Postherpetic NeuralgiaPhase 3NCT07349680
Ultrasound-Guided Thoracic Paravertebral Block With Steroid and Local Anesthetic for Acute Herpes Zoster: Effects on Pain Control and Prevention of Postherpetic Neuralgia
A Phase 3 study testing Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy) and Ultrasound-guided thoracic paravertebral block (TPVB) with bupivacaine 0.25% + methylprednisolone 40 mg in people with Postherpetic Neuralgia, run by Assiut University at 1 site in Egypt.
Trial summary
Background: Acute herpes zoster causes severe neuropathic pain and may progress to postherpetic neuralgia (PHN). This study aims to evaluate ultrasound-guided thoracic paravertebral block with local anesthetic and steroid in reducing acute pain and PHN incidence. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy) and Ultrasound-guided thoracic paravertebral block (TPVB) with bupivacaine 0.25% + methylprednisolone 40 mg
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to 10 Oct 2025
- Phase
- Phase 3
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Contraindications to thoracic paravertebral block, including:
- Coagulopathy
- Infection at the injection site
- Allergy to local anesthetics or steroids
- Immunosuppression or ongoing chemotherapy
- Pre-existing chronic pain in the same affected region
- Severe cognitive impairment or psychiatric illness preventing reliable pain assessment
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Thoracic Paravertebral Block With Steroid and Local Anesthetic for Acute Herpes Zoster: Effects on Pain Control and Prevention of Postherpetic Neuralgia: A Randomized Controlled Trial
Background: Acute herpes zoster causes severe neuropathic pain and may progress to postherpetic neuralgia (PHN). This study aims to evaluate ultrasound-guided thoracic paravertebral block with local anesthetic and steroid in reducing acute pain and PHN incidence.
Methods: This prospective randomized study included 100 patients diagnosed with acute thoracic herpes zoster (rash ≤14 days, NRS ≥4). Participants were allocated into two groups: a control group receiving standard medical treatment and an intervention group receiving standard treatment in addition to an ultrasound-guided thoracic paravertebral block with (0.25% bupivacaine + 40 mg methylprednisolone) at 48-72-hour intervals. Pain intensity was assessed at baseline and during follow-up. The incidence of postherpetic neuralgia was recorded. Secondary outcomes included analgesic consumption and patient satisfaction.
- Conditions
- Postherpetic Neuralgia
- Being tested
- Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy), Ultrasound-guided thoracic paravertebral block (TPVB) with bupivacaine 0.25% + methylprednisolone 40 mg
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy)Drug
Participants received standard medical therapy consisting of:
Valacyclovir 1000 mg orally three times daily for 7 days
Paracetamol (Acetaminophen) 1 g orally twice daily for 14 days
Gabapentin starting at 300 mg/day, titrated according to pain intensity and tolerance, up to a maximum of 1800 mg/day
Ultrasound-guided thoracic paravertebral block (TPVB) with bupivacaine 0.25% + methylprednisolone 40 mgProcedure or surgery
Participants received an ultrasound-guided thoracic paravertebral block (TPVB) using an injectate volume of 15 mL, consisting of:
Bupivacaine 0.25% (local anesthetic)
Methylprednisolone 40 mg (corticosteroid)
The block was performed at the thoracic level corresponding to maximal pain/dermatomal involvement, and was repeated every 48 hours for a total of three sessions.
| Study group | Role | What they receive |
|---|---|---|
| Standard medical therapy for acute thoracic herpes zoster | Other | Participants received standard medical therapy consisting of:
Valacyclovir 1000 mg orally three times daily for 7 days
Paracetamol (Acetaminophen) 1 g orally twice daily for 14 days
Gabapentin starting at 300 mg/day, titrated according to pain intensity and tolerance, up to a maximum of 1800 mg/day Receives: Drug: Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy) |
| Ultrasound-guided thoracic paravertebral block (TPVB) with local anesthetic + corticosteroid | Active comparator | Participants received an ultrasound-guided thoracic paravertebral block (TPVB) using an injectate volume of 15 mL, consisting of:
Bupivacaine 0.25% (local anesthetic)
Methylprednisolone 40 mg (corticosteroid)
The block was performed at the thoracic level corresponding to maximal pain/dermatomal involvement, and was repeated every 48 hours for a total of three sessions. Receives: Drug: Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy); Procedure: Ultrasound-guided thoracic paravertebral block (TPVB) with bupivacaine 0.25% + methylprednisolone 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the incidence of postherpetic neuralgia (PHN), defined as a Numerical Rating Scale (NRS) pain score ≥4 persisting 90 days after rash onset.
The primary outcome was the incidence of postherpetic neuralgia (PHN), defined as a Numerical Rating Scale (NRS) pain score ≥4 persisting 90 days after rash onset.
