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

NCT07000409 | Recruiting

• 1 other identifier: MD-261-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postherpetic Neuralgia; Chronic Pain; Ultrasound Guidance; Erector Spinae Plane Block; Betamethasone

Outcome Measures

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.

  8 weeks after the first clinic visit.

Secondary Outcomes (3)

• Incidence of side effects

  8 weeks after the first clinic visit.

• Incidence of side effects

  8 weeks after the first clinic visit.

• Tramadol consumption in both groups.

  8 weeks after the first clinic visit.

Study Arms (2)

Med group

ACTIVE COMPARATOR

Patients will receive the standard medical regimen alone.

Other: Medical management regimen

Erector spinae plane block group

EXPERIMENTAL

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

Other: Erector spinae plane (ESP) block

Interventions

Medical management regimen OTHER

Patients will receive the standard medical regimen alone.

Also known as: Paracetamol +-Gabapentin + Amitriptyline

Med group

Erector spinae plane (ESP) block OTHER

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

Erector spinae plane block group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11651, Egypt

RECRUITING

MeSH Terms

Conditions

Neuralgia, Postherpetic; Chronic Pain

Interventions

Amitriptyline; Parapsychology; Dental Occlusion

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Nada R Radwan, Master

CONTACT

00201114595879; nadarefaat1994@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesia, surgical ICU and pain management, Faculty of medicine, Cairo University

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 2, 2025
• Study Start: May 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)