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

April 27, 2025 updated by: Shirong Tan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group
High-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block
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).
Other: High-Voltage Long-Duration Pulsed Radiofrequency
High-Voltage Long-Duration Pulsed Radiofrequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS
Time Frame: Baseline and on days 1, 3, 7, 30, 90 ,180 post-interventions
0 indicates no pain,1-3 indicate mild pain,4-6 indicate moderate pain, 7-10indicate severe pain.
Baseline and on days 1, 3, 7, 30, 90 ,180 post-interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Zoster Brief Pain Inventory
Time Frame: Baseline and on days 7, 30, 90 ,180 post-interventions
The instrument comprises two validated domains: pain intensity quantification and pain-related functional interference assessment. With higher composite scores (range: 0-20) indicating greater multidimensional health impairment.
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
Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 20, with lower scores indicating better sleep quality, thereby assessing overall sleep status.
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
Analgesic consumption metrics, including frequency of use and morphine equivalent daily dose (MEDD), were recorded to evaluate longitudinal changes in pain intensity."
Baseline and on days 7, 30, 90,180 post-interventions
Adverse event rate
Time Frame: Day 1 post-interventions

Adverse events include:

Surgery-related complications (e.g., pneumothorax, hematoma, wound infection); Complications associated with bupivacaine liposome subcutaneous block, such as: Cardiac adverse events (e.g., arrhythmias, hypotension); Local tissue toxicity (e.g., myonecrosis, neuropathy).
Day 1 post-interventions
Expression levels of interleukin-6 (IL-6)
Time Frame: Baseline and day 1 post-interventions
Interleukin-6 (IL-6) levels are positively correlated with the severity of postherpetic neuralgia (PHN) pain.
Baseline and day 1 post-interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirong Tan

Investigators

  • Principal Investigator: Jie Yuan, Zunyi Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLLY-2024-236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Via email (15085046515@163.com)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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