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临床试验/NCT06882525
NCT06882525已完成不适用

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

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
NRS , DN4

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Lidocaine (drug) (Procedure)

结局指标

主要结局

NRS , DN4

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali ÇOŞTU

Medical doctor

Ankara City Hospital Bilkent

研究点 (1)

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