CClinicalTrials.gg
RecruitingNCT07000409Updated Jun 5, 2025

The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia.

An interventional study of Medical management regimen and Erector spinae plane (ESP) block in Postherpetic Neuralgia, Chronic Pain and Ultrasound Guidance, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Postherpetic Neuralgia
  • Chronic Pain
  • Ultrasound Guidance
  • Erector Spinae Plane Block
  • Betamethasone
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's planned enrollment of 40 is below the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 )

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Med group

    Patients will receive the standard medical regimen alone.

    Other: Medical management regimen

  • Experimental
    Erector spinae plane block group

    Patients will receive erector spinae plane (ESP) block with betamethasone with standard medical regimen.

    Other: Erector spinae plane (ESP) block

Interventions

  • OtherMedical management regimen

    Patients will receive the standard medical regimen alone.

    Also known as: Paracetamol +-Gabapentin + Amitriptyline

  • OtherErector spinae plane (ESP) block

    Patients will receive erector spinae plane (ESP) block with betamethasone with standard medical regimen.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks after the first clinic visit.

Secondary outcomes

  1. Incidence of side effects

    Incidence of side effects for medications regimen (excessive sleepiness, nausea, vomiting allergic reaction, diarrhea, blurred vision, disorientation).

    Time frame: 8 weeks after the first clinic visit.

  2. Incidence of side effects

    Incidence of side effects for ESP block (local hematoma, limb numbness or weakness, dizziness, pneumothorax, hypotension, infection, allergic reaction).

    Time frame: 8 weeks after the first clinic visit.

  3. Tramadol consumption in both groups.

    Total consumption of tramadol in both groups will be recorded

    Time frame: 8 weeks after the first clinic visit.

07

Study locations

1 of 1 sites recruiting
  • Cairo University
    Cairo, 11651, Egypt
    • Nada R Radwan, Master · Contact · nadarefaat1994@gmail.com · 00201114595879
    • Amany E Ayad, MD · Sub investigator
    • Ahmed Z Mohamed, MD · Sub investigator
    • Marwa S Zayed, MD · Sub investigator
    • Ahmed M Mohamed, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07000409
Lead sponsor
Cairo University
Responsible party
Nada Refaat Eid (Assistant lecturer of Anesthesia, surgical ICU and pain management, Faculty of medicine, Cairo University, Cairo University) — Principal investigator
First posted
Jun 2, 2025
Start date
May 1, 2025
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jun 5, 2025

Study contacts

Nada R Radwan, Master
Contact
nadarefaat1994@gmail.com
00201114595879

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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