Predictors of Response to Ultrasound-Guided Thoracic Paravertebral Nerve Block in Patients With Herpetic Neuralgia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Beni-Suef University
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- The Numeric Pain Rating Scale (NRS)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TPVB group
patients will receive ultrasound-guided TPVB with 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone (10 mL volume)
Intervention: Ultrasound-Guided Thoracic Paravertebral nerve block (Procedure)
Control group
ultrasound-guided TPVB with 10 mL of saline without knowing which treatment they are receiving, maintaining blinding throughout the study
Intervention: Ultrasound-Guided Thoracic Paravertebral nerve block (Procedure)
Outcomes
Primary Outcomes
The Numeric Pain Rating Scale (NRS)
Time Frame: baseline , 24 hours , 2 weeks ,6 weeks , 3 months and 6 months post- intervention
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
Secondary Outcomes
- Patient satisfaction(24 hours,2 weeks ,6 weeks, 3 months and 6 months post- intervention.)
Investigators
Dina Mahmoud Fakhry
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management
Beni-Suef University