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

NCT ID: NCT06959147

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-17
• Study Completion Date: 2026-05-31

Brief 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.

Conditions

Herpes Zoster Pain; Neuralgia, Postherpetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group

Intervention Type: DRUG

High-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block

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).

Group Type: OTHER

High-Voltage Long-Duration Pulsed Radiofrequency

Intervention Type: OTHER

High-Voltage Long-Duration Pulsed Radiofrequency

Interventions

High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group

High-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block

Intervention Type: DRUG

High-Voltage Long-Duration Pulsed Radiofrequency

High-Voltage Long-Duration Pulsed Radiofrequency

Intervention Type: OTHER

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirong Tan

OTHER

Sponsor Role: lead

Responsible Party

Shirong Tan

Attending Physician in Pain Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jie Yuan

Role: PRINCIPAL_INVESTIGATOR

Zunyi Medical College

Locations

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shirong Tan

Role: CONTACT

15085046515@163.com

+8615085046515

Facility Contacts

Shirong Tan

Role: primary

15085046515@163.com

+8615085046515

Other Identifiers

KLLY-2024-236

Identifier Type: -

Identifier Source: org_study_id