Subcutaneous Lidocaine Injection in Acute Herpes Zoster Neuralgia and Post-herpetic Neuralgia (SCL-HZ/PHN)

March 17, 2025 updated by: Ülkü Sabuncu, Ankara City Hospital Bilkent

The Evaluation of the Effectiveness of Subcutaneous Lidocaine Injection in Acute Herpes Zoster Neuralgia and Post-herpetic Neuralgia

In this study, it was aimed to compare the effect of subcutaneous lidocaine injection, which is routinely applied in pain clinic,in patients who present with pain complaints due to acute herpes zoster and post-herpetic neuralgia, and investigate its contribution to preventing the development of post-herpetic neuralgia

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Herpes zoster (HZ; shingles) is a disease associated with inflammation of peripheral nerves, which can progress with acute and chronic pain, and is considered a significant cause of postherpetic neuralgia (PHN). The varicella-zoster virus (VZV) causes a primary infection known as chickenpox. The virus then migrates to spinal and cranial sensory ganglia, becoming latent through nerve axons and possibly via viremia from the skin lesions. In some individuals later in life, the virus reactivates, causing a secondary infection known as HZ. When the virus reactivates, it progresses along the affected sensory nerve, causing neuronal damage, and reaches the corresponding dermatome of the skin, leading to vesicular rashes and pain (1). There are three stages of HZ pain: the acute pain phase (up to one month), the subacute pain phase (30-90 days after lesion healing), and the PHN phase (pain lasting more than 90 days after the rash begins) (2).

Since herpes zoster can be very painful, adequate pain control is essential. The acute neuralgia of HZ typically presents as acute pain in the relevant dermatome, ranging from mild itching, tingling, and allodynia to severe pain, which often occurs before the skin lesions. For mild to moderate pain in acute HZ, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or tramadol can be considered. For moderate pain, opioids such as morphine or oxycodone may be administered. If moderate pain is not controlled by opioids, gabapentin or pregabalin, tricyclic antidepressants, or corticosteroids may be considered as additional treatments (3). Furthermore, in acute HZ, intradermal infiltration of local anesthetics and corticosteroids has been shown to be effective in reducing pain and preventing the development of PHN (4).

The pharmacological treatment of PHN includes a variety of medications such as alpha-2 delta ligands (gabapentin and pregabalin), other anticonvulsants (carbamazepine), tricyclic antidepressants (amitriptyline, nortriptyline), topical analgesics (5% lidocaine patch, capsaicin), tramadol, or other opioids (5). Repetitive intradermal administration of lidocaine and steroids is also used in the treatment of PHN (4).

In this study, it was aimed to demonstrate the effect of subcutaneous lidocaine injection, which is routinely administered in pain clinic, in patients presenting with pain due to acute HZ and PHN, compare its effects in the acute and chronic stages, and investigate its contribution to preventing the development of PHN. The study design and potential risks are explained in the relevant sections.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

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

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06800
        • Üniversiteler Mahallesi 1604. Cadde No: 9 Çankaya/ANKARA

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 over the age of 18
  • with acute HZ pain (rash duration < 30 days
  • pain due to PHN (rash duration > 3 months),

Exclusion Criteria:

patients on anticoagulants or have coagulation disorders, patients with psychomotor disorders patients with uncontrolled diabetes patients with bacterial infection or infectious discharge in the affected dermatomal region patients allergic to lidocaine patients with lesions in the facial or genital regions pregnant or breastfeeding patients

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients who are referred from the dermatology clinic or voluntarily present to our pain management
The result of the study will provide insight into how much subcutaneous lidocaine injection, applied to patients with pain due to acute HZ and PHN, reduces pain, compare the effectiveness between its application in the acute and chronic phases, and determine its contribution to preventing the development of PHN. Based on the outcome, the effectiveness of this treatment can be demonstrated.
Procedure: Lidocaine (drug)
Lidocain subcuteous infiltratyion will be done to rush area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS , DN4
Time Frame: 1st week after injection
The patients' pain scores will be assessed before treatment using the NRS (Numerical Rating Scale) and DN4 (Douleur Neuropathique en 4 Questions) pain scales. During the treatment process, patients will receive three injections, one week apart, and the NRS and DN4 pain scores will be reassessed one week after each injection.
1st week after injection

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

March 7, 2025

Primary Completion (Estimated)

September 7, 2025

Study Completion (Estimated)

December 6, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-25-9924

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Privacy.

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.

No

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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