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

Erector Spinae Plane Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04656821
• Other study ID #: 32720/11/18
• Status: Recruiting
• Phase: Phase 4
• Start date: December 5, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: December 2020
• Source: Tanta University
• Contact: Esraa Hassan Abdelwahab, MSc
• Phone: +201010473318
• Email: esraa.hassan[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 20, 2021
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Thoracic Herpes Zoster
• Aneurysm, Dissecting
• Erector Spinae Plane Block
• Herpes Zoster
• Pain Relief
• Thoracic Paravertebral Block

Intervention

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

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.
• 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

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of post herpetic neuralgia (PHN)	Persistent herpetic pain after 3 months will reported as post herpetic neuralgia (PHN)	3 months
Secondary	Visual Analog Scale	Visual Analog Scale (VAS) at baseline, 3, 4, 12, 24 weeks	6 months
Secondary	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
Secondary	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
Secondary	Adverse effects and complications	Hypotension; Pneumothorax; Local anesthetic toxicity; Respiratory depression	1 day