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Regional Anesthesia to Relief Zoster Pain

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ClinicalTrials.gov Identifier: NCT04133142
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Philippe Macaire, Vinmec Healthcare System

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?

Condition or disease Intervention/treatment Phase
Zoster Without Complications Procedure: peripheral nerve block, inter fascial nerve block Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patient randomized in Medical treatment group or Early block group

  • medical treatment group will have standard pain medications and evaluation of pain relief at day 7

    • If pain reduce less or egal to VAS 4 medical treatment will continue it will be the control group
    • If no pain relief VAS more than 4 patient will be randomized to have

      • single block = Group late block single
      • or repeated blocks = Group late block repeated
  • ealy block group will be randomized to have

    • single block = Group early block single
    • or repeated blocks = Group early block repeated
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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?
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
No Intervention: Medical treatment

Patients receive the standard medical medication for herpes pain

  • Oral administration of Gabapentin

    • 300 mg/d on day 1 and 2
    • 600 mg/d on day 3 and 4 if pain persists
    • 900 mg/d on day 5 and 6 if pain persists
  • Oral administration of Paracetamol up to 3 g per day prescription for 7 day and continue for 3 weeks after evaluation
Experimental: Early block Single
the patient will receive a regional anaesthesia by Inter fascial block, peripheral nerve block. Local anesthetic used will be ropivacaine 0.5% dose according to the type of block and never exceeding 3mg/kg The type of block would be the most appropriate to cover the dermatomes involved in the Herpes according to the mapping done with the higher ration benefit risks. Choice of Block by an anesthesiologist expert in regional anaesthesia techniques. After the block performance if the pain comes back patient will receive the standard medical treatment as in the group medical treatment
Procedure: peripheral nerve block, inter fascial nerve block
regional anaesthesia by Inter fascial block, peripheral nerve block. The type of block would be the most appropriate to cover the dermatomes involved in the Herpes according to the mapping done with the higher ratio benefit risks. The choice of the block will be done by an anesthesiologist expert in regional anaesthesia techniques. local anesthetic will be ropivacaine 0.5% posology according to the type of block

Experimental: Early Repeated block
the patient will receive a regional anaesthesia by Inter fascial block, peripheral nerve block. The type of block would be the most appropriate to cover the dermatomes involved in the Herpes according to the mapping done with the higher ratio benefit risks. Local anesthetic used will be ropivacaine 0.5% dose according to the type of block and never exceeding 3mg/kg The choice of the block will be done by an anesthesiologist expert in regional anaesthesia techniques. The block will be repeated every 48h until the pain will reach VAS < 3 6 h after block recovery.
Procedure: peripheral nerve block, inter fascial nerve block
regional anaesthesia by Inter fascial block, peripheral nerve block. The type of block would be the most appropriate to cover the dermatomes involved in the Herpes according to the mapping done with the higher ratio benefit risks. The choice of the block will be done by an anesthesiologist expert in regional anaesthesia techniques. local anesthetic will be ropivacaine 0.5% posology according to the type of block

Experimental: Late block single

Patients receive the standard medical medication for herpes pain

  • Oral administration of Gabapentin

    • 300 mg/d on day 1 and 2
    • 600 mg/d on day 3 and 4 if pain persists
    • 900 mg/d on day 5 and 6 if pain persists
  • Oral administration of Paracetamol up to 3 g per day at day 7 if pain more than VAS 4 the patient will receive a regional anaesthesia by Inter fascial block, peripheral nerve block . Local anesthetic used will be ropivacaine 0.5% dose according to the type of block and never exceeding 3mg/kg The type of block would be the most appropriate to cover the dermatomes involved in the Herpes according to the mapping done with the higher ration benefit risks. Choice of Block by an anesthesiologist expert in regional anaesthesia techniques. After the block performance if the pain comes back patient will receive the standard medical treatment as in the group medical treatment
Procedure: peripheral nerve block, inter fascial nerve block
regional anaesthesia by Inter fascial block, peripheral nerve block. The type of block would be the most appropriate to cover the dermatomes involved in the Herpes according to the mapping done with the higher ratio benefit risks. The choice of the block will be done by an anesthesiologist expert in regional anaesthesia techniques. local anesthetic will be ropivacaine 0.5% posology according to the type of block

Experimental: late block repeated

Patients receive the standard medical medication for herpes pain

  • Oral administration of Gabapentin

    • 300 mg/d on day 1 and 2
    • 600 mg/d on day 3 and 4 if pain persists
    • 900 mg/d on day 5 and 6 if pain persists
  • Oral administration of Paracetamol up to 3 g per day prescription for 7 day and continue for 3 weeks after evaluation At day 7 if pain more than VAS 4 the patient will receive a regional anaesthesia by Inter fascial block, peripheral nerve block. The type of block would be the most appropriate to cover the dermatomes involved in the Herpes according to the mapping done with the higher ratio benefit risks. Local anesthetic used will be ropivacaine 0.5% dose according to the type of block and never exceeding 3mg/kg The choice of the block will be done by an anesthesiologist expert in regional anaesthesia techniques. The block will be repeated every 48h until the pain will reach VAS < 3 6 h after block recovery.
Procedure: peripheral nerve block, inter fascial nerve block
regional anaesthesia by Inter fascial block, peripheral nerve block. The type of block would be the most appropriate to cover the dermatomes involved in the Herpes according to the mapping done with the higher ratio benefit risks. The choice of the block will be done by an anesthesiologist expert in regional anaesthesia techniques. local anesthetic will be ropivacaine 0.5% posology according to the type of block




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of postherpetic neuralgia (PHN) after treatment [ Time Frame: day 30 - day 60 - day 90 - day 180 ]
    PHN is defined as persisting pain beyond the crusting of cutaneous lesion. Pain lasts more than 1 month after the acute infection with the DN4 scale score > 4 and DetectPain scale score > 19

  2. Chang in quality of life score [ Time Frame: Day 1 day 30 - day 60 - day 90 - day 180 ]

    Using the 36-Item Short-Form Health Survey (SF-36) for quality-of-life measurement. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Higher score defines a more favorable health state.

    The overall quality-of-life score at each time-point will be created from all items using an ad-hoc analysis.


  3. The total pain burden during 180 days of follow-up [ Time Frame: baseline- every 2 days until day 30 - day 60 - day 90 - day 180 ]
    The total pain burden is quantified using an area-under-the-curve (AUC) method, using the measures of pain intensity and pain duration. Each patient's AUC is calculated as the sum of all areas obtained by multiplying the average of 2 consecutive pain scores by the number of days between the scores.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute zona diagnosed by the dermatologist

    o 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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133142


Contacts
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Contact: Philippe Macaire, MD +84966103845 ph.macaire@gmail.com
Contact: chi Nguyen, Msc +84834182013 nguyen.yen.chi123@gmail.com

Sponsors and Collaborators
Vinmec Healthcare System

Publications of Results:
Other Publications:

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Responsible Party: Philippe Macaire, Anesthesiologist and Pain physician, Vinmec Healthcare System
ClinicalTrials.gov Identifier: NCT04133142     History of Changes
Other Study ID Numbers: Zona Blocks
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philippe Macaire, Vinmec Healthcare System:
Zoster,
Pain relief
regional anesthesia
Prevention post herpetic neuralgia
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Anesthetics
Ropivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents