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

Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Thoracic Paravertebral Block for Pain Relief in Patients With Acute Thoracic Herpes Zoster

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.

Study Overview

• Status: Unknown
• Conditions: Erector Spinae Plane Block; Pain Relief; Thoracic Paravertebral Block; Acute Thoracic Herpes Zoster
• Intervention / Treatment: Drug: Control Rx; Procedure: Erector Spinae Block; Procedure: Thoracic Paravertebral Block

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Tanta University Hospitals
    • Contact: Esraa Hassan Abdelwahab, MSc; Phone Number: +201010473318; Email: esraa.hassan@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control Group; 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; 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
EXPERIMENTAL: Erector Spinae Block (ESB) group; 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; 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.
EXPERIMENTAL: Thoracic Paravertebral Block group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of post herpetic neuralgia (PHN)	Persistent herpetic pain after 3 months will reported as post herpetic neuralgia (PHN)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Visual Analog Scale (VAS) at baseline, 3, 4, 12, 24 weeks	6 months
Total consumption of rescue analgesia	Rescue analgesia in the form of Acetaminophen in a dose of 1,000 mg will be given if Visual Analog Scale (VAS) ≥4	6 months
The times of complete resolution of pain	The times of complete resolution of pain (from the date of block until complete disappearance of herpetic pain)	3 months
Adverse effects and complications	Hypotension; Pneumothorax; Local anesthetic toxicity; Respiratory depression	1 day

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2020
• Primary Completion (ANTICIPATED): June 6, 2021
• Study Completion (ANTICIPATED): June 20, 2021

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (ACTUAL): December 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Aneurysm; Herpes Zoster; Aneurysm, Dissecting; Herpes Simplex
• Other Study ID Numbers: 32720/11/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No