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?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Change in pain intensity between baseline and the end of treatment
Study Overview
Brief Summary
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?
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
Outcomes
Primary Outcomes
Change in pain intensity between baseline and the end of treatment
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
Philippe Macaire
Anesthesiologist and Pain physician
Vinmec Healthcare System