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临床试验/NCT04133142
NCT04133142撤回不适用

Does Repetitive Peripheral Nerve Blocks Vs Single Peripheral Nerve Block Vs Standard Medical Treatment Provide a Better Pain Relief on Zoster Pain at the Acute Phase and Reduce the Risk of Post Herpetic Neuralgia?

Vinmec Healthcare System1 个研究点 分布在 1 个国家开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Change in pain intensity between baseline and the end of treatment

研究概览

简要总结

Pain in Herpes is a serious issue for patients. at the acute phase it is a moderate to severe pain . 30% patients will develop a post herpetic neuralgia this percentage up to 70 % after 60 years old. this post herpetic neuralgia will affect their life. Publication showed the efficiency of regional anesthesia on pain at the acute phase and a recent meta-analysis showed the role of efficient pain relief on the prevention of post herpetic neuralgia. there are still 2 questions to answer: 1/ do we need to perform the regional anesthesia to relief the pain at an early stage of after no response to the medical treatment? 2/ Are repeated blocks more efficient than a single block?

详细描述

Study Model:

Randomized prospective registered After approval by the ethical committee of VinMec international Hospitals Institution , after approved registration prior to start the study to www.clinicaltrial.gov, 80 patients will be enrolled to participate to the study.

Inclusion criteria; Acute zona diagnosed by the dermatologist Acute skin rash with blisters in a limited area on one side of the body Eruption Unilateral On dermatome between C5 and S2 Age 18 to 85 years Old [YO], males and females American Society of Anesthesiologists score [ASA] grades I & II Patient who accepted to participate as volunteers and signed an informed consent

Exclusion criteria; Psychiatric disease Central nervous system disease or pre-existing neuropathy Coagulation abnormalities or anti-coagulant treatment (heparins Anti vit K anti thrombin) Contra indication to perform a peripheral nerve block or interfascial block Infection of the skin overlying the puncture site of the block Allergy to local anaesthetic or prednisolone Contra indication to prednisolone ASA III and IV Morbidity Obese BMI > 30 Pregnant woman Baseline evaluation; Date of first rash appeared Pain VAS score from 0 no Pain to 10 the worst imaginable pain Localization of the pain (Skin mapping of the painful area and allodynia area) Quality of life before the rash evaluated by the quality of Life questionnaire SF36 published with a certified translation in Vietnamese As soon as the diagnosis will be done by dermatologist the following treatment will be prescribed according to international published standards of Herpes; Oral administration of Acyclovir 800 mg 5 times a day for 7 days Oral administration of prednisolone except if contra indication 30mg twice daily on d1 > 7 15mg twice daily on d8 > 14 7.5mg twice daily on d15 > 21

Patient flow chart:

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute zona diagnosed by the dermatologist
  • o Acute skin rash with blisters in a limited area on one side of the body
  • Unilateral
  • On dermatome between C5 and S2
  • Age 18 to 85 years old, males and females
  • American Society of Anesthesiologists Score [ASA ]grades I & II
  • Patient who accepted to participate as volunteers and signed an informed consent

排除标准

  • Psychiatric disease
  • Central nervous system disease or pre-existing neuropathy
  • Coagulation abnormalities or anti-coagulant treatment (heparins Anti vit K anti thrombin)
  • Contra indication to perform a peripheral nerve block or interfascial block
  • Infection of the skin overlying the puncture site of the block
  • Allergy to local anaesthetic or prednisolone
  • Contra indication to prednisolone
  • ASA III and IV
  • Morbidity Obese BMI > 30
  • Pregnant woman

结局指标

主要结局

Change in pain intensity between baseline and the end of treatment

时间窗: baseline - end of treatment at day 30

Measure by change in the numeric Visual Analogue Scale (VAS) score. The pain-VAS is a single-item scale which is score from 0 -10. A higher score indicates greater pain intensity (0 = "no pain" and 10 = "worst pain imaginable") 0 is the best score 10 is the worse one

次要结局

  • Incidence of postherpetic neuralgia (PHN) after treatment(day 30 - day 60 - day 90 - day 180)
  • Chang in quality of life score(Day 1 day 30 - day 60 - day 90 - day 180)
  • The total pain burden during 180 days of follow-up(baseline- every 2 days until day 30 - day 60 - day 90 - day 180)

研究者

发起方
Vinmec Healthcare System
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philippe Macaire

Anesthesiologist and Pain physician

Vinmec Healthcare System

研究点 (1)

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