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.
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.
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:
- Do you continue to have pain associated with your herpes zoster infection?
- 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.
- 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?
- If you used other forms of pain controllers, what were they and how often and for how long did you use them?
- 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?
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ultrasound guided nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subacute herpetic neuralgia
The number of new cases of subacute herpetic neuralgia
Measured: 1 month
Secondary outcomes (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.
- First posted28 Aug 2020
- Study start1 Oct 2021
- Primary completion10 Jun 2022
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Leily Naraghi, MD, Principal investigator, Maimonides Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post Herpetic Neuralgia by Ultrasound Guided Single Nerve Block in the Emergency Department
- ClinicalTrials.gov ID
- NCT04530162
- Acronym / sponsor ID
- 2019-09-04
- Conditions
- Pain
- Keywords
- pain, pain management, herpes zoster, ultrasound, emergency medicine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients qualified for the study; PI left institution and current investigators lost interest in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Do you continue to have pain associated with your herpes zoster infection?
- 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.
- 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?
- If you used other forms of pain controllers, what were they and how often and for how long did you use them?
- 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?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Medicine Herpes Zoster Patients | – | Procedure: Ultrasound guided nerve blockEmergency 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (3 listed)
- age over 18
- herpes zoster pain
- pain onset within 30 days of characteristic dermatomal herpes zoster rash
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided nerve blocknerve block using bupivacaine and dexamethasone. | Procedure or surgery | Emergency Medicine Herpes Zoster Patients |
Primary outcome
Incidence of subacute herpetic neuralgia
Time frame: 1 month
The number of new cases of subacute herpetic neuralgia
1 secondary outcome
Pain Control
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leily Naraghi, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
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.