Actively Recruiting

Phase 4
Age: 40Years - 85Years
All Genders
NCT06959147

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

Led by Shirong Tan · Updated on 2025-05-06

46

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with zoster-associated neuralgia (ZAN)
  • Provided written informed consent voluntarily
  • Inadequate response to pharmacological or other non-surgical therapies or intolerable drug-related adverse effects
  • Herpes zoster lesions involving cranial/cervicocephalic, cervical, thoracic, or lumbar dermatomes
  • Moderate-to-severe pain with a Numerical Rating Scale (NRS) score of 4 or higher at baseline
  • Aged between 40 and 85 years
  • Body weight: male at least 50 kg; female at least 45 kg
Not Eligible

You will not qualify if you...

  • Severe cardiovascular diseases or life-threatening arrhythmias (e.g., heart failure, third-degree atrioventricular block without pacemaker)
  • 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) making patient unfit for 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 treatment)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China, 563000

Actively Recruiting

Loading map...

Research Team

S

Shirong Tan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here