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

Phase 4

• Conditions: Acute Thoracic Herpes Zoster; Erector Spinae Plane Block; Pain Relief; Thoracic Paravertebral Block
• Interventions: Procedure: Thoracic Paravertebral Block; Drug: Control Rx; Procedure: Erector Spinae Block

• Registration Number: NCT04656821
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Study Start: 2020-12-05
• Last Update Submitted: 2020-12-06
• Study First Posted: 2020-12-07
• Last Update Posted: 2020-12-08
• Primary Completion: 2021-06-06
• Study Completion: 2021-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic Paravertebral Block group	Thoracic Paravertebral Block	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
Control Group	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.
Erector Spinae Block (ESB) group	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 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.

Primary Outcome Measures

Name	Time	Method
The incidence of post herpetic neuralgia (PHN)	3 months	Persistent herpetic pain after 3 months will reported as post herpetic neuralgia (PHN)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Egypt