Postherpetic NeuralgiaNCT07000409
The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia.
A study testing Medical management regimen and Erector spinae plane (ESP) block in people with Postherpetic Neuralgia and Chronic Pain, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate the effectiveness of ultra-Sound guided Erector spinae block (ESB) with Betamethasone as an adjuvant to standard medical protocol in the management of truncal chronic post herpetic neuralgia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postherpetic Neuralgia, Chronic Pain, Ultrasound Guidance
- What is being tested?
- Medical management regimen and Erector spinae plane (ESP) block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 30 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age between 18 and 75.
- Patients with American Society of Anesthesiologists (ASA) II and III status.
- Patients diagnosed with truncal chronic post herpetic neuralgia( neuropathic pain persistent for more than 3 months from the onset of rash appearance )
Who cannot join
- Patients unable to comprehend the informed consent.
- Patients on long term opioid regimens.
- Patients with impairment in hepatic (Alanine aminotransferase (ALT) >50 U/L, and/or Aspartate aminotransferase (AST): >45 U/L) or renal functions( creatinine level ≥1.5 mg/dL)
- Patients on anti-coagulation regimens.
- Patients with coagulation abnormalities (i.e. international normalized ratio (INR) ≥1.5 and/or platelets ≤50000)
- Local infection in the site of the block.
- Patients with body mass index (BMI) > 35.
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
Cairo University
Cairo, 11651
Nada R Radwan, Master, 00201114595879, nadarefaat1994@gmail.com
Amany E Ayad, MD
About this study
Official title: The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia, a Prospective Randomized Controlled Study.
To investigate the effectiveness of ultra-Sound guided Erector spinae block (ESB) with Betamethasone as an adjuvant to standard medical protocol in the management of truncal chronic post herpetic neuralgia.
Read the detailed description
Postherpetic neuralgia (PHN) is a syndrome described as zoster-associated pain persisting for more than 3 months after resolution of an initial herpes zoster (HZ) rash ("shingles").[This condition is considered to be the most prevalent and challenging complication associated with HZ infection. According to reports, around 75% of senior patients who contract HZ are likely to experience it. The incidence of it was observed to be 38.1%, 27.0%, and 19.0% at 1 month, 3 months, and 6 months, respectively, following the onset of zoster. Half of the patients who are more than 50 years have the risk of developing PHN. It is noteworthy that the incidence of PHN seems to be on the rise.
Erector spinae plane (ESP) block is one of the newer interfascial techniques where the drug is injected below the erector spinae muscle to spread towards the costotransverse foramina and origin of dorsal and ventral rami where it is supposed to work at the origin of spinal nerves, based on cadaveric and contrast studies. Cadaveric studies have also showed that a block at T5 level is sufficient to have unilateral multi-dermatomal sensory block ranging from T1 to L3. Thus, this block serves the purpose of a paravertebral block without the risk of pleural injury.
Betamethasone is a long-acting corticosteroid with immunosuppressive and anti-inflammatory properties. It can be used topically to manage inflammatory skin conditions such as eczema, and parenterally to manage several disease states including autoimmune disorders. Betamethasone has potent glucocorticoid activity and negligible mineralocorticoid activity. The beneficial effects of injecting steroids could be because of sympathetic blockage, thereby inhibiting vasoconstriction and due to anaesthetization of the dorsal root ganglion and posterior spinal nerve.
- Conditions
- Postherpetic Neuralgia, Chronic Pain, Ultrasound Guidance, Erector Spinae Plane Block, Betamethasone
- Being tested
- Medical management regimen, Erector spinae plane (ESP) block
- Medical subject headings
- Neuralgia, Postherpetic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical management regimenOther
Also called Paracetamol +-Gabapentin + Amitriptyline
Patients will receive the standard medical regimen alone.
Erector spinae plane (ESP) blockOther
Patients will receive erector spinae plane (ESP) block with betamethasone with standard medical regimen.
| Study group | Role | What they receive |
|---|---|---|
| Med group | Active comparator | Patients will receive the standard medical regimen alone. Receives: Other: Medical management regimen |
| Erector spinae plane block group | Experimental | Patients will receive erector spinae plane (ESP) block with betamethasone with standard medical regimen. Receives: Other: Erector spinae plane (ESP) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain degree
The degree of pain will be obtained and recorded on a numeric rating scale (NRS) with 0=no pain, and 10=Maximum pain intensity. Pain NRS score will be assessed at 2,4,6,8 weeks after the first clinic visit.
Measured: 8 weeks after the first clinic visit.
Secondary outcomes (3)
Incidence of side effects
Incidence of side effects for medications regimen (excessive sleepiness, nausea, vomiting allergic reaction, diarrhea, blurred vision, disorientation).
Measured: 8 weeks after the first clinic visit.
