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PainNCT04530162

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

An observational study of Pain, run by Antonios Likourezos at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Pain
What is being tested?
Ultrasound guided nerve block
Type of treatment
Surgery or procedure
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Oct 2021to 10 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Maimonides Medical Center

    Brooklyn, New York, 11219

Other trials in United States

About this study

Official title: Prevention of Post Herpetic Neuralgia by Ultrasound Guided Single Nerve Block in the Emergency Department

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.

Read the detailed description

Study Objectives The goal of this study is to evaluate the rate of PHN development in emergency department patients who receive ultrasound guided nerve blocks using bupivacaine and dexamethasone for acute herpes zoster. The investigators will also study the effectiveness of the block in managing acute herpes zoster pain. The primary outcome is the percentage of patients who have significant herpetic pain at 1 month and 3 months after receiving the nerve block. Secondary outcomes measured are pain scores at 1 hour, 1 month, and 3 months post-nerve block. The amount of opioids used after discharge as well as the number of return visits for herpetic pain will also be recorded.

Hypothesis The hypothesis is that patients who receive nerve blocks will decrease the occurrence of PHN development at 1 month and 3 months post-treatment. The secondary hypothesis is that nerve blocks will decrease pain scores at 1 hour, 1 month, 3 months, as well as reduce the amount of opioids used and number of return visits for herpetic pain.

IStudy Design This study will be a single center prospective observational study that will be conducted in the emergency department of an urban hospital center. A trained emergency medicine physician will screen and assess the patient for eligibility. Once the patient is determined to be eligible, informed consent will be obtained. A trained EM physician will then administer a nerve block using bupivacaine and dexamethasone to a patient with acute herpes zoster. The patient will be 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. The dermatomal distributions with their associated nerve blocks and medication dosages are shown the table below.

Herpes Zoster Distribution Nerve Block Type Medication T2-T9 Serratus Plane 30 mL 0.25% bupivacaine and 8 mg Dexamethasone C2-C3 Greater Occipital Nerve 2 mL 0.25% bupivacaine and 4 mg dexamethasone C3-C4 Superficial Cervical Plexus 10 mL 0.25% bupivacaine and 4 mg dexamethasone Anterior Abdominal Wall T6 - L1 Transversus Abdominis Plane 30 mL 0.25% bupivacaine and 8 mg dexamethasone

A numerical verbal rating scale will be used to assess the patient's pain pre-injection and at 1-hour post nerve block. We will then call the patient at the 1 week, 1 month, and 3-month post-nerve block time intervals to assess the patients' pain. The investigators will also record the number of follow-up visits for herpetic pain and the amount of additional pain medications used.

When called the patient will be asked a series of questions:

  1. Do you continue to have pain associated with your herpes zoster infection?
  2. If so, how would you rate your pain from a scale of 0-10? 10 being the worst pain you have ever had in your life.
  3. About how much pain medication have you been using since the initial nerve block? How many doses of Ibuprofen or Tylenol per day for how many days? How many doses of morphine sulfate immediate release or other opioids were taken per day for how many days?
  4. If you used other forms of pain controllers, what were they and how often and for how long did you use them?
  5. Have you seen your primary care doctor, pain clinic, emergency department, or other pain management follow-up visits for management of your herpes pain? If so, how many visits have you made?
  6. What side effects have you had since the nerve block?

Subjects:

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.

Design:

The primary outcome is the percentage of patients who have significant herpetic pain at 1 month and 3 months after receiving the nerve block. Secondary outcomes measured are pain scores pre-injection, and 1 hour, 1 month, and 3 months post-nerve block. The number of tablets of opioids and other analgesics used after discharge as well as the number of return visits for herpetic pain will also be recorded.

Data Collection Procedures:

The numerical verbal rating scale pain score will be recorded by a research staff member at 1 hour after administration of nerve block. The patients will then be called at 1 week, 1 month, and 3 months post nerve block for assessment of NRS as well as number of follow-up visits and amount of analgesics used. A medication track form/log will be given to the patients to help record the amount of medications taken in the first week. The patients will be stratified by age: those under 50, 50-59, 60-69, and 70 and older as well as herpes zoster vaccination status.

Expected Outcomes:

The investigators expect that patients undergoing ultrasound guided nerve block will have decreased incidence of subacute herpetic neuralgia and PHN. We also expect pain to be well controlled at 1 hour, 1 week, 1 month, and 3 months post nerve block.

Conditions
Pain
Being tested
Ultrasound guided nerve block
Keywords
pain, pain management, herpes zoster, ultrasound, emergency medicine
Medical subject headings
Pain, Agnosia, Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided nerve blockProcedure or surgery

    nerve block using bupivacaine and dexamethasone.

Study groups in NCT04530162
Study groupRoleWhat they receive
Emergency Medicine Herpes Zoster PatientsEmergency 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.
Receives: Procedure: Ultrasound guided nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of subacute herpetic neuralgia

    The number of new cases of subacute herpetic neuralgia

    Measured: 1 month

Secondary outcomes (1)
  1. Pain Control

    Pain score on an 11 point Likert scale ranging from 0 to 10 where 0 is no pain, 5 is moderate pain and 10 is very severe pain.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start1 Oct 2021
  3. Primary completion10 Jun 2022
  4. Study completion10 Jun 2022

Why it stopped: No patients qualified for the study; PI left institution and current investigators lost interest in the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04530162
Sponsor's protocol ID
2019-09-04
Status last verified
Jun 2022
First submitted
25 Aug 2020
Last updated
16 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, run by Antonios Likourezos at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of subacute herpetic neuralgia (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.

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