Measured: till 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Mar 2023
- Primary completion20 Sep 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Assiut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa mahmoud Abd El Rady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349680
- Sponsor's protocol ID
- 20260230004
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Plan Description De-identified individual participant data (IPD) will not be shared outside the study team. Access Criteria Not applicable.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Thoracic Paravertebral Block With Steroid and Local Anesthetic for Acute Herpes Zoster: Effects on Pain Control and Prevention of Postherpetic Neuralgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07349680
- Acronym / sponsor ID
- 20260230004
- Conditions
- Postherpetic Neuralgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 20 Jan 2026 (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.
Background: Acute herpes zoster causes severe neuropathic pain and may progress to postherpetic neuralgia (PHN). This study aims to evaluate ultrasound-guided thoracic paravertebral block with local anesthetic and steroid in reducing acute pain and PHN incidence.
Methods: This prospective randomized study included 100 patients diagnosed with acute thoracic herpes zoster (rash ≤14 days, NRS ≥4). Participants were allocated into two groups: a control group receiving standard medical treatment and an intervention group receiving standard treatment in addition to an ultrasound-guided thoracic paravertebral block with (0.25% bupivacaine + 40 mg methylprednisolone) at 48-72-hour intervals. Pain intensity was assessed at baseline and during follow-up. The incidence of postherpetic neuralgia was recorded. Secondary outcomes included analgesic consumption and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard medical therapy for acute thoracic herpes zoster | Other | Drug: Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy)Participants received standard medical therapy consisting of: Valacyclovir 1000 mg orally three times daily for 7 days Paracetamol (Acetaminophen) 1 g orally twice daily for 14 days Gabapentin starting at 300 mg/day, titrated according to pain intensity and tolerance, up to a maximum of 1800 mg/day |
| Ultrasound-guided thoracic paravertebral block (TPVB) with local anesthetic + corticosteroid | Active comparator | Drug: Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy), Procedure: Ultrasound-guided thoracic paravertebral block (TPVB) with bupivacaine 0.25% + methylprednisolone 40 mgParticipants received an ultrasound-guided thoracic paravertebral block (TPVB) using an injectate volume of 15 mL, consisting of: Bupivacaine 0.25% (local anesthetic) Methylprednisolone 40 mg (corticosteroid) The block was performed at the thoracic level corresponding to maximal pain/dermatomal involvement, and was repeated every 48 hours for a total of three sessions. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Coagulopathy
- Infection at the injection site
- Allergy to local anesthetics or steroids
- Immunosuppression or ongoing chemotherapy
- Pre-existing chronic pain in the same affected region
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 |
|---|---|---|
| Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy)Participants received standard medical therapy consisting of: Valacyclovir 1000 mg orally three times daily for 7 days Paracetamol (Acetaminophen) 1 g orally twice daily for 14 days Gabapentin starting at 300 mg/day, titrated according to pain intensity and tolerance, up to a maximum of 1800 mg/day | Drug | Standard medical therapy for acute thoracic herpes zoster, Ultrasound-guided thoracic paravertebral block (TPVB) with local anesthetic + corticosteroid |
| Ultrasound-guided thoracic paravertebral block (TPVB) with bupivacaine 0.25% + methylprednisolone 40 mgParticipants received an ultrasound-guided thoracic paravertebral block (TPVB) using an injectate volume of 15 mL, consisting of: Bupivacaine 0.25% (local anesthetic) Methylprednisolone 40 mg (corticosteroid) The block was performed at the thoracic level corresponding to maximal pain/dermatomal involvement, and was repeated every 48 hours for a total of three sessions. | Procedure or surgery | Ultrasound-guided thoracic paravertebral block (TPVB) with local anesthetic + corticosteroid |
Primary outcome
The primary outcome was the incidence of postherpetic neuralgia (PHN), defined as a Numerical Rating Scale (NRS) pain score ≥4 persisting 90 days after rash onset.
Time frame: till 3 month
The primary outcome was the incidence of postherpetic neuralgia (PHN), defined as a Numerical Rating Scale (NRS) pain score ≥4 persisting 90 days after rash onset.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. Plan Description De-identified individual participant data (IPD) will not be shared outside the study team. Access Criteria Not applicable.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy) and Ultrasound-guided thoracic paravertebral block (TPVB) with bupivacaine 0.25% + methylprednisolone 40 mg in people with Postherpetic Neuralgia, run by Assiut University at 1 site in Egypt.
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 0 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: finished, as of the sponsor's last update on 20 Jan 2026. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome was the incidence of postherpetic neuralgia (PHN), defined as a Numerical Rating Scale (NRS) pain score ≥4 persisting 90 days after rash onset. (time frame: till 3 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 20 Jan 2026.