Acute Herpes Zoster NeuropathyNCT06476080
Ultrasound Guided Serratus Anterior Versus Erector Spinae Block in Pain Alleviation in Acute Herpes Zoster
A study testing ultrasound guided erector spine block and Serratus anterior block in people with Acute Herpes Zoster Neuropathy, run by Minia University.
Trial summary
Acute herpes zoster pain is very severe . Conventional analgesics may be of no value. Regional blocks may play a role Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Acute Herpes Zoster Neuropathy
- What is being tested?
- ultrasound guided erector spine block and Serratus anterior block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2024to 15 Apr 2025
- Phase
- Interventional
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult population between 30 and 75 years old.
- Unilateral painful thoracic herpetic eruption of less than one week duration.
- VAS more than or equal 4, persistent pain in spite of proper antiviral and analgesic therapy, (800 mg oral acyclovir, 5 times per day, for one week), pregabalin 300 mg per day, acetaminophen 1000 mg per day, topical calamine lotion).
Who cannot join
- Diabetic patients.
- Painful herpetic eruptive vesicles more than one week.
- Abdominal herpetic eruptions.
- Non-compliant on anti-viral (bulbar palsy for example).
- Co-malignancy or radiotherapy.
- Steroid therapy > 5 mg prednisolone or its equivalent.
- Infections or hematoma at site of injection.
- Coagulopathy (chronic kidney or liver disease, clopidogrel use).
About this study
Official title: Ultrasound Guided Serratus Anterior Versus Erector Spinae Block in Pain Alleviation in Acute Herpes Zoster: A Prospective Comparative Study
Acute herpes zoster pain is very severe . Conventional analgesics may be of no value. Regional blocks may play a role
- Conditions
- Acute Herpes Zoster Neuropathy
- Being tested
- ultrasound guided erector spine block, Serratus anterior block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided erector spine blockProcedure or surgery
Ultrasound guided thoracic erector spinae block
Serratus anterior blockProcedure or surgery
Ultrasound guided serratus anterior block
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion) |
| Erector spinae group | Active comparator | 800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion)+ 25 ml bupivacaine 0.25% plus 8 mg dexamethasone Receives: Procedure: ultrasound guided erector spine block |
| Serratus anterior group | Active comparator | 800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion)+ 25 ml bupivacaine 0.25% plus 8 mg dexamethasone Receives: Procedure: Serratus anterior block |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Visual analogue scale from 0 to 10. 0= NO pain, 1-3=mild tolerable pain, 4-6= moderate pain, 7-10= severe untearable pain.
Measured: immediate after injection, 1 week, 1, 3 months
Secondary outcomes (3)
Number of patients with pain recurrence
Number of patients in need for re-injection
Measured: 1 week, 1, and 3 months
analgesic consumption
total amount dose of analgesics used
Measured: 1 week, 1, and 3 months
Incidence of treatment related adverse events
hypotension, bradyarrhythmia, hematoma
Measured: immediately after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start5 Jul 2024 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Herpes Zoster NeuropathyStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476080
- Sponsor's protocol ID
- 1084
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Serratus Anterior Versus Erector Spinae Block in Pain Alleviation in Acute Herpes Zoster: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT06476080
- Acronym / sponsor ID
- 1084
- Conditions
- Acute Herpes Zoster Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 5 Jul 2024 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 26 Jun 2024 (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.
Acute herpes zoster pain is very severe . Conventional analgesics may be of no value. Regional blocks may play a role
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion) |
| Erector spinae group | Active comparator | Procedure: ultrasound guided erector spine block800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion)+ 25 ml bupivacaine 0.25% plus 8 mg dexamethasone |
| Serratus anterior group | Active comparator | Procedure: Serratus anterior block800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion)+ 25 ml bupivacaine 0.25% plus 8 mg dexamethasone |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult population between 30 and 75 years old.
- Unilateral painful thoracic herpetic eruption of less than one week duration.
- VAS more than or equal 4, persistent pain in spite of proper antiviral and analgesic therapy, (800 mg oral acyclovir, 5 times per day, for one week), pregabalin 300 mg per day, acetaminophen 1000 mg per day, topical calamine lotion).
Key exclusion criteria (8 listed)
- Diabetic patients.
- Painful herpetic eruptive vesicles more than one week.
- Abdominal herpetic eruptions.
- Non-compliant on anti-viral (bulbar palsy for example).
- Co-malignancy or radiotherapy.
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 erector spine blockUltrasound guided thoracic erector spinae block | Procedure or surgery | Erector spinae group |
| Serratus anterior blockUltrasound guided serratus anterior block | Procedure or surgery | Serratus anterior group |
Primary outcome
pain score
Time frame: immediate after injection, 1 week, 1, 3 months
Visual analogue scale from 0 to 10. 0= NO pain, 1-3=mild tolerable pain, 4-6= moderate pain, 7-10= severe untearable pain.
3 secondary outcomes
Number of patients with pain recurrence
Time frame: 1 week, 1, and 3 months
analgesic consumption
Time frame: 1 week, 1, and 3 months
Incidence of treatment related adverse events
Time frame: immediately after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided erector spine block and Serratus anterior block in people with Acute Herpes Zoster Neuropathy, run by Minia University.
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 8 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: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
pain score (time frame: immediate after injection, 1 week, 1, 3 months). 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 27 Jun 2024.