Ultrasound-Guided Thoracic Paravertebral Block With Steroid and Local Anesthetic for Acute Herpes Zoster: Effects on Pain Control and Prevention of Postherpetic Neuralgia

NCT07349680 | Completed Phase 3 FDA Drug

• 1 other identifier: 20260230004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  till 3 month

Study Arms (2)

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

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.

Drug: Valacyclovir + Paracetamol (Acetaminophen) + Gabapentin (standard medical therapy); Procedure: Ultrasound-guided thoracic paravertebral block (TPVB) with bupivacaine 0.25% + methylprednisolone 40 mg

Interventions

Ultrasound-guided thoracic paravertebral block (TPVB) with bupivacaine 0.25% + methylprednisolone 40 mg PROCEDURE

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.

Ultrasound-guided thoracic paravertebral block (TPVB) with local anesthetic + corticosteroid

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

Standard medical therapy for acute thoracic herpes zoster; Ultrasound-guided thoracic paravertebral block (TPVB) with local anesthetic + corticosteroid

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Marwa Mahmoud Rady

Asyut, 1987, Egypt

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Valacyclovir; Acetaminophen; Gabapentin; Methylprednisolone

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical proffessor

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 20, 2026
• Study Start: March 15, 2023
• Primary Completion: September 20, 2025
• Study Completion: October 10, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)