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临床试验/NCT06761924
NCT06761924招募中不适用

Predictors of Response to Ultrasound-Guided Thoracic Paravertebral Nerve Block in Patients With Herpetic Neuralgia

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年2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
招募中
入组人数
140
试验地点
1
主要终点
The Numeric Pain Rating Scale (NRS)

研究概览

简要总结

This study aims to fill the knowledge gap by investigating the predictors of success for TPVB in patients with herpetic neuralgia. By identifying demographic, clinical, previous medications and procedural factors associated with positive outcomes, this research seeks to enhance the efficacy of TPVB and improve pain management strategies for patients suffering from herpetic neuralgia.

详细描述

Herpes zoster (HZ) is characterized by a unilateral dermatomal vesicular rash and severe discomfort along the affected dermatome. It is often caused by the reactivation of previously latent varicella zoster viruses (VZV) in cases of impaired cellular immunity.

According to recent population-based research , the overall incidence of HZ is almost 6.64/1000 person-years in the population aged 50 years or over, and it rises with age.

The most prevalent and severe side effect of HZ is post-herpetic neuralgia (PHN), which is commonly described as pain that lasts for 90 days after the rash first appears. Age-related increases in PHN incidence range from 5 to 30%, with patients over 50 having a higher risk if they have severe acute pain, a rash with many lesions, or strong prodromal symptoms.

Regretfully, there hasn't been a treatment that consistently reduces PHN discomfort up until now. Data from much research showed that patients may have significant clinical and financial burdens as a result of HZ and its consequences.

Analgesics are typically also needed, even though the availability of antiviral medications can speed up the end of viral shedding and quicken the healing of rash. Furthermore, it has no discernible effect on the development of PHN. As a result, it is crucial to start a methodical treatment plan that might have a preventative impact on PHN. It has been demonstrated that paravertebral nerve block is effective in treating acute pain in HZ patients, and it appears to have a greater antiviral treatment-induced reduction in PHN incidence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged from18 to 70 years
  • •Diagnosed with herpetic neuralgia.
  • •Able and willing to provide informed consent.
  • •ASA I - II
  • •One dermatomal affection
  • •Thoracic distribution

排除标准

  • •Contraindications to TPVB as ( Infection at site of injection, empyema , coagulopathy and neoplastic lesion occupying the paravertebral space)
  • •Known allergies to study medications (bupivacaine, Dexamethasone).
  • •Severe comorbidities that could interfere with study participation.

研究组 & 干预措施

TPVB group

Active Comparator

patients will receive ultrasound-guided TPVB with 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone (10 mL volume)

干预措施: Ultrasound-Guided Thoracic Paravertebral nerve block (Procedure)

Control group

Placebo Comparator

ultrasound-guided TPVB with 10 mL of saline without knowing which treatment they are receiving, maintaining blinding throughout the study

干预措施: Ultrasound-Guided Thoracic Paravertebral nerve block (Procedure)

结局指标

主要结局

The Numeric Pain Rating Scale (NRS)

时间窗: baseline , 24 hours , 2 weeks ,6 weeks , 3 months and 6 months post- intervention

The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours. The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours

次要结局

  • Patient satisfaction(24 hours,2 weeks ,6 weeks, 3 months and 6 months post- intervention.)

研究者

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

Dina Mahmoud Fakhry

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Beni-Suef University

研究点 (1)

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