Prevention of Post Herpetic Neuralgia by Ultrasound Guided Single Nerve Block in the ED

NCT04530162 | Withdrawn

• 1 other identifier: 2019-09-04
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Herpes zoster causes significant morbidity on over 1 million Americans every year. Although the majority of herpes zoster pain will self-resolve within one week, a significant proportion of patients will develop postherpetic neuralgia (PHN), which is characterized by debilitating pain that persists more than three months after the initial symptoms. Nerve blocks have been previously studied as a method to control herpes zoster pain in outpatient pain clinics and inpatient settings. This study aims to investigate whether emergency department ultrasound guided nerve blocks can prevent PHN and effectively treat acute herpes zoster pain.

Conditions

Pain

Keywords

pain; pain management; herpes zoster; ultrasound; emergency medicine

Outcome Measures

Primary Outcomes (1)

• Incidence of subacute herpetic neuralgia

  The number of new cases of subacute herpetic neuralgia

  1 month

Secondary Outcomes (1)

• Pain Control

  1 month

Other Outcomes (1)

• Incidence of post herpetic neuralgia

  1 month

Study Arms (1)

Emergency Medicine Herpes Zoster Patients

Emergency Medicine adult patients with herpes zoster pain onset within 30 days of characteristic dermatomal herpes zoster rash who receive nerve block using bupivacaine and dexamethasone. The patient will be then started on Acyclovir 800 mg five times daily for seven days. For mild to moderate breakthrough pain, the patient will be prescribed a 5-day course of Tylenol 650 mg and Ibuprofen 400 mg taken up to every 8 hours together. For severe breakthrough pain, the patients will be prescribed a two-day course of 7.5 mg morphine sulfate immediate release to be taken up to every 6 hours. The location of the nerve block and dosage of injected medications will depend on the distribution of the affected dermatome.

Procedure: Ultrasound guided nerve block

Interventions

Ultrasound guided nerve block PROCEDURE

nerve block using bupivacaine and dexamethasone.

Emergency Medicine Herpes Zoster Patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is Maimonides Medical Center emergency department patients older than 18 years of age presenting with acute herpes zoster patient with characteristic dermatomal vesicular skin lesions within 30 days of initial symptoms.

You may qualify if:

• age over 18
• herpes zoster pain
• pain onset within 30 days of characteristic dermatomal herpes zoster rash

You may not qualify if:

• allergic to bupivacaine
• signs of infection over herpes zoster site
• greater than 30 days duration of pain
• pain across more than one dermatome
• pregnant and/or breastfeeding

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pain; Agnosia; Herpes Zoster

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Leily Naraghi, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: October 1, 2021
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)