Predicting Ultrasound-Guided Thoracic PVB Success in Herpetic Neuralgia

NCT06761924 | Recruiting

• 1 other identifier: FMBSUREC/01092024/Yousef
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Satisfaction

Keywords

Thoracic paravertebral nerve block; Herpetic neuralgia; Pain relief

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction

  24 hours,2 weeks ,6 weeks, 3 months and 6 months post- intervention.

Study Arms (2)

TPVB group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Interventions

Ultrasound-Guided Thoracic Paravertebral nerve block PROCEDURE

The patients will receive ultrasound-guided TPVB with 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone (10 mL volume)

TPVB group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62814, Egypt

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dina M Fakhry, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina M Fakhry, MD

CONTACT

+201289998680; drdina.mahmoud@med.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start: February 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

EG (1)