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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04656821
Other study ID # 32720/11/18
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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