Patient SatisfactionNCT06761924
Predicting Ultrasound-Guided Thoracic PVB Success in Herpetic Neuralgia
A study testing Ultrasound-Guided Thoracic Paravertebral nerve block in people with Patient Satisfaction, run by Beni-Suef University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Ultrasound-Guided Thoracic Paravertebral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Beni Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, 62814
Dina M Fakhry, MD, 0201289998680, dina_fakhry_91@yahoo.com
Dina M Fakhry, MD, +201289998680, dina_fakhry_91@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Satisfaction
- Being tested
- Ultrasound-Guided Thoracic Paravertebral nerve block
- Keywords
- Thoracic paravertebral nerve block, Herpetic neuralgia, Pain relief
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Thoracic Paravertebral nerve blockProcedure or surgery
The patients will receive ultrasound-guided TPVB with 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone (10 mL volume)
Ultrasound-Guided Thoracic Paravertebral nerve blockProcedure or surgery
ultrasound-guided TPVB with 10 mL of saline without knowing which treatment they are receiving, maintaining blinding throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| TPVB group | Active comparator | patients will receive ultrasound-guided TPVB with 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone (10 mL volume) Receives: 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 Receives: Procedure: Ultrasound-Guided Thoracic Paravertebral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline , 24 hours , 2 weeks ,6 weeks , 3 months and 6 months post- intervention
Secondary outcomes (1)
Patient satisfaction
At baseline , 24 hours ,2week, 6week, 3 months and 6 months post- intervention using TreatmentSatisfaction Questionnaire for Medication (TSQM v1.4)
Measured: 24 hours,2 weeks ,6 weeks, 3 months and 6 months post- intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mahmoud Fakhry, Beni-Suef University
- Investigators
- Dina M Fakhry, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761924
- Sponsor's protocol ID
- FMBSUREC/01092024/Yousef
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Response to Ultrasound-Guided Thoracic Paravertebral Nerve Block in Patients With Herpetic Neuralgia
- ClinicalTrials.gov ID
- NCT06761924
- Acronym / sponsor ID
- FMBSUREC/01092024/Yousef
- Conditions
- Patient Satisfaction
- Keywords
- Thoracic paravertebral nerve block, Herpetic neuralgia, Pain relief
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPVB group | Active comparator | Procedure: Ultrasound-Guided Thoracic Paravertebral nerve blockpatients will receive ultrasound-guided TPVB with 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone (10 mL volume) |
| Control group | Placebo comparator | Procedure: Ultrasound-Guided Thoracic Paravertebral nerve blockultrasound-guided TPVB with 10 mL of saline without knowing which treatment they are receiving, maintaining blinding throughout the study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged from18 to 70 years
- Diagnosed with herpetic neuralgia.
- Able and willing to provide informed consent.
- ASA I - II
- One dermatomal affection
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Thoracic Paravertebral nerve blockThe patients will receive ultrasound-guided TPVB with 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone (10 mL volume) | Procedure or surgery | TPVB group |
| Ultrasound-Guided Thoracic Paravertebral nerve blockultrasound-guided TPVB with 10 mL of saline without knowing which treatment they are receiving, maintaining blinding throughout the study. | Procedure or surgery | Control group |
Primary outcome
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
1 secondary outcome
Patient satisfaction
Time frame: 24 hours,2 weeks ,6 weeks, 3 months and 6 months post- intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dina M Fakhry, MD principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Thoracic Paravertebral nerve block in people with Patient Satisfaction, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina M Fakhry, MD (+201289998680, drdina.mahmoud@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numeric Pain Rating Scale (NRS) (time frame: baseline , 24 hours , 2 weeks ,6 weeks , 3 months and 6 months post- intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.