Herpes ZosterSCL-HZ/PHNNCT06882525
Subcutaneous Lidocaine Injection in Acute Herpes Zoster Neuralgia and Post-herpetic Neuralgia
A study testing Lidocaine (drug) in people with Herpes Zoster and Neuralgia, Postherpetic, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster, Neuralgia, Postherpetic
- What is being tested?
- Lidocaine (drug)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over the age of 18
- with acute HZ pain (rash duration < 30 days
- pain due to PHN (rash duration > 3 months),
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Üniversiteler Mahallesi 1604. Cadde No: 9 Çankaya/ANKARA
Ankara, Cankaya, 06800
About this study
Official title: 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
Read the 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.
- Conditions
- Herpes Zoster, Neuralgia, Postherpetic
- Being tested
- Lidocaine (drug)
- Keywords
- Neuralgia, Postherpetic, HERPES ZOSTER, Lidocaine
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine (drug)Procedure or surgery
Lidocain subcuteous infiltratyion will be done to rush area.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Lidocaine (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st week after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Apr 2025
- Primary completion1 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali ÇOŞTU, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882525
- Sponsor's protocol ID
- E2-25-9924
- Acronym
- SCL-HZ/PHN
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy.
Publications
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.
PubMed 26478818
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effectiveness of Subcutaneous Lidocaine Injection in Acute Herpes Zoster Neuralgia and Post-herpetic Neuralgia
- ClinicalTrials.gov ID
- NCT06882525
- Acronym / sponsor ID
- SCL-HZ/PHN / E2-25-9924
- Conditions
- Herpes Zoster, Neuralgia, Postherpetic
- Keywords
- Neuralgia, Postherpetic, HERPES ZOSTER, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who are referred from the dermatology clinic or voluntarily present to our pain management | Active comparator | Procedure: Lidocaine (drug)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over the age of 18
- with acute HZ pain (rash duration < 30 days
- pain due to PHN (rash duration > 3 months),
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine (drug)Lidocain subcuteous infiltratyion will be done to rush area. | Procedure or surgery | Patients who are referred from the dermatology clinic or voluntarily present to our pain management |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Results publication: PubMed 26478818Johnson 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.
- Individual participant dataSharing planned: No. Privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine (drug) in people with Herpes Zoster and Neuralgia, Postherpetic, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS , DN4 (time frame: 1st week after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06882525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.