High-Voltage Long-Duration Pulsed Radiofrequency Combined With Liposomal Bupivacaine Subcutaneous Block for Herpes Zoster-Associated Neuralgia

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
China
Affiliated Hospital of Zunyi Medical University
RECRUITING
Zunyi
Contact Information
Primary
Shirong Tan
15085046515@163.com
+8615085046515
Time Frame
Start Date: 2024-12-17
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 46
Treatments
Experimental: HL-PRF+LB group
After high-voltage pulsed radiofrequency (HL-PRF) treatment targeting the dorsal root ganglion (DRG), a local anesthetic (Liposomal bupivacaine) was administered via subcutaneous injection at the painful lesion site 2 hours post-procedure.
Other: 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).
Sponsors
Leads: Shirong Tan

This content was sourced from clinicaltrials.gov