Regional Anesthesia to Relief Zoster Pain

NCT04133142 | Withdrawn DMC

• 1 other identifier: Zona Blocks
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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?

Conditions

Zoster Without Complications

Keywords

Zoster,; Pain relief; regional anesthesia; Prevention post herpetic neuralgia

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity between baseline and the end of treatment

  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

  baseline - end of treatment at day 30

Secondary Outcomes (3)

• 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

Study Arms (5)

Medical treatment

NO INTERVENTION

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

Early block Single

EXPERIMENTAL

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

Early Repeated block

EXPERIMENTAL

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

Late block single

EXPERIMENTAL

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

late block repeated

EXPERIMENTAL

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

Interventions

peripheral nerve block, inter fascial nerve block PROCEDURE

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

Early Repeated block; Early block Single; Late block single; late block repeated

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vinmec Healthcare System: lead

Study Sites (1)

Vinmec Health System

Hanoi, Vietnam

Location

Related Publications (31)

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MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist and Pain physician

Model Details: 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

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 21, 2019
• Study Start: May 15, 2020
• Primary Completion: November 12, 2022
• Study Completion: November 12, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)