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NCT Number: NCT07000409

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11651, Egypt

Location status: Recruiting

Location contact

Ahmed M Mohamed, MD

SUB_INVESTIGATOR

Ahmed Z Mohamed, MD

SUB_INVESTIGATOR

Amany E Ayad, MD

SUB_INVESTIGATOR

Marwa S Zayed, MD

SUB_INVESTIGATOR

Nada R Radwan, Master

CONTACT

[email protected]

00201114595879

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Medical management regimen

Other

Patients will receive the standard medical regimen alone.

Other names: Paracetamol +-Gabapentin + Amitriptyline

Erector spinae plane (ESP) block

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of side effects

    Time frame: 8 weeks after the first clinic visit.

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

  2. Incidence of side effects

    Time frame: 8 weeks after the first clinic visit.

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

  3. Tramadol consumption in both groups.

    Time frame: 8 weeks after the first clinic visit.

    Total consumption of tramadol in both groups will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Nada R Radwan, Master

CONTACT

[email protected]

00201114595879

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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