The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia, a Prospective Randomized Controlled Study.
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
Patients will receive the standard medical regimen alone.
干预措施: Medical management regimen (Other)
Erector spinae plane block group
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
Nada Refaat Eid
Assistant lecturer of Anesthesia, surgical ICU and pain management, Faculty of medicine, Cairo University
Cairo University
