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Liposomal Bupivacaine + HL-PRF for Zoster-Associated Neuralgia
NCT06959147Phase 4
Key facts
- Status
- Recruiting
- Start
- Dec 2024
- Primary completion
- Dec 2025
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- postherpetic neuralgia (PHN)
01
Overview
Phase 4, randomised trial of liposomal bupivacaine in postherpetic neuralgia (PHN) (2 arms). Primary endpoint: Numerical Rating Scale at Day 180. Started Dec 2024; status: recruiting.
02
Design
2 arms- Study design
- Randomized
HL-PRF + LB
High-Voltage Long-Duration Pulsed Radiofrequency followed by Liposomal Bupivacaine subcutaneous injection.
HL-PRF
High-Voltage Long-Duration Pulsed Radiofrequency alone.
03
Who it enrols
Patients aged 40-85 with zoster-associated neuralgia (NRS >= 4) who have had inadequate response to prior pharmacological or non-surgical therapies. Excludes patients with severe cardiovascular disease, coagulation disorders, or prior neuromodulation therapy.
04
Endpoints
Primary
Numerical Rating Scale
Secondary
Zoster Brief Pain Inventory
Pittsburgh Sleep Quality Index
Use of analgesics
Adverse event rate
Interleukin-6 expression levels
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