Predicting Ultrasound-Guided Thoracic PVB Success in Herpetic Neuralgia

Predictors of Response to Ultrasound-Guided Thoracic Paravertebral Nerve Block in Patients With Herpetic Neuralgia

This study aims to fill the knowledge gap by investigating the predictors of success for TPVB in patients with herpetic neuralgia. By identifying demographic, clinical, previous medications and procedural factors associated with positive outcomes, this research seeks to enhance the efficacy of TPVB and improve pain management strategies for patients suffering from herpetic neuralgia.

Study Overview

• Status: Recruiting
• Conditions: Patient Satisfaction
• Intervention / Treatment: Procedure: Ultrasound-Guided Thoracic Paravertebral nerve block; Procedure: Ultrasound-Guided Thoracic Paravertebral nerve block

Detailed Description

Herpes zoster (HZ) is characterized by a unilateral dermatomal vesicular rash and severe discomfort along the affected dermatome. It is often caused by the reactivation of previously latent varicella zoster viruses (VZV) in cases of impaired cellular immunity.

According to recent population-based research , the overall incidence of HZ is almost 6.64/1000 person-years in the population aged 50 years or over, and it rises with age.

The most prevalent and severe side effect of HZ is post-herpetic neuralgia (PHN), which is commonly described as pain that lasts for 90 days after the rash first appears. Age-related increases in PHN incidence range from 5 to 30%, with patients over 50 having a higher risk if they have severe acute pain, a rash with many lesions, or strong prodromal symptoms.

Regretfully, there hasn't been a treatment that consistently reduces PHN discomfort up until now. Data from much research showed that patients may have significant clinical and financial burdens as a result of HZ and its consequences.

Analgesics are typically also needed, even though the availability of antiviral medications can speed up the end of viral shedding and quicken the healing of rash. Furthermore, it has no discernible effect on the development of PHN. As a result, it is crucial to start a methodical treatment plan that might have a preventative impact on PHN. It has been demonstrated that paravertebral nerve block is effective in treating acute pain in HZ patients, and it appears to have a greater antiviral treatment-induced reduction in PHN incidence.

Thoracic paravertebral block ( TPVB) involves the injection of local anesthetics and steroids adjacent to the thoracic vertebrae, resulting in the blockade of spinal nerves. This technique can provide segmental anesthesia and prolonged pain relief, making it a valuable tool in the anesthesiologist's repertoire. While TPVB is commonly used for postoperative analgesia in thoracic surgery, its application in managing herpetic neuralgia pain is relatively underexplored as the most recent evidence was published in 2023. Despite the potential benefits of TPVB in treating herpetic neuralgia, there is limited understanding of the factors that predict its success. Identifying these predictors could optimize patient selection and improve outcomes, but current literature on this topic is sparse.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina M Fakhry, MD; Phone Number: +201289998680; Email: drdina.mahmoud@med.bsu.edu.eg

Study Locations

• Egypt
  • Beni Suef
    • Banī Suwayf, Beni Suef, Egypt, 62814
      • Recruiting
      • Beni suef University hospital
      • Contact: Dina M Fakhry, MD; Phone Number: 0201289998680; Email: dina_fakhry_91@yahoo.com
      • Contact: Dina M Fakhry, MD; Phone Number: +201289998680; Email: dina_fakhry_91@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged from18 to 70 years
• Diagnosed with herpetic neuralgia.
• Able and willing to provide informed consent.
• ASA I - II
• One dermatomal affection
• Thoracic distribution

Exclusion Criteria:

• Contraindications to TPVB as ( Infection at site of injection, empyema , coagulopathy and neoplastic lesion occupying the paravertebral space)
• Known allergies to study medications (bupivacaine, Dexamethasone).
• Severe comorbidities that could interfere with study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TPVB group; patients will receive ultrasound-guided TPVB with 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone (10 mL volume)	Procedure: Ultrasound-Guided Thoracic Paravertebral nerve block; The patients will receive ultrasound-guided TPVB with 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone (10 mL volume); Procedure: Ultrasound-Guided Thoracic Paravertebral nerve block; ultrasound-guided TPVB with 10 mL of saline without knowing which treatment they are receiving, maintaining blinding throughout the study.
Placebo Comparator: Control group; ultrasound-guided TPVB with 10 mL of saline without knowing which treatment they are receiving, maintaining blinding throughout the study	Procedure: Ultrasound-Guided Thoracic Paravertebral nerve block; The patients will receive ultrasound-guided TPVB with 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone (10 mL volume); Procedure: Ultrasound-Guided Thoracic Paravertebral nerve block; ultrasound-guided TPVB with 10 mL of saline without knowing which treatment they are receiving, maintaining blinding throughout the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Numeric Pain Rating Scale (NRS)	The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours. The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours	baseline , 24 hours , 2 weeks ,6 weeks , 3 months and 6 months post- intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	At baseline , 24 hours ,2week, 6week, 3 months and 6 months post- intervention using TreatmentSatisfaction Questionnaire for Medication (TSQM v1.4)	24 hours,2 weeks ,6 weeks, 3 months and 6 months post- intervention.

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Dina M Fakhry, MD, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Pain relief; Herpetic neuralgia; Thoracic paravertebral nerve block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: FMBSUREC/01092024/Yousef

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No