Incidence of side effects
Incidence of side effects for ESP block (local hematoma, limb numbness or weakness, dizziness, pneumothorax, hypotension, infection, allergic reaction).
Measured: 8 weeks after the first clinic visit.
Tramadol consumption in both groups.
Total consumption of tramadol in both groups will be recorded
Measured: 8 weeks after the first clinic visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start1 May 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Refaat Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000409
- Sponsor's protocol ID
- MD-261-2024
- Status last verified
- Jun 2025
- First submitted
- 24 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia, a Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07000409
- Acronym / sponsor ID
- MD-261-2024
- Conditions
- Postherpetic Neuralgia, Chronic Pain, Ultrasound Guidance, Erector Spinae Plane Block, Betamethasone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Jun 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.
To investigate the effectiveness of ultra-Sound guided Erector spinae block (ESB) with Betamethasone as an adjuvant to standard medical protocol in the management of truncal chronic post herpetic neuralgia.
Detailed description
Postherpetic neuralgia (PHN) is a syndrome described as zoster-associated pain persisting for more than 3 months after resolution of an initial herpes zoster (HZ) rash ("shingles").[This condition is considered to be the most prevalent and challenging complication associated with HZ infection. According to reports, around 75% of senior patients who contract HZ are likely to experience it. The incidence of it was observed to be 38.1%, 27.0%, and 19.0% at 1 month, 3 months, and 6 months, respectively, following the onset of zoster. Half of the patients who are more than 50 years have the risk of developing PHN. It is noteworthy that the incidence of PHN seems to be on the rise.
Erector spinae plane (ESP) block is one of the newer interfascial techniques where the drug is injected below the erector spinae muscle to spread towards the costotransverse foramina and origin of dorsal and ventral rami where it is supposed to work at the origin of spinal nerves, based on cadaveric and contrast studies. Cadaveric studies have also showed that a block at T5 level is sufficient to have unilateral multi-dermatomal sensory block ranging from T1 to L3. Thus, this block serves the purpose of a paravertebral block without the risk of pleural injury.
Betamethasone is a long-acting corticosteroid with immunosuppressive and anti-inflammatory properties. It can be used topically to manage inflammatory skin conditions such as eczema, and parenterally to manage several disease states including autoimmune disorders. Betamethasone has potent glucocorticoid activity and negligible mineralocorticoid activity. The beneficial effects of injecting steroids could be because of sympathetic blockage, thereby inhibiting vasoconstriction and due to anaesthetization of the dorsal root ganglion and posterior spinal nerve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Med group | Active comparator | Other: Medical management regimenPatients will receive the standard medical regimen alone. |
| Erector spinae plane block group | Experimental | Other: Erector spinae plane (ESP) blockPatients will receive erector spinae plane (ESP) block with betamethasone with standard medical regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age between 18 and 75.
- Patients with American Society of Anesthesiologists (ASA) II and III status.
- Patients diagnosed with truncal chronic post herpetic neuralgia( neuropathic pain persistent for more than 3 months from the onset of rash appearance )
Key exclusion criteria (7 listed)
- Patients unable to comprehend the informed consent.
- Patients on long term opioid regimens.
- Patients with impairment in hepatic (Alanine aminotransferase (ALT) >50 U/L, and/or Aspartate aminotransferase (AST): >45 U/L) or renal functions( creatinine level ≥1.5 mg/dL)
- Patients on anti-coagulation regimens.
- Patients with coagulation abnormalities (i.e. international normalized ratio (INR) ≥1.5 and/or platelets ≤50000)
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 |
|---|---|---|
| Medical management regimenAlso: Paracetamol +-Gabapentin + AmitriptylinePatients will receive the standard medical regimen alone. | Other | Med group |
| Erector spinae plane (ESP) blockPatients will receive erector spinae plane (ESP) block with betamethasone with standard medical regimen. | Other | Erector spinae plane block group |
Primary outcome
Pain degree
Time frame: 8 weeks after the first clinic visit.
The degree of pain will be obtained and recorded on a numeric rating scale (NRS) with 0=no pain, and 10=Maximum pain intensity. Pain NRS score will be assessed at 2,4,6,8 weeks after the first clinic visit.
3 secondary outcomes
Incidence of side effects
Time frame: 8 weeks after the first clinic visit.
Incidence of side effects
Time frame: 8 weeks after the first clinic visit.
Tramadol consumption in both groups.
Time frame: 8 weeks after the first clinic visit.
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 5 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical management regimen and Erector spinae plane (ESP) block in people with Postherpetic Neuralgia and Chronic Pain, run by Cairo 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 3 inclusion and 7 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 5 Jun 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. 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 Nada R Radwan, Master (00201114595879, nadarefaat1994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain degree (time frame: 8 weeks after the first clinic visit.). 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 5 Jun 2025.