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临床试验/NCT07000409
NCT07000409招募中不适用

The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia, a Prospective Randomized Controlled Study.

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5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
40
试验地点
1
主要终点
Pain degree

研究概览

简要总结

To investigate the effectiveness of ultra-Sound guided Erector spinae block (ESB) with Betamethasone as an adjuvant to standard medical protocol in the management of truncal chronic post herpetic neuralgia.

详细描述

Postherpetic neuralgia (PHN) is a syndrome described as zoster-associated pain persisting for more than 3 months after resolution of an initial herpes zoster (HZ) rash ("shingles").[This condition is considered to be the most prevalent and challenging complication associated with HZ infection. According to reports, around 75% of senior patients who contract HZ are likely to experience it. The incidence of it was observed to be 38.1%, 27.0%, and 19.0% at 1 month, 3 months, and 6 months, respectively, following the onset of zoster. Half of the patients who are more than 50 years have the risk of developing PHN. It is noteworthy that the incidence of PHN seems to be on the rise.

Erector spinae plane (ESP) block is one of the newer interfascial techniques where the drug is injected below the erector spinae muscle to spread towards the costotransverse foramina and origin of dorsal and ventral rami where it is supposed to work at the origin of spinal nerves, based on cadaveric and contrast studies. Cadaveric studies have also showed that a block at T5 level is sufficient to have unilateral multi-dermatomal sensory block ranging from T1 to L3. Thus, this block serves the purpose of a paravertebral block without the risk of pleural injury.

Betamethasone is a long-acting corticosteroid with immunosuppressive and anti-inflammatory properties. It can be used topically to manage inflammatory skin conditions such as eczema, and parenterally to manage several disease states including autoimmune disorders. Betamethasone has potent glucocorticoid activity and negligible mineralocorticoid activity. The beneficial effects of injecting steroids could be because of sympathetic blockage, thereby inhibiting vasoconstriction and due to anaesthetization of the dorsal root ganglion and posterior spinal nerve.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients age between 18 and
  • •Patients with American Society of Anesthesiologists (ASA) II and III status.
  • •Patients diagnosed with truncal chronic post herpetic neuralgia( neuropathic pain persistent for more than 3 months from the onset of rash appearance )

排除标准

  • •Patients unable to comprehend the informed consent.
  • •Patients on long term opioid regimens.
  • •Patients with impairment in hepatic (Alanine aminotransferase (ALT) >50 U/L, and/or Aspartate aminotransferase (AST): >45 U/L) or renal functions( creatinine level ≥1.5 mg/dL)
  • •Patients on anti-coagulation regimens.
  • •Patients with coagulation abnormalities (i.e. international normalized ratio (INR) ≥1.5 and/or platelets ≤50000)
  • •Local infection in the site of the block.
  • •Patients with body mass index (BMI) > 35.

研究组 & 干预措施

Med group

Active Comparator

Patients will receive the standard medical regimen alone.

干预措施: Medical management regimen (Other)

Erector spinae plane block group

Experimental

Patients will receive erector spinae plane (ESP) block with betamethasone with standard medical regimen.

干预措施: Erector spinae plane (ESP) block (Other)

结局指标

主要结局

Pain degree

时间窗: 8 weeks after the first clinic visit.

The degree of pain will be obtained and recorded on a numeric rating scale (NRS) with 0=no pain, and 10=Maximum pain intensity. Pain NRS score will be assessed at 2,4,6,8 weeks after the first clinic visit.

次要结局

  • Incidence of side effects(8 weeks after the first clinic visit.)
  • Tramadol consumption in both groups.(8 weeks after the first clinic visit.)

研究者

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

Nada Refaat Eid

Assistant lecturer of Anesthesia, surgical ICU and pain management, Faculty of medicine, Cairo University

Cairo University

研究点 (1)

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