Erector Spinae Block Versus Thoracic Paravertebral Block for Acute Thoracic Herpes Zoster

NCT04656821 | Unknown Phase 4

• 1 other identifier: 32720/11/18
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research is to study and compare the efficacy and safety of single injection erector spinae plane block and thoracic paravertebral block in prevention of post herpetic neuralgia in patients with acute thoracic herpes zoster.

Conditions

Acute Thoracic Herpes Zoster; Erector Spinae Plane Block; Thoracic Paravertebral Block; Pain Relief

Outcome Measures

Primary Outcomes (1)

• The incidence of post herpetic neuralgia (PHN)

  Persistent herpetic pain after 3 months will reported as post herpetic neuralgia (PHN)

  3 months

Secondary Outcomes (4)

• Visual Analog Scale

  6 months

• Total consumption of rescue analgesia

  6 months

• The times of complete resolution of pain

  3 months

• Adverse effects and complications

  1 day

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Patients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed.

Drug: Control Rx

Erector Spinae Block (ESB) group

EXPERIMENTAL

Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography. The concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography.

Procedure: Erector Spinae Block

Thoracic Paravertebral Block group

EXPERIMENTAL

Patients will receive 25 mg bupivacaine 0.5%, plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at the desired level under ultrasonography

Procedure: Thoracic Paravertebral Block

Interventions

Control Rx DRUG

Patients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed

Control Group

Erector Spinae Block PROCEDURE

Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography.

Erector Spinae Block (ESB) group

Thoracic Paravertebral Block PROCEDURE

Patients of this group will receive 25 mg bupivacaine 0.5% , plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at desired level under ultrasonography

Thoracic Paravertebral Block group

Eligibility Criteria

• Age: 51 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 50 years of age
• Chest wall herpetic eruption of less than one week
• Moderate or severe pain

You may not qualify if:

• Patient refusal
• Eruption more than one week duration
• Patients who will not receive appropriate anti-viral therapy
• Patients with mild pain
• Infection at the site of injection
• Patients with a history of renal, hepatic diseases, coagulopathy, steroid therapy, malignancies.
• Patient taking chemotherapy and/or radiotherapy.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Egypt

RECRUITING

MeSH Terms

Interventions

Tin Fluorides

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Esraa Hassan Abdelwahab, MSc

CONTACT

+201010473318; esraa.hassan@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 7, 2020
• Study Start: December 5, 2020
• Primary Completion: June 6, 2021
• Study Completion: June 20, 2021
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)