NCT06882525

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 7, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 6, 2025

Last Update Submit

March 17, 2025

Conditions

Keywords

Neuralgia, PostherpeticHERPES ZOSTERLidocaine

Outcome Measures

Primary Outcomes (1)

  • NRS , DN4

    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

Study Arms (1)

Patients who are referred from the dermatology clinic or voluntarily present to our pain management

ACTIVE COMPARATOR

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)

Interventions

Lidocain subcuteous infiltratyion will be done to rush area.

Patients who are referred from the dermatology clinic or voluntarily present to our pain management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üniversiteler Mahallesi 1604. Cadde No: 9 Çankaya/ANKARA

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

Related Publications (1)

  • Johnson RW, Alvarez-Pasquin MJ, Bijl M, Franco E, Gaillat J, Clara JG, Labetoulle M, Michel JP, Naldi L, Sanmarti LS, Weinke T. Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Ther Adv Vaccines. 2015 Jul;3(4):109-20. doi: 10.1177/2051013615599151.

    PMID: 26478818BACKGROUND

MeSH Terms

Conditions

Herpes ZosterNeuralgia, Postherpetic

Interventions

LidocainePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Ali Çoştu Çostu, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 18, 2025

Study Start

March 7, 2025

Primary Completion

September 7, 2025

Study Completion

December 6, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Privacy.

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