- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07349680
Ultrasound-Guided Thoracic Paravertebral Block With Steroid and Local Anesthetic for Acute Herpes Zoster: Effects on Pain Control and Prevention of Postherpetic Neuralgia
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Asyut, Egypt, 1987
- Marwa Mahmoud Rady
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Eligibility Criteria Inclusion Criteria
Age 45-65 years
Diagnosed with acute thoracic herpes zoster
Rash duration ≤ 14 days
Moderate to severe pain, defined as NRS ≥ 4
Total sample size: 100 patients
Exclusion Criteria
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Standard medical therapy for acute thoracic herpes zoster
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 |
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 |
|
Active Comparator: Ultrasound-guided thoracic paravertebral block (TPVB) with local anesthetic + corticosteroid
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. |
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 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
till 3 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neuralgia, Postherpetic
- Amino Acids, Peptides, and Proteins
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Hydrocarbons
- Cyclohexanes
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Acids, Acyclic
- Carboxylic Acids
- Polycyclic Compounds
- Anilides
- Amides
- Aniline Compounds
- Amines
- Acetanilides
- Guanine
- Hypoxanthines
- Purinones
- Purines
- Amino Acids
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Pregnadienetriols
- gamma-Aminobutyric Acid
- Aminobutyrates
- Butyrates
- Acids, Carbocyclic
- Cyclohexanecarboxylic Acids
- Prednisolone
- Acyclovir
- Gabapentin
- Valacyclovir
- Acetaminophen
- Methylprednisolone
Other Study ID Numbers
- 20260230004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Plan Description
De-identified individual participant data (IPD) will not be shared outside the study team.
Access Criteria
Not applicable.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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