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临床试验/NCT04656821
NCT04656821Unknown4 期

Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Thoracic Paravertebral Block for Pain Relief in Patients With Acute Thoracic Herpes Zoster

Tanta University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年12月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
90
试验地点
1
主要终点
The incidence of post herpetic neuralgia (PHN)

研究概览

简要总结

The aim of this research is to study and compare the efficacy and safety of single injection erector spinae plane block and thoracic paravertebral block in prevention of post herpetic neuralgia in patients with acute thoracic herpes zoster.

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
51 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 50 years of age
  • Chest wall herpetic eruption of less than one week
  • Moderate or severe pain

排除标准

  • Patient refusal
  • Eruption more than one week duration
  • Patients who will not receive appropriate anti-viral therapy
  • Patients with mild pain
  • Infection at the site of injection
  • Patients with a history of renal, hepatic diseases, coagulopathy, steroid therapy, malignancies.
  • Patient taking chemotherapy and/or radiotherapy.

研究组 & 干预措施

Control Group

Active Comparator

Patients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed.

干预措施: Control Rx (Drug)

Erector Spinae Block (ESB) group

Experimental

Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography. The concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography.

干预措施: Erector Spinae Block (Procedure)

Thoracic Paravertebral Block group

Experimental

Patients will receive 25 mg bupivacaine 0.5%, plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at the desired level under ultrasonography

干预措施: Thoracic Paravertebral Block (Procedure)

结局指标

主要结局

The incidence of post herpetic neuralgia (PHN)

时间窗: 3 months

Persistent herpetic pain after 3 months will reported as post herpetic neuralgia (PHN)

次要结局

  • Visual Analog Scale(6 months)
  • Total consumption of rescue analgesia(6 months)
  • The times of complete resolution of pain(3 months)
  • Adverse effects and complications(1 day)

研究者

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

Esraa Hassan Abdelwahab

Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

研究点 (1)

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