
- Voluntarily provided written informed consent.
- Inadequate response to pharmacological or other non-surgical therapies OR intolerable drug-related adverse effects.
- Herpes zoster (HZ) lesions involving cranial/cervicocephalic, cervical, thoracic, or lumbar dermatomes.
- Moderate-to-severe pain intensity, defined as a Numerical Rating Scale (NRS) score ≥4 at baseline.
- Aged between 40 and 85 years.
- Body weight: Male ≥50 kg; female ≥45 kg.
Exclusion criteria
- Severe cardiovascular diseases or life-threatening arrhythmias (e.g., heart failure, third-degree atrioventricular block without pacemaker implantation).
- Contraindications to minimally invasive interventions (e.g., coagulation disorders, active infections).
- Allergy to local anesthetics or lipid emulsions; Severe dysfunction of vital organs (cardiac, pulmonary, hepatic, or renal) rendering the patient unfit for the procedure.
- Severe endocrine disorders or long-term use of corticosteroids/immunosuppressive agents.
- Cognitive impairment or inability to cooperate with treatment protocols.
- Prior history of neuromodulation therapies (e.g., spinal cord stimulation or pulsed radiofrequency (PRF) treatment).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated Hospital of Zunyi Medical University — Zunyi
Identifiers
NCT: NCT06959147 · KLLY-2024